The purpose of this study is to evaluate the safety, tolerability and efficacy of eltoprazine to treat levodopa-induced dyskinesia in patients with Parkinson's disease
A double-blind, placebo-controlled, crossover, dose-range finding study in patients with Parkinson's disease and levodopa-induced dyskinesia. The study will examine the effects of three different doses of eltoprazine HCl, compared to placebo, on severity of dyskinesia, parkinsonian symptoms, patient function, safety and tolerability, using Parkinson's disease rating scales, patient diaries and physiological measurement of abnormal movement by means of motion sensors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
2.5 mg b.i.d. orally for 3 weeks
5.0 mg b.i.d. orally for 3 weeks
7.5 mg b.i.d. orally for 3 weeks
Parkinson's Disease and Movement Disorders Center, Boca Raton
Boca Raton, Florida, United States
Clinical impact of dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score
Clinical impact on dyskinesia measured by total UDysRS (Unified Dyskinesia Rating Scale) score at the end of each Treatment Period on Days 21, 42, 63 and 84
Time frame: 84 days
• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
• PD motor symptoms assessed by MDS-UPDRS, diaries and physiological measurement with motion sensor system
Time frame: 84 days
Dyskinesia severity using physiological motion sensor system
Dyskinesia severity using physiological motion sensor system
Time frame: 84 days
Patient function using MDS-UPDRS and UDysRS questionnaires quantify dyskinesia and Parkinsonian motor symptoms.
Patient function using MDS-UPDRS and UDysRS questionnaires
Time frame: 84 days
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
Safety and tolerability: adverse events, physical and neurological exams, safety laboratory values, vital signs and ECG
Time frame: 94 days
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b.i.d. orally for 3 weeks