MODAFINIL ( DrugBank: Modafinil )

4 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
49	全身性エリテマトーデス	1
93	原発性胆汁性胆管炎	1

6. パーキンソン病

臨床試験数 : 2,298 / 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2017-004475-31-CZ (EUCTR)	09/05/2018	09/05/2018	Safety 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.	NULL	Not 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): no	France;United States;Hungary;Czech Republic;Germany
2	EUCTR2017-004475-31-HU (EUCTR)	17/04/2018	09/02/2018	Safety 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.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	France;United States;Czech Republic;Hungary;Germany
3	NCT03083132 (ClinicalTrials.gov)	June 13, 2017	7/3/2017	Modafinil 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 Disease	Parkinson Disease	Drug: modafinil 50mg;Drug: Placebo oral capsule	University of Arkansas	NULL	Completed	50 Years	90 Years	All	23	Early Phase 1	United States
4	NCT02857244 (ClinicalTrials.gov)	November 2016	25/7/2016	A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients	A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients	Parkinson's Disease	Drug: Duloxetine;Drug: Donepezil;Drug: Modafinil	University of Chicago	NULL	Withdrawn	18 Years	100 Years	All	0	Phase 2	United States
5	JPRN-UMIN000019676	2015/11/10	10/11/2015	The 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 - The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease	Parkinson's disease	taking 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 Medicine	NULL	Complete: follow-up complete	20years-old	100years-old	Male and Female	20	Not selected	Japan
6	NCT00393562 (ClinicalTrials.gov)	March 2006	26/10/2006	Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease	Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease	Parkinson's Disease	Drug: modafinil;Drug: methylphenidate	Department of Veterans Affairs	NULL	Withdrawn	50 Years	80 Years	Both	0	N/A	United States

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13. 多発性硬化症／視神経脊髄炎

臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03621761 (ClinicalTrials.gov)	November 15, 2018	3/8/2018	Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue	A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis	Multiple Sclerosis	Behavioral: Telephone-based Cognitive Behavioral Therapy;Drug: Modafinil	University of Michigan	University of Washington;Patient-Centered Outcomes Research Institute;National Multiple Sclerosis Society	Completed	18 Years	N/A	All	336	Phase 4	United States
2	NCT03185065 (ClinicalTrials.gov)	October 4, 2017	9/6/2017	Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis	Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis	Fatigue in Multiple Sclerosis	Drug: Amantadine;Drug: Modafinil;Drug: Methylphenidate;Drug: Placebos	Johns Hopkins University	Patient-Centered Outcomes Research Institute	Completed	18 Years	N/A	All	141	Phase 3	United States
3	EUCTR2012-003418-15-AT (EUCTR)	23/10/2012	09/11/2012	Methylphenidate 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 Wien	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Austria
4	NCT00142402 (ClinicalTrials.gov)	June 2003	1/9/2005	Modafinil in Multiple Sclerosis	Modafinil for Improving New Learning and Memory in Multiple Sclerosis	Multiple Sclerosis	Drug: Modafinil	Kessler Foundation	National Multiple Sclerosis Society	Completed	18 Years	60 Years	Both	20	N/A	United States
5	NCT00210301 (ClinicalTrials.gov)	January 2003	13/9/2005	Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS	Combination Therapy (Provigil + Avonex) in the Treatment of Attention Problems in Patients With Relapsing-Remitting MS	Relapsing-Remitting Multiple Sclerosis	Drug: Provigil (modafinil)	Institute for Clinical Research	NULL	Recruiting	20 Years	65 Years	Both	60	N/A	United States

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49. 全身性エリテマトーデス

臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00297284 (ClinicalTrials.gov)	February 2006	24/2/2006	Memory and Attention Problems in Lupus: New Treatment Trial With Modafinil	Pilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE Patients	Systemic Lupus Erythematosus	Drug: Modafinil	Hospital for Special Surgery, New York	NULL	Terminated	18 Years	60 Years	Both	20	N/A	United States

93. 原発性胆汁性胆管炎

臨床試験数 : 282 / 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00943176 (ClinicalTrials.gov)	June 2009	17/7/2009	Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)	Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis	Fatigue;Primary Biliary Cirrhosis	Drug: Modafinil	Mayo Clinic	American College of Gastroenterology	Completed	21 Years	75 Years	Both	40	Phase 1	United States

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