Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.

Official Title
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A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias

Conditions
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Dyskinesias, Drug-induced

Intervention / Treatment
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* Drug: AQW051
* Drug: AQW051
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Parkinson's disease Patients with dyskinesias for at least 3 months Patients with moderate to severe dyskinesias Patients on L-dopa treatment for at least 3 years Exclusion Criteria: Patients with atypical Parkinson's disease Patients who have had prior surgery for Parkinson's disease Patients who are cognitively impaired, have psychosis, have confusional states or hallucinate Patients who received neuroleptics or anti-psychotics within 2 months Women of child-bearing potential Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AQW051 High Dose<br>AQW051 high dose daily given orally for 28 days. | Drug: AQW051<br>* Patients will receive AQW051 in a high dose once daily orally for 28 days.<br>|
| Experimental: AQW051 Low Dose<br>AQW051 low dose daily given orally for 28 days. | Drug: AQW051<br>* Patients will receive AQW051 in a low dose once daily orally for 28 days.<br>|
| Placebo Comparator: Placebo<br>Placebo daily given orally for 28 days. | Drug: Placebo<br>* Patients will receive placebo once daily orally for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score | Dyskinesia with a maximal score of 24. | Baseline, Day 28 | 
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score | Anti-parkinsonian effect in PD patients. | Baseline, Day 28 | 
| Safety and tolerability | Safety and tolerability of AQW051 as measured by the number of participants with adverse events, any clinically significant abnormalities in safety labs or electrocardiograms (ECGs), and relevant orthostatic changes in blood pressure | Up to Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) | Assesses the degree to which dyskinesia interferes with five activities of daily living, with a higher score indicating more severe impairment. | Up to Day 42 | 
| Unified Parkinson's Disease Rating Scale (UPDRS) - Part IV, #32-33 | Dyskinesias as a percentage of the day, and disability due to dyskinesia during the previous week. | Up to Day 42 | 
| Track-PD | Objective measures of motor function. | Up to Day 42 | 
| CogState | Cognitive function, including simple and choice reaction time, episodic visual and verbal memory, working memory, planning and strategy, and executive function. | Up to Day 28 | 
| Area under the curve (AUC[0-24hr]) of AQW051 |  | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Dyskinesia, Movement disorders, L-dopa