Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00888004

Collaborator

(none)

Enrollment

Locations

Arms

5.6

Patients Per Site

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease L-dopa Induced Dyskinesia	Drug: AFQ056 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced Dyskinesias

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active	Drug: AFQ056
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Active

Drug: AFQ056

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa [20 days]

Secondary Outcome Measures

Safety and tolerability of administration of AFQ056 in combination with L-dopa [20 days]

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 L-dopa induced dyskinesia for at least 3 months
Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum

Exclusion Criteria:

History of severe allergy to food or drugs
Very low or high body weight.
Prior surgery for Parkinson's Disease
Smokers Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Dresden	Germany
2	Novartis Investigative Site	Kassel	Germany
3	Novartis Investigative Site	Leun-Biskirchen	Germany
4	Novartis Investigative Site	Marburg	Germany
5	Novartis Investigative Site	Tubingen	Germany