13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

  
41 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004702-17-IT
(EUCTR)
07/11/201804/11/2020A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND Multiple sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE
Product Name: Formistin 10 mg
Product Code: [Formistin 10 mg]
Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE
Product Name: Tachipirina
Product Code: [Tachipirina CPR 500mg]
Other descriptive name: paracetamolo 500 mg
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: Solumedrol IM 125mg/2ml
Product Code: [Metilprednisolone]
Other descriptive name: Metilprednisolone sodio succinato
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: Ofatumumab
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: OFATUMUMAB
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia
2EUCTR2016-001515-20-IT
(EUCTR)
20/10/201607/02/2018ndEFFECT OF TERIFLUNOMIDE ON T CELL SUBPOPULATIONS INPERIPHERAL BLOOD FROM RRMS PATIENTS - nd RELAPSING-REMITTING MULTIPLE SCLEROSIS
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) - 28 COMPRESSE
Product Name: teriflunomide
Product Code: nd
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINULLNot RecruitingFemale: yes
Male: yes
30Phase 4Italy
3EUCTR2016-000708-26-IT
(EUCTR)
23/09/201622/06/2021NDEvaluation of clinical response in relation to the immunological status change in RRMS patients treated with Gilenya (fingolimod) for 12 months. - nd Relapsing Remitting Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE - BLISTER(PVC/PVDC/ALU) SCATOLA DA 28 CAPSULE
Product Name: Fingolimod
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORENULLNot RecruitingFemale: yes
Male: yes
50Phase 4Italy
4NCT02660359
(ClinicalTrials.gov)
July 8, 201614/1/2016Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units Of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple SclerosisUrinary Incontinence;Overactive BladderBiological: Botulinum toxin type A;Drug: PlaceboIpsenNULLTerminated18 Years80 YearsAll258Phase 3Argentina;Australia;Belgium;Brazil;Chile;Colombia;France;Germany;Israel;Lithuania;Mexico;Peru;Russian Federation;Spain;Ukraine;United Kingdom;New Zealand
5NCT02660138
(ClinicalTrials.gov)
March 201614/1/2016Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple SclerosisUrinary Incontinence;Overactive BladderBiological: Botulinum toxin type A;Drug: PlaceboIpsenNULLTerminated18 Years80 YearsAll227Phase 3United States;Canada;Czechia;Italy;Korea, Republic of;Netherlands;Poland;Portugal;Romania;Turkey;Czech Republic;Malaysia
6EUCTR2013-002283-25-IT
(EUCTR)
29/10/201308/10/2013A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
INN or Proposed INN: ND
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
INN or Proposed INN: ND
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
INN or Proposed INN: ND
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa
7EUCTR2012-000957-30-GB
(EUCTR)
05/03/201312/12/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: 9060X
INN or Proposed INN: Botulinum Toxin Type A
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
184France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom
8EUCTR2012-000957-30-PT
(EUCTR)
29/01/201312/11/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: 9060X
INN or Proposed INN: Botulinum Toxin Type A
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
184France;United States;Portugal;Czech Republic;Canada;Belgium;Poland;Russian Federation;United Kingdom
9EUCTR2012-000957-30-CZ
(EUCTR)
11/09/201218/06/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS)
MedDRA version: 17.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: 9060X
INN or Proposed INN: Botulinum Toxin Type A
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
184Portugal;France;United States;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom
10EUCTR2012-000957-30-BE
(EUCTR)
28/08/201201/06/2012BOTOX for the treatment of urinary incontinence in patients with bladder problems as a result of Multiple SclerosisBOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis Urinary incontinence due to neurogenic detrusor overactivity (NDO) resulting from multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: 9060X
INN or Proposed INN: Botulinum Toxin Type A
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
184France;United States;Portugal;Czech Republic;Canada;Poland;Belgium;Russian Federation;United Kingdom
11NCT01600716
(ClinicalTrials.gov)
June 13, 201215/5/2012Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)Urinary Incontinence;Multiple Sclerosis;Neurogenic BladderBiological: OnabotulinumtoxinA;Drug: Placebo (Normal Saline)AllerganNULLCompleted18 YearsN/AAll144Phase 3United States;Belgium;Canada;Czechia;France;Poland;Portugal;Russian Federation;Czech Republic
12EUCTR2010-023678-38-IT
(EUCTR)
20/04/201102/02/2011High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - NDHigh-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - ND patients with multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10028245
Trade Name: MANTADAN*20CPR 100MG
INN or Proposed INN: Amantadine
Trade Name: AMPYRA
INN or Proposed INN: Ampyra
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABORNULLNot RecruitingFemale: yes
Male: yes
Italy
13EUCTR2011-000770-60-IT
(EUCTR)
12/04/201101/09/2011An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - NDAn open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed.
MedDRA version: 14.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: other nervous system drugs
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
600Italy
14EUCTR2009-010788-18-IT
(EUCTR)
03/02/201131/05/2011An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - NDAn Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND Relapsing Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: MABCAMPATH
INN or Proposed INN: Alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Czech Republic;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
15EUCTR2010-023172-12-IT
(EUCTR)
13/01/201108/02/2011A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - NDA multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - ND Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245
Product Name: teriflunomide
Product Code: HMR1726
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726
INN or Proposed INN: teriflunomide
sanofi-aventis recherche et developmentNULLNot RecruitingFemale: yes
Male: yes
1455Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
16EUCTR2010-023023-19-IT
(EUCTR)
28/12/201019/11/2010A 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy. - NDA 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy. - ND relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Product Name: FINGOLIMOD
Product Code: FTY720D
Trade Name: EXTAVIA
INN or Proposed INN: Interferon beta-1b
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
Germany;Italy
17EUCTR2010-020515-37-IT
(EUCTR)
25/10/201014/09/2010A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis - ND A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis - ND MS (MULTIPLE SCLEROSIS)
MedDRA version: 9.1;Level: LLT;Classification code 10048393
Product Name: fingolimod
Product Code: FTY720D
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
5000Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
18EUCTR2009-012500-11-IT
(EUCTR)
18/06/201021/05/2010Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon ß-1a) in Patients with Relapsing Remitting Multiple Sclerosis - NDMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon ß-1a) in Patients with Relapsing Remitting Multiple Sclerosis - ND Relapsing Remitting Multiple Sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Daclizumab HYP
Other descriptive name: Daclizumab HYP
Trade Name: AVONEX
INN or Proposed INN: Interferon beta-1a
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
1500Slovenia;Greece;Finland;Spain;Ireland;Italy;United Kingdom;France;Czech Republic;Hungary;Denmark;Germany;Sweden
19EUCTR2008-004753-14-IT
(EUCTR)
07/06/201010/09/2010A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - ND A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - ND Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Product Code: BG00012BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
1700Phase 3Estonia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands
20EUCTR2009-015556-15-IT
(EUCTR)
07/06/201007/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - NDA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Trade Name: TYSABRI
INN or Proposed INN: Natalizumab
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
Trade Name: REBIF
INN or Proposed INN: Interferon beta-1a
Trade Name: REBIF*SC 12SIR 6000000UI 22MCG
INN or Proposed INN: Interferon beta-1a
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
21EUCTR2010-019029-32-IT
(EUCTR)
27/04/201009/04/2010A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - NDA 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND MS (MULTIPLE SCLEROSIS)
MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: fingolimod
Product Code: FTY720D
INN or Proposed INN: fingolimod
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;Germany;Netherlands;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Slovakia;Czech Republic;Denmark;Spain;Greece
22EUCTR2009-015815-42-IT
(EUCTR)
15/03/201001/03/2010A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - NDA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10063399
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1245Phase 3Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
23EUCTR2009-014392-51-IT
(EUCTR)
08/03/201011/12/2009A dose blinded extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis. - NDA dose blinded extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis. - ND multiple sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Code: BAF312
Product Code: BAF312
Product Code: BAF312
Product Code: BAF312
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
275Hungary;Finland;Poland;Spain;Germany;Italy
24EUCTR2009-012989-30-IT
(EUCTR)
06/10/200911/09/2009A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - NDA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND Relapsing - Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod
INN or Proposed INN: Laquinimod
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden
25EUCTR2008-006786-92-IT
(EUCTR)
29/09/200910/08/2009Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis. - NDMulticenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis. - ND Multiple Sclerosis Relapsing Remitting
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Product Name: ACT-128800
Product Code: ACT-128800
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
400Hungary;Finland;United Kingdom;Czech Republic;Netherlands;Bulgaria;France;Spain;Italy;Austria;Poland;Sweden
26EUCTR2008-008719-25-IT
(EUCTR)
08/04/200906/03/2009A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsingremitting multiple sclerosis - NDA phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsingremitting multiple sclerosis - ND multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Code: BAF312
Product Code: BAF312
Product Code: BAF312
Product Code: BAF312
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
275Phase 2Hungary;Finland;Germany;Spain;Italy
27EUCTR2006-003696-12-IT
(EUCTR)
18/11/200810/10/2008A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - ND Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Dimethyl Fumarate
Product Code: BG00012
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
1011Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden
28EUCTR2007-002627-32-IT
(EUCTR)
11/06/200816/05/2008A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - NDA double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 1.25mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - ND primary progressive multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis
Product Name: fingolimod
Product Code: FTY720D
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
650France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
29EUCTR2007-003997-24-IT
(EUCTR)
05/06/200813/06/2008Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - NDLong-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Sanofi-Aventis recherche & de'veloppementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
30EUCTR2008-001940-38-IT
(EUCTR)
22/04/200814/04/2008Functional RMN study to evaluate the prompt and middle term effect of the treatment with Donepezil in patients affected by multiple sclerosis and mild impairment of cognitive function. - NDFunctional RMN study to evaluate the prompt and middle term effect of the treatment with Donepezil in patients affected by multiple sclerosis and mild impairment of cognitive function. - ND patients affected by multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: ARICEPT
INN or Proposed INN: Donepezil
Trade Name: ARICEPT
INN or Proposed INN: Donepezil
OSPEDALE S. RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
31EUCTR2007-000192-42-IT
(EUCTR)
10/03/200831/07/2007A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - NDA Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity - ND urinary incontinence caused by neurogenic detrusor overactivity (spinal lesion or multiple sclerosis)
MedDRA version: 9.1;Level: LLT;Classification code 10029279;Term: Neurogenic bladder
Trade Name: BOTOX
INN or Proposed INN: Botulinum toxin
ALLERGANNULLNot RecruitingFemale: yes
Male: yes
260Portugal;United Kingdom;Germany;Netherlands;France;Spain;Italy
32EUCTR2008-000490-37-IT
(EUCTR)
26/02/200820/03/2008Pharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - NDPharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - ND multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028053;Term: MS
Trade Name: EBIXA
INN or Proposed INN: Memantine
OSPEDALE S. RAFFAELENULLNot RecruitingFemale: yes
Male: yes
40Phase 2Italy
33EUCTR2007-006268-32-IT
(EUCTR)
23/01/200823/11/2007EFFICACY AND SAFETYOF BOTULINUM TOXIN THERAPY ON UPPER LIMB SPASTICITY IN INFLAMMATORY AND DEMIELINIZZATING DISEASE OF CENTRAL NERVOUS SYSTEM. - NDEFFICACY AND SAFETYOF BOTULINUM TOXIN THERAPY ON UPPER LIMB SPASTICITY IN INFLAMMATORY AND DEMIELINIZZATING DISEASE OF CENTRAL NERVOUS SYSTEM. - ND multiple sclerosis
MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive
Trade Name: xeomin
INN or Proposed INN: xeomin
OSPEDALE S. RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
34EUCTR2007-000586-38-IT
(EUCTR)
21/12/200710/01/2008HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - NDHIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - ND PATIENTS AFFECTED BY MULTIPLE SCLEROSIS
MedDRA version: 6.1;Level: HLT;Classification code 10052785
Trade Name: THIOPLEX
INN or Proposed INN: Thiotepa
Trade Name: ENDOXAN BAXTER
INN or Proposed INN: Cyclophosphamide
Trade Name: NEUPOGEN
INN or Proposed INN: Filgrastim
OSPEDALE S. RAFFAELENULLNot RecruitingFemale: yes
Male: yes
30Phase 2Italy
35EUCTR2007-005414-40-IT
(EUCTR)
21/12/200728/11/2007Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - NDEfficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - ND Patients with an established and stable Multiple Sclerosis (according to Poser criteria).
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: KEPPRA
INN or Proposed INN: Levetiracetam
AZIENDA SANITARIA N. 3 GENOVESENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
36EUCTR2006-003134-14-IT
(EUCTR)
24/09/200724/07/2007A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis - NDA randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis - ND multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Sanofi-aventis U.S. IncNULLNot RecruitingFemale: yes
Male: yes
120Germany;Spain;Italy
37EUCTR2006-004893-29-IT
(EUCTR)
24/09/200724/07/2007A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis - NDA randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis - ND multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Sanofi-aventis U.S. Inc.NULLNot RecruitingFemale: yes
Male: yes
120Germany;United Kingdom;Italy;Austria
38EUCTR2006-003361-14-IT
(EUCTR)
23/05/200707/03/2007Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - NDLong-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse
Product Name: teriflunomide
Product Code: HMR1726D
Product Name: teriflunomide
Product Code: HMR1726D
sanofi-aventis recherche de veloppementNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
39EUCTR2005-005985-35-IT
(EUCTR)
05/09/200615/01/2007A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. - NDA 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. - ND relapsing forms of multiple sclerosis
MedDRA version: 6.1;Level: PT;Classification code 10028245
Product Code: BIRT 2584XX
Product Code: BIRT 2584 XX
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
400Czech Republic;Netherlands;Italy
40EUCTR2005-005679-13-IT
(EUCTR)
28/06/200623/06/2006An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - NDAn open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis. - ND multiple sclerosis
MedDRA version: 6.1;Level: PT;Classification code 10053395
INN or Proposed INN: NaltrexoneOSPEDALE S. RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Italy
41JPRN-JapicCTI-050031
06/09/2005Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval) [Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injuryIntervention name : Baclofen
Dosage And administration of the intervention : Intertheacal injection
DAIICHI SANKYO COMPANY, LIMITEDNULLBOTHPhase 4NULL