ADX48621 for 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Number of patients with abnormal safety and tolerability assessment parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Physical and neurological examination, heart rate and blood pressure, 12-lead ECG, hematology and biochemistry assessments, use of concomitant medications, adverse events and serious adverse events.
- Dyskinesia severity score measured by mAIMS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in Parkinson's disease severity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Patient diary at weeks 1, 2, 3 and 4, UPDRS Part III at weeks 2 and 4, UPDRS total score at week 4
- Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Other Name: Dipraglurant
|Placebo Comparator: ADX48621 Matching Placebo||
Other Name: Placebo
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336088
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|Study Director:||Addex Pharma||Addex Pharma|