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

Dyskinesias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474421
• Other study ID #: CAQW051A2209
• Secondary ID: 2011-001092-39
• Status: Completed
• Phase: Phase 2
• Start date: September 15, 2011
• Est. completion date: February 21, 2013

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 21, 2013
• Est. primary completion date: February 21, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug-induced
• Dyskinesias

Intervention

Drug:
• AQW051
Patients will receive AQW051 in a high dose once daily orally for 28 days.
• AQW051
Patients will receive AQW051 in a low dose once daily orally for 28 days.
• Placebo
Patients will receive placebo once daily orally for 28 days.

Locations

Country	Name	City	State
France	Novartis Investigative Site	Bron
France	Novartis Investigative Site	Clermont Fd
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Marseille cedex 05
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Nantes Cedex 1
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Pessac
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Toulouse cedex 9
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Haag
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Tübingen
Italy	Novartis Investigative Site	Roma	RM
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Manhasset	New York
United States	Novartis Investigative Site	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy, 

References & Publications (1)

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, F — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Modified Abnormal Involuntary Movement Scale (mAIMS)score	Dyskinesia with a maximal score of 24.	Baseline, Day 28
Primary	Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Part III score	Anti-parkinsonian effect in PD patients.	Baseline, Day 28
Primary	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	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
Secondary	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
Secondary	Track-PD	Objective measures of motor function.	Up to Day 42
Secondary	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
Secondary	Area under the curve (AUC[0-24hr]) of AQW051		Day 28

External Links

•   Results for CAQW051A2209 from the Novartis Clinical Trials Website