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

This study has been completed.

Sponsors and Collaborators:	Merck KGaA EMD Pharmaceuticals
Information provided by:	EMD Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00105521

Purpose

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).

Condition	Intervention	Phase
Parkinson's Disease Dyskinesia	Drug: Sarizotan HC1	Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Dopamine Dopamine hydrochloride Sarizotan Sarizotan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by EMD Pharmaceuticals:

Estimated Enrollment:	600
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105521

Show 32 Study Locations

Sponsors and Collaborators

Merck KGaA

EMD Pharmaceuticals

More Information

Study ID Numbers:	EMR 62225-019
Study First Received:	March 15, 2005
Last Updated:	November 30, 2006
ClinicalTrials.gov Identifier:	NCT00105521
Health Authority:	United States: Food and Drug Administration

Keywords provided by EMD Pharmaceuticals:

Parkinson's Disease
Dyskinesia
Dyskinesia associated with dopaminergic treatment

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Neurologic Manifestations
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Dyskinesias

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009