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

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 Overview

• Status: Completed
• Conditions: Dyskinesias; Drug-induced
• Intervention / Treatment: Drug: AQW051; Drug: AQW051; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Novartis Investigative Site
  • Clermont Fd, France, 63003
    • Novartis Investigative Site
  • Lille Cedex, France, 59037
    • Novartis Investigative Site
  • Marseille cedex 05, France, 13385
    • Novartis Investigative Site
  • Montpellier cedex 5, France, 34295
    • Novartis Investigative Site
  • Nantes Cedex 1, France, 44093
    • Novartis Investigative Site
  • Paris, France, 75013
    • Novartis Investigative Site
  • Pessac, France, 33604
    • Novartis Investigative Site
  • Poitiers, France, 86021
    • Novartis Investigative Site
  • Strasbourg, France, 67098
    • Novartis Investigative Site
  • Toulouse cedex 9, France, 31059
    • Novartis Investigative Site
• Germany
  • Berlin, Germany, 10178
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Gera, Germany, 07551
    • Novartis Investigative Site
  • Haag, Germany, 83527
    • Novartis Investigative Site
  • Kassel, Germany, 34128
    • Novartis Investigative Site
  • Marburg, Germany, 35039
    • Novartis Investigative Site
  • Muenchen, Germany, 80804
    • Novartis Investigative Site
  • Tübingen, Germany, 72076
    • Novartis Investigative Site
• Italy
  • RM
    • Roma, RM, Italy, 00163
      • Novartis Investigative Site
• United States
  • California
    • Sacramento, California, United States, 95817
      • Novartis Investigative Site
  • New York
    • Manhasset, New York, United States, 11030
      • Novartis Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Novartis Investigative Site
    • Cleveland, Ohio, United States, 44195
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Trenkwalder C, Berg D, Rascol O, Eggert K, Ceballos-Baumann A, Corvol JC, Storch A, Zhang L, Azulay JP, Broussolle E, Defebvre L, Geny C, Gostkowski M, Stocchi F, Tranchant C, Derkinderen P, Durif F, Espay AJ, Feigin A, Houeto JL, Schwarz J, Di Paolo T, Feuerbach D, Hockey HU, Jaeger J, Jakab A, Johns D, Linazasoro G, Maruff P, Rozenberg I, Sovago J, Weiss M, Gomez-Mancilla B. A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. Mov Disord. 2016 Jul;31(7):1049-54. doi: 10.1002/mds.26569. Epub 2016 Mar 15.

Helpful Links

• Results for CAQW051A2209 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2011
• Primary Completion (Actual): February 21, 2013
• Study Completion (Actual): February 21, 2013

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 18, 2011

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Parkinson's disease; L-dopa; Movement disorders; Dyskinesia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias
• Other Study ID Numbers: CAQW051A2209; 2011-001092-39 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No