DDrare: Database of Drug Development for Rare 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	7
193	プラダー・ウィリ症候群	1

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	EUCTR2009-013886-24-SE (EUCTR)	08/06/2010	21/12/2009	Efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2	Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes	246		Czech Republic;Germany;Sweden
2	EUCTR2009-013886-24-DE (EUCTR)	03/03/2010	29/10/2009	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2	Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes	246		Czech Republic;Germany;Sweden
3	NCT01066442 (ClinicalTrials.gov)	March 2010	9/2/2010	Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease	A Randomised, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38 Week Open Label Extension Phase	Parkinson's Disease	Drug: BF2.649 (Pitolisant)	Bioprojet	NULL	Completed	30 Years	80 Years	Both	273	Phase 3	Germany
4	NCT01036139 (ClinicalTrials.gov)	December 2009	11/12/2009	Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease	A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase	Parkinson's Disease	Drug: BF2.649 (pitolisant)	Bioprojet	NULL	Completed	30 Years	80 Years	Both	268	Phase 3	France
5	EUCTR2009-013886-24-CZ (EUCTR)	26/11/2009	18/11/2009		A Randomized, Multicenter, 12-Week, Double-blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson Disease, followed by a 9-months Open-Label Extension Phase - HARPS-2	Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes	246	Phase -	Germany;Czech Republic;Sweden
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
6	EUCTR2009-013885-14-FR (EUCTR)	23/11/2009	25/09/2009	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase	Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	246	Phase A	France;Spain
7	EUCTR2009-013885-14-ES (EUCTR)	12/11/2009	23/09/2009	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.	Excessive daytime sleepiness in Parkinson?s DiseaseSomnolencia diurna excesiva en la enfermedad de Parkinson. MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	246		France;Spain

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

EUCTR2009-013886-24-SE
(EUCTR)

08/06/2010

21/12/2009

Efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease

A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2

Excessive daytime sleepiness in Parkinson’s Disease
MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant

BIOPROJET

NULL

Not Recruiting

Female: yes
Male: yes

246

Czech Republic;Germany;Sweden

EUCTR2009-013886-24-DE
(EUCTR)

03/03/2010

29/10/2009

A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2

Excessive daytime sleepiness in Parkinson’s Disease
MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness
MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism

BIOPROJET

NULL

Not Recruiting

Female: yes
Male: yes

246

Czech Republic;Germany;Sweden

NCT01066442
(ClinicalTrials.gov)

March 2010

9/2/2010

Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease

A Randomised, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38 Week Open Label Extension Phase

Parkinson's Disease

Drug: BF2.649 (Pitolisant)

Bioprojet

NULL

Completed

30 Years

80 Years

Both

273

Phase 3

Germany

NCT01036139
(ClinicalTrials.gov)

December 2009

11/12/2009

Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease

A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase

Parkinson's Disease

Drug: BF2.649 (pitolisant)

Bioprojet

NULL

Completed

30 Years

80 Years

Both

268

Phase 3

France

EUCTR2009-013886-24-CZ
(EUCTR)

26/11/2009

18/11/2009

A Randomized, Multicenter, 12-Week, Double-blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson Disease, followed by a 9-months Open-Label Extension Phase - HARPS-2

BIOPROJET

NULL

Not Recruiting

Female: yes
Male: yes

246

Phase -

Germany;Czech Republic;Sweden

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

EUCTR2009-013885-14-FR
(EUCTR)

23/11/2009

25/09/2009

A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase

Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant

BIOPROJET

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

246

Phase A

France;Spain

EUCTR2009-013885-14-ES
(EUCTR)

12/11/2009

23/09/2009

A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.

Excessive daytime sleepiness in Parkinson?s DiseaseSomnolencia diurna excesiva en la enfermedad de Parkinson.
MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness
MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism

Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant

BIOPROJET

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

246

France;Spain