Sarizotan HCl in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia

This study has been completed.

Sponsor:

Information provided by:

EMD Serono

ClinicalTrials.gov Identifier:

NCT00105521

First received: March 15, 2005

Last updated: November 4, 2010

Last verified: November 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	March 15, 2005
Last Updated Date	November 4, 2010
Start Date ^ICMJE	September 2004
Primary Completion Date	March 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00105521 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Sarizotan HCl in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia
Official Title ^ICMJE	A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
Brief Summary	The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Parkinson's Disease Dyskinesia
Intervention ^ICMJE	Drug: Sarizotan HC1
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	600
Completion Date	March 2006
Primary Completion Date	March 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: The subject is an out-patient. The subject presents with a diagnosis of idiopathic Parkinson's disease. Prior therapy with all registered Parkinsonian medication is allowed. Exclusion Criteria: (For female subjects) The subject is pregnant or lactating. The subject is participating in another clinical study or has done so within the past 30 days. The subject has received neurosurgical intervention related to PD. The subject has relevant renal impairment. The subject has relevant hepatic impairment. The subject is suffering from any dementia or psychiatric illness. The subject has a history of allergic asthma.
Gender	Both
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00105521
Other Study ID Numbers ^ICMJE	EMR 62225-019
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	EMD Serono
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	EMD Serono
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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