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	EUCTR2006-004112-51-IT (EUCTR)	14/11/2006	04/12/2006	A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND	A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND	Parkinson s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: SIRIO30CPR EFF 25MG+100MG INN or Proposed INN: Melevodopa and decarboxylase inhibitor Trade Name: SINEMET50CPR 100MG+25MG INN or Proposed INN: LEVODOPA DC.IT FU INN or Proposed INN: CARBIDOPA FU	VERNALIS DEVELOPMENT LIMITED	NULL	Not Recruiting			Female: yes Male: yes			Italy
2	NCT00491998 (ClinicalTrials.gov)	November 2006	26/6/2007	PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets	Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets	Parkinson's Disease	Drug: V1512;Drug: V1512 and Entacapone	Vernalis (R&D) Ltd	Cita NeuroPharmaceuticals;INC Research	Completed	30 Years	N/A	Both	27	Phase 1;Phase 2	Italy

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

EUCTR2006-004112-51-IT
(EUCTR)

14/11/2006

04/12/2006

A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND

Parkinson s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Trade Name: SIRIO*30CPR EFF 25MG+100MG
INN or Proposed INN: Melevodopa and decarboxylase inhibitor
Trade Name: SINEMET*50CPR 100MG+25MG
INN or Proposed INN: LEVODOPA DC.IT FU
INN or Proposed INN: CARBIDOPA FU

VERNALIS DEVELOPMENT LIMITED

NULL

Not Recruiting

Female: yes
Male: yes

Italy

NCT00491998
(ClinicalTrials.gov)

November 2006

26/6/2007

PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets

Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets

Parkinson's Disease

Drug: V1512;Drug: V1512 and Entacapone

Vernalis (R&D) Ltd

Cita NeuroPharmaceuticals;INC Research

Completed

30 Years

N/A

Both

Phase 1;Phase 2

Italy