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	NCT04193527 (ClinicalTrials.gov)	July 2020	2/12/2019	A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients	A Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy Controls	Parkinsonian Syndrome;Parkinson Disease(PD);Multiple System Atrophy (MSA);Progressive Supranuclear Palsy (PSP)	Drug: DaTSCAN™ Ioflupane (123I) Injection	GE Healthcare	PPD	Not yet recruiting	40 Years	80 Years	All	172	Phase 3	China
2	EUCTR2015-003045-26-SE (EUCTR)	23/10/2015	15/09/2015	Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease.	[18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease.	Patients with newly clinically diagnosed untreated idiopathic parkinsonism MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: [18F]FE-PE2I INN or Proposed INN: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane Trade Name: DaTSCAN INN or Proposed INN: IOFLUPANE (123I) Product Name: 15O H2O INN or Proposed INN: [15O]H2O	Umeå University Hospital	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 2	Sweden
3	EUCTR2010-019894-13-IT (EUCTR)	17/02/2012	02/03/2012	The Parkinson's Progression Markers Initiative (PPMI)	The Parkinson's Progression Markers Initiative (PPMI) - PPMI	Parkinson Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]	Trade Name: DaTSCAN INN or Proposed INN: IOFLUPANE (123I)	MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600		Italy;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

NCT04193527
(ClinicalTrials.gov)

July 2020

2/12/2019

A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients

A Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy Controls

Parkinsonian Syndrome;Parkinson Disease(PD);Multiple System Atrophy (MSA);Progressive Supranuclear Palsy (PSP)

Drug: DaTSCAN™ Ioflupane (123I) Injection

GE Healthcare

PPD

Not yet recruiting

40 Years

80 Years

All

172

Phase 3

China

EUCTR2015-003045-26-SE
(EUCTR)

23/10/2015

15/09/2015

Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease.

[18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease.

Patients with newly clinically diagnosed untreated idiopathic parkinsonism
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: [18F]FE-PE2I
INN or Proposed INN: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane
Trade Name: DaTSCAN
INN or Proposed INN: IOFLUPANE (123I)
Product Name: 15O H2O
INN or Proposed INN: [15O]H2O

Umeå University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

105

Phase 2

Sweden

EUCTR2010-019894-13-IT
(EUCTR)

17/02/2012

02/03/2012

The Parkinson's Progression Markers Initiative (PPMI)

The Parkinson's Progression Markers Initiative (PPMI) - PPMI

Parkinson Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trade Name: DaTSCAN
INN or Proposed INN: IOFLUPANE (123I)

MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Italy;United States