MODAFINIL ( DrugBank: Modafinil )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病6
13多発性硬化症/視神経脊髄炎5

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004475-31-CZ
(EUCTR)
09/05/201809/05/2018Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease. Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease Excessive daytime sleepiness associated with Parkinson’s disease
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Flecainide acetate
Product Code: THN02
INN or Proposed INN: Flecainidum
Other descriptive name: FLECAINIDE ACETATE
Product Name: Flecainide acetate
Product Code: THN02
INN or Proposed INN: Flecainidum
Other descriptive name: FLECAINIDE ACETATE
Trade Name: Modiodal
Product Name: over-encapsulated Modafinil
INN or Proposed INN: MODAFINIL
Theranexus S.A.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Czech Republic;Germany
2EUCTR2017-004475-31-HU
(EUCTR)
17/04/201809/02/2018Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease.Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease Excessive daytime sleepiness associated with Parkinson’s disease
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Flecainide acetate
Product Code: THN02
INN or Proposed INN: Flecainidum
Other descriptive name: FLECAINIDE ACETATE
Product Name: Flecainide acetate
Product Code: THN02
INN or Proposed INN: Flecainidum
Other descriptive name: FLECAINIDE ACETATE
Trade Name: Modiodal
Product Name: over-encapsulated Modafinil
INN or Proposed INN: MODAFINIL
Theranexus S.A.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Czech Republic;Hungary;United States;France;Germany
3NCT03083132
(ClinicalTrials.gov)
June 13, 20177/3/2017Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's DiseaseParkinson DiseaseDrug: modafinil 50mg;Drug: Placebo oral capsuleUniversity of ArkansasNULLCompleted50 Years90 YearsAll23Early Phase 1United States
4NCT02857244
(ClinicalTrials.gov)
November 201625/7/2016A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson PatientsA Multidisciplinary Approach to Manage Gait Difficulty in Parkinson PatientsParkinson's DiseaseDrug: Duloxetine;Drug: Donepezil;Drug: ModafinilUniversity of ChicagoNULLWithdrawn18 Years100 YearsAll0Phase 2United States
5JPRN-UMIN000019676
2015/11/1010/11/2015The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's diseaseThe double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease - The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease Parkinson's diseasetaking modafinil (200 mg/day) after breakfast for 4 weeks, wash out for 2 weeks, taking matching placebo after breakfast for 4 weeks
taking matching placebo after breakfast for 4 weeks, wash out for 2 weeks, taking modafinil (200 mg/day) after breakfast for 4 weeks
Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of MedicineNULLComplete: follow-up complete20years-old100years-oldMale and Female20Not selectedJapan
6NCT00393562
(ClinicalTrials.gov)
March 200626/10/2006Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's DiseaseComparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: modafinil;Drug: methylphenidateDepartment of Veterans AffairsNULLWithdrawn50 Years80 YearsBoth0N/AUnited States

13. 多発性硬化症/視神経脊髄炎


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03621761
(ClinicalTrials.gov)
November 15, 20183/8/2018Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis FatigueA Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple SclerosisMultiple SclerosisBehavioral: Telephone-based Cognitive Behavioral Therapy;Drug: ModafinilUniversity of MichiganUniversity of Washington;Patient-Centered Outcomes Research Institute;National Multiple Sclerosis SocietyCompleted18 YearsN/AAll343Phase 4United States
2NCT03185065
(ClinicalTrials.gov)
October 4, 20179/6/2017Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple SclerosisTreatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple SclerosisFatigue in Multiple SclerosisDrug: Amantadine;Drug: Modafinil;Drug: Methylphenidate;Drug: PlacebosJohns Hopkins UniversityPatient-Centered Outcomes Research InstituteCompleted18 YearsN/AAll141Phase 3United States
3EUCTR2012-003418-15-AT
(EUCTR)
23/10/201209/11/2012Methylphenidate modified release as treatment of MS-associated fatigue.Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial. Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Ritalin LA 20mg capsules
Product Name: Methylphenidate modified release 20 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Trade Name: Ritalin LA 30mg capsules
Product Name: Methylphenidate modified release 30 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Trade Name: Ritalin LA 40mg capsules
Product Name: Methylphenidate modified release 40 mg
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Medizinische Universität WienNULLNot RecruitingFemale: yes
Male: yes
96Phase 2Austria
4NCT00142402
(ClinicalTrials.gov)
June 20031/9/2005Modafinil in Multiple SclerosisModafinil for Improving New Learning and Memory in Multiple SclerosisMultiple SclerosisDrug: ModafinilKessler FoundationNational Multiple Sclerosis SocietyCompleted18 Years60 YearsBoth20N/AUnited States
5NCT00210301
(ClinicalTrials.gov)
January 200313/9/2005Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MSCombination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MSRelapsing-Remitting Multiple SclerosisDrug: Provigil (modafinil)Institute for Clinical ResearchNULLRecruiting20 Years65 YearsBoth60N/AUnited States