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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01474421
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : May 5, 2017
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Dyskinesias Drug-induced Drug: AQW051 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 15, 2011
Actual Primary Completion Date : February 21, 2013
Actual Study Completion Date : February 21, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa
U.S. FDA Resources

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.
Experimental: AQW051 Low Dose
AQW051 low dose daily given 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.

Primary Outcome Measures :
  1. Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score [ Time Frame: Baseline, Day 28 ]
    Dyskinesia with a maximal score of 24.

  2. Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score [ Time Frame: Baseline, Day 28 ]
    Anti-parkinsonian effect in PD patients.

  3. Safety and tolerability [ Time Frame: 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 Outcome Measures :
  1. Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) [ Time Frame: 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.

  2. Unified Parkinson's Disease Rating Scale (UPDRS) - Part IV, #32-33 [ Time Frame: Up to Day 42 ]
    Dyskinesias as a percentage of the day, and disability due to dyskinesia during the previous week.

  3. Track-PD [ Time Frame: Up to Day 42 ]
    Objective measures of motor function.

  4. CogState [ Time Frame: 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.

  5. Area under the curve (AUC[0-24hr]) of AQW051 [ Time Frame: Day 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01474421

United States, California
Novartis Investigative Site
Sacramento, California, United States, 95817
United States, New York
Novartis Investigative Site
Manhasset, New York, United States, 11030
United States, Ohio
Novartis Investigative Site
Cincinnati, Ohio, United States, 45219
Novartis Investigative Site
Cleveland, Ohio, United States, 44195
Novartis Investigative Site
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
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
Roma, RM, Italy, 00163
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01474421     History of Changes
Other Study ID Numbers: CAQW051A2209
2011-001092-39 ( EudraCT Number )
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Parkinson's disease
Movement disorders

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs