Status:
COMPLETED
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
Lead Sponsor:
EMD Serono
Conditions:
Parkinson's Disease
Dyskinesia
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- (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.
Key Trial Info
Start Date :
September 30 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2006
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT00105508
Start Date
September 30 2004
End Date
February 28 2006
Last Update
July 26 2018
Active Locations (31)
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1
Birmingham, Alabama, United States, 35233
2
Huntsville, Alabama, United States, 35801
3
La Jolla, California, United States, 92037
4
Oxnard, California, United States, 93030