Status:
COMPLETED
Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist
Lead Sponsor:
Newron Pharmaceuticals SPA
Conditions:
Idiopathic Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200 mg/day and Low Dose: 50 to 100 mg/day) orally, as compared to Placebo, as add-on therapy in patients with ea...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of idiopathic Parkinson's disease of less than 5 years duration, and a Hoehn and Yahr Stage of I to III,
- who were receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to Visit 1 (Screening).
Exclusion
- Patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;
- patients with a diagnosis or recent history of substance abuse,
- a history of psychosis,
- who were depressed,
- had evidence of dementia or cognitive dysfunction,
- or who were experiencing end of dose wearing-off;
- female patients of childbearing potential;
- patients who have previously received safinamide.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT00643045
Start Date
December 1 2004
End Date
July 1 2007
Last Update
March 25 2008
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