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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01474421

Collaborator

(none)

Enrollment

Locations

Arms

17.2

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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: AQW051 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

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 :

Sep 15, 2011

Actual Primary Completion Date :

Feb 21, 2013

Actual Study Completion Date :

Feb 21, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Sacramento	California	United States	95817
2	Novartis Investigative Site	Manhasset	New York	United States	11030
3	Novartis Investigative Site	Cincinnati	Ohio	United States	45219
4	Novartis Investigative Site	Cleveland	Ohio	United States	44195
5	Novartis Investigative Site	Bron		France	69677
6	Novartis Investigative Site	Clermont Fd		France	63003
7	Novartis Investigative Site	Lille Cedex		France	59037
8	Novartis Investigative Site	Marseille cedex 05		France	13385
9	Novartis Investigative Site	Montpellier cedex 5		France	34295
10	Novartis Investigative Site	Nantes Cedex 1		France	44093
11	Novartis Investigative Site	Paris		France	75013
12	Novartis Investigative Site	Pessac		France	33604
13	Novartis Investigative Site	Poitiers		France	86021
14	Novartis Investigative Site	Strasbourg		France	67098
15	Novartis Investigative Site	Toulouse cedex 9		France	31059
16	Novartis Investigative Site	Berlin		Germany	10178
17	Novartis Investigative Site	Dresden		Germany	01307
18	Novartis Investigative Site	Gera		Germany	07551
19	Novartis Investigative Site	Haag		Germany	83527
20	Novartis Investigative Site	Kassel		Germany	34128
21	Novartis Investigative Site	Marburg		Germany	35039
22	Novartis Investigative Site	Muenchen		Germany	80804
23	Novartis Investigative Site	Tübingen		Germany	72076
24	Novartis Investigative Site	Roma	RM	Italy	00163