2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details


臨床試験数 : 624 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225

  
20 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2019-000374-39-DE
(EUCTR)
04/10/201928/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
2EUCTR2019-000374-39-SE
(EUCTR)
26/09/201916/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
3NCT03836716
(ClinicalTrials.gov)
September 19, 20197/2/2019Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension TrialOpen Label, Non-randomized Extension Trial to Assess Long Term Safety and Efficacy of Arimoclomol in Subjects With Amyotropic Lateral Sclerosis Who Have Completed the ORARIALS-01 TrialAmyotrophic Lateral SclerosisDrug: ArimoclomolOrphazymeNULLTerminated18 YearsN/AAll120Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;Switzerland
4EUCTR2019-000374-39-PL
(EUCTR)
05/09/201922/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Sweden
5EUCTR2019-000374-39-NL
(EUCTR)
27/08/201929/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
6EUCTR2019-000374-39-ES
(EUCTR)
07/08/201911/06/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
231Phase 3United States;Spain;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
7EUCTR2019-000374-39-IT
(EUCTR)
15/07/201927/01/2021Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial - na Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: [BRX-345]
INN or Proposed INN: ARIMOCLOMOL
ORPHAZYME APSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
231Phase 3United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
8EUCTR2019-000374-39-GB
(EUCTR)
15/07/201909/05/2019Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis.Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
231Phase 3United States;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
9EUCTR2018-000137-13-BE
(EUCTR)
04/12/201813/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
10EUCTR2018-000137-13-NL
(EUCTR)
21/11/201818/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3France;United States;Canada;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden
11EUCTR2018-000137-13-GB
(EUCTR)
19/11/201807/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
231 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden
12EUCTR2018-000137-13-SE
(EUCTR)
22/10/201807/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
13EUCTR2018-000137-13-ES
(EUCTR)
19/10/201809/10/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
231Phase 3France;United States;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
14EUCTR2018-000137-13-PL
(EUCTR)
18/10/201802/10/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;France;Canada;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
15EUCTR2018-000137-13-IT
(EUCTR)
08/10/201822/01/2021A study to compare the use of Arimoclomol with placebo in patients withAmyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis - na Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: [BRX-345]
INN or Proposed INN: ARIMOCLOMOL
ORPHAZYME APSNULLNot RecruitingFemale: yes
Male: yes
231Phase 3France;United States;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
16EUCTR2018-000137-13-FR
(EUCTR)
05/10/201806/09/2018A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arimoclomol
Product Code: BRX-345
INN or Proposed INN: ARIMOCLOMOL
Orphazyme A/SNULLNot RecruitingFemale: yes
Male: yes
231Phase 3United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
17NCT03491462
(ClinicalTrials.gov)
July 31, 201827/3/2018Arimoclomol in Amyotropic Lateral SclerosisA Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Arimoclomol;Drug: Placebo oral capsuleOrphazymeNULLCompleted18 YearsN/AAll245Phase 3United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom;Denmark
18NCT00706147
(ClinicalTrials.gov)
January 200924/6/2008Phase II/III Randomized, Placebo-controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral SclerosisPhase II/III Randomized, Placebo-Controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Arimoclomol;Drug: PlaceboUniversity of MiamiMassachusetts General HospitalCompleted18 YearsN/AAll38Phase 2/Phase 3United States
19NCT00561366
(ClinicalTrials.gov)
January 200816/11/2007A Multicenter, Double-Blind Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With ALSA Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Placebo;Drug: ArimoclomolCytRxNULLWithdrawn18 YearsN/ABoth0Phase 2United States;Canada
20NCT00244244
(ClinicalTrials.gov)
October 200525/10/2005A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALSA Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)Drug: arimoclomolCytRxNULLCompleted18 YearsN/ABoth80Phase 2United States