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	3

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	NCT01560754 (ClinicalTrials.gov)	October 2012	9/3/2012	Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease	A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess the Disease-modifying Potential of Transdermal Nicotine in Early Parkinson's Disease in Germany and the USA	Parkinson's Disease	Drug: nicotine transdermal patch	James BOYD MD	Michael J. Fox Foundation for Parkinson's Research;Parkinson Study Group (PSG);International Parkinson Fonds (IPF);German Parkinson Study Group (GPS);German Parkinson Society (DPG);Philipps-University Marburg, Germany	Active, not recruiting	30 Years	N/A	Both	160	Phase 2	United States;Germany
2	EUCTR2010-020299-42-DE (EUCTR)	30/08/2011	26/04/2011	A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients.	A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD	Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE	Philipps-University Marburg	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Germany
3	NCT00873392 (ClinicalTrials.gov)	February 2009	31/3/2009	Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease	Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease(One Daily Administration).A Controlled Randomised Study, in Two Parallel Groups and Single Blind in 40 Patients.	Idiopathic Parkinson's Disease	Drug: Transdermal nicotine;Other: Usual drug treatment of Parkinson's disease	Assistance Publique - Hôpitaux de Paris	NULL	Completed	35 Years	70 Years	Both	40	Phase 2	France

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

NCT01560754
(ClinicalTrials.gov)

October 2012

9/3/2012

Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease

A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess the Disease-modifying Potential of Transdermal Nicotine in Early Parkinson's Disease in Germany and the USA

Parkinson's Disease

Drug: nicotine transdermal patch

James BOYD MD

Michael J. Fox Foundation for Parkinson's Research;Parkinson Study Group (PSG);International Parkinson Fonds (IPF);German Parkinson Study Group (GPS);German Parkinson Society (DPG);Philipps-University Marburg, Germany

Active, not recruiting

30 Years

N/A

Both

160

Phase 2

United States;Germany

EUCTR2010-020299-42-DE
(EUCTR)

30/08/2011

26/04/2011

A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients.

A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD

Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed
MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster
Product Name: Nicotinell
Other descriptive name: NICOTINE
Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster
Product Name: Nicotinell
Other descriptive name: NICOTINE

Philipps-University Marburg

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Germany

NCT00873392
(ClinicalTrials.gov)

February 2009

31/3/2009

Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease

Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease(One Daily Administration).A Controlled Randomised Study, in Two Parallel Groups and Single Blind in 40 Patients.

Idiopathic Parkinson's Disease

Drug: Transdermal nicotine;Other: Usual drug treatment of Parkinson's disease

Assistance Publique - Hôpitaux de Paris

NULL

Completed

35 Years

70 Years

Both

Phase 2

France