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	2

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	EUCTR2016-000657-12-IT (EUCTR)	16/02/2017	08/02/2017	A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation	Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD	Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 000000 Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 00000 Other descriptive name: Genz-682452-AU	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	276	Phase 2	Portugal;United States;Taiwan;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Singapore;Australia;Norway;Germany;Japan;Sweden
2	NCT02838797 (ClinicalTrials.gov)	June 2016	16/6/2016	RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease	RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease	Parkinson's Disease;Gastroparesis;Constipation	Drug: RQ-00000010;Drug: Placebo	Virginia Commonwealth University	Michael J. Fox Foundation for Parkinson's Research;RaQualia Pharma Inc.	Completed	18 Years	N/A	All	51	Phase 1	United States

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

EUCTR2016-000657-12-IT
(EUCTR)

16/02/2017

08/02/2017

A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation

Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD

Parkinson's disease (PD) carrying a GBA mutation
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: 000000
Other descriptive name: Genz-682452-AU
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: 00000
Other descriptive name: Genz-682452-AU

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

276

Phase 2

Portugal;United States;Taiwan;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Singapore;Australia;Norway;Germany;Japan;Sweden

NCT02838797
(ClinicalTrials.gov)

June 2016

16/6/2016

RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease

Parkinson's Disease;Gastroparesis;Constipation

Drug: RQ-00000010;Drug: Placebo

Virginia Commonwealth University

Michael J. Fox Foundation for Parkinson's Research;RaQualia Pharma Inc.

Completed

18 Years

N/A

All

Phase 1

United States