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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01474421

Enrollment

Registered

2011-11-18

Start date

2011-09-15

Completion date

2013-02-21

Last updated

2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-induced, Dyskinesias

Keywords

Parkinson's disease, Dyskinesia, Movement disorders, L-dopa

Brief summary

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.

Interventions

DRUGPlacebo

Patients will receive placebo once daily orally for 28 days.

DRUGAQW051

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score	Baseline, Day 28	Dyskinesia with a maximal score of 24.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score	Baseline, Day 28	Anti-parkinsonian effect in PD patients.
Safety and tolerability	Up to Day 42	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

Secondary

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

Countries

France, Germany, Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026