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

Purpose

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of administration of AFQ056 in combination with L-dopa [ Time Frame: 20 days ] [ Designated as safety issue: Yes ]


Enrollment:	28
Study Start Date:	March 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active	Drug: AFQ056
Placebo Comparator: Placebo	Drug: Placebo

Eligibility


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

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888004

Locations


Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Kassel, Germany
Novartis Investigative Site
Leun-Biskirchen, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Tubingen, Germany

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Berg D, Godau J, Trenkwalder C, Eggert K, Csoti I, Storch A, Huber H, Morelli-Canelo M, Stamelou M, Ries V, Wolz M, Schneider C, Di Paolo T, Gasparini F, Hariry S, Vandemeulebroecke M, Abi-Saab W, Cooke K, Johns D, Gomez-Mancilla B. AFQ056 treatment of levodopa-induced dyskinesias: results of 2 randomized controlled trials. Mov Disord. 2011 Jun;26(7):1243-50. doi: 10.1002/mds.23616. Epub 2011 Apr 11.


Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00888004 History of Changes
Other Study ID Numbers:	CAFQ056A2206 2008-006270-15
Study First Received:	April 23, 2009
Last Updated:	April 15, 2016
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:


Parkinson's L-dopa dyskinesia

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 29, 2016