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

Phase 2

Completed

• Conditions: Dyskinesias; Drug-induced
• Interventions: Drug: AQW051; Drug: Placebo

• Registration Number: NCT01474421
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-15
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-18
• Primary Completion: 2013-02-21
• Study Completion: 2013-02-21
• Status Verified: 2017-05
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-26
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AQW051 Low Dose	AQW051	AQW051 low dose daily given orally for 28 days.
Placebo	Placebo	Placebo daily given orally for 28 days.
AQW051 High Dose	AQW051	AQW051 high dose daily given orally for 28 days.

Primary Outcome Measures

Name	Time	Method
Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score	Baseline, Day 28	Dyskinesia with a maximal score of 24.
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
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score	Baseline, Day 28	Anti-parkinsonian effect in PD patients.

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Roma, RM, Italy