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

Novartis Pharmaceuticals71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dyskinesias Drug-induced

Interventions

AQW051DRUG

Patients will receive AQW051 in a high dose once daily orally for 28 days.

AQW051DRUG

Patients will receive AQW051 in a low dose once daily orally for 28 days.

PlaceboDRUG

Patients will receive placebo once daily orally for 28 days.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (24)

Novartis Investigative Site

Sacramento, California, United States

Outcomes

Primary Outcomes

Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score

Dyskinesia with a maximal score of 24.

Time frame: Baseline, Day 28

Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score

Anti-parkinsonian effect in PD patients.

Time frame: 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

Time frame: Up to Day 42

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to Day 42

Track-PD

Objective measures of motor function.

Time frame: 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.

Time frame: Up to Day 28

Data from ClinicalTrials.gov

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