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	EUCTR2006-005140-89-NL (EUCTR)	11/12/2006	01/12/2006	A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study	A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study	This postmarketing Phase I study is performed in healthy volunteers. The IMP rasagiline 1mg is indicated for the treatment of Parkinson's Disease (PD). MedDRA version: 9.1;Level: PT;Classification code 10061536	Trade Name: Selegiline HCl 5 PCH Trade Name: Nardil Product Name: Rasagiline 1mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate Product Name: Rasagiline 2 mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate	TEVA Pharmaceuticals Industries Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 1	Netherlands
2	NCT00203125 (ClinicalTrials.gov)	October 2000	13/9/2005	A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.	Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133)	Parkinson's Disease	Drug: rasagiline mesylate;Other: tyramine	Teva Pharmaceutical Industries	NULL	Completed	N/A	N/A	Both	55	Phase 3	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

EUCTR2006-005140-89-NL
(EUCTR)

11/12/2006

01/12/2006

A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study

This postmarketing Phase I study is performed in healthy volunteers. The IMP rasagiline 1mg is indicated for the treatment of Parkinson's Disease (PD).
MedDRA version: 9.1;Level: PT;Classification code 10061536

Trade Name: Selegiline HCl 5 PCH
Trade Name: Nardil
Product Name: Rasagiline 1mg tablet
Product Code: TVP-1012
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesilate
Product Name: Rasagiline 2 mg tablet
Product Code: TVP-1012
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesilate

TEVA Pharmaceuticals Industries Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 1

Netherlands

NCT00203125
(ClinicalTrials.gov)

October 2000

13/9/2005

A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.

Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133)

Parkinson's Disease

Drug: rasagiline mesylate;Other: tyramine

Teva Pharmaceutical Industries

NULL

Completed

N/A

Both

Phase 3

United States