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	NCT03648671 (ClinicalTrials.gov)	March 28, 2018	26/6/2018	Pain in Parkinson's Disease With Motor Fluctuations.	Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.	Parkinson Disease	Drug: safinamide metansolfonato (12 weeks);Drug: rasagilina mesilato (12 weeks)	Universita di Verona	Azienda Ospedaliera Universitaria Integrata Verona	Unknown status	18 Years	80 Years	All	48		Italy
2	EUCTR2014-002600-24-IT (EUCTR)	11/12/2015	16/02/2018	Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 20.0;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: Xadago Product Name: Safinamide Product Code: na INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO Trade Name: Xadago INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO	ZAMBON SPA	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden

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

NCT03648671
(ClinicalTrials.gov)

March 28, 2018

26/6/2018

Pain in Parkinson's Disease With Motor Fluctuations.

Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.

Parkinson Disease

Drug: safinamide metansolfonato (12 weeks);Drug: rasagilina mesilato (12 weeks)

Universita di Verona

Azienda Ospedaliera Universitaria Integrata Verona

Unknown status

18 Years

80 Years

All

Italy

EUCTR2014-002600-24-IT
(EUCTR)

11/12/2015

16/02/2018

Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complications

A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST

Idiopathic Parkinson's Disease
MedDRA version: 20.0;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: Xadago
Product Name: Safinamide
Product Code: na
INN or Proposed INN: SAFINAMIDE METANSOLFONATO
Other descriptive name: SAFINAMIDE METANSOLFONATO
Trade Name: Xadago
INN or Proposed INN: SAFINAMIDE METANSOLFONATO
Other descriptive name: SAFINAMIDE METANSOLFONATO

ZAMBON SPA

NULL

Not Recruiting

Female: yes
Male: yes

556

Phase 3

France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden