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PREMANDYSK: Amantadine for L-DOPA-induced Dyskinesia in Early Parkinson's Disease
NCT01538329Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2012
- Primary completion
- Feb 2018
- Countries
- 1
- Sponsor
- Centre hospitalier universitaire de Toulouse
- Modality
- Small Molecules
- Drugs
- amantadine
- Conditions
- Parkinson's disease (PD)
01
Overview
Phase 2, randomised trial in Parkinson's disease (PD) comparing Amantadine with Placebo (2 arms). Primary endpoint: Rate of subjects with abnormal involuntary dyskinetic movements at 18 months. Started Mar 2012; status: completed.
02
Design
2 arms- Study design
- Randomized
Amantadine
Amantadine 200 mg/day + L-DOPA
Placebo
Placebo + L-DOPA
03
Who it enrols
Patients over 35 with idiopathic Parkinson's disease diagnosed for <3 years, receiving L-DOPA for <1 year without complications, and on a stable antiparkinsonian treatment.
04
Endpoints
Primary
Rate of subjects with abnormal involuntary dyskinetic movements
Secondary
Abnormal involuntary dyskinetic movements at the end of phase 3
Motor fluctuations
Time to onset of dyskinesias
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