Parkinson's Disease Clinical Trial
Official title:
Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in
Parkinson's disease patients following four weeks of dosing.
The secondary objectives of the study include the evaluation of the efficacy of ADX48621
compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's;
the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient
ability to function, and the evaluation of the effect of coadministration of ADX48621 on
L-dopa efficacy.
First study of ADX48621 in male and female Parkinson's disease patients with levodopa-induced dyskinesia. Four weeks, double-blind, placebo-controlled dose titration from 50 mg once daily up to 100 mg three times daily, at the start of week 4. Safety and tolerability assessed by adverse events enquiry, heart rate and blood pressure, 12-lead ECG, haematology and biochemistry. Efficacy assessments include Abnormal Involuntary Movement Scale (AIMS), Unified Parkinson's Disease rating Scale (UPDRS) patient PD symptom diaries, Hospital Anxiety Depression Scale (HADS), patient and clinician global impression of change in PD and dyskinesia (PGIC and CGIC). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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