Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients
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ClinicalTrials.gov Identifier: NCT00888004 |
Recruitment Status
:
Completed
First Posted
: April 24, 2009
Last Update Posted
: April 19, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease L-dopa Induced Dyskinesia | Drug: AFQ056 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | March 2009 |
Actual Primary Completion Date : | August 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Active | Drug: AFQ056 |
Placebo Comparator: Placebo | Drug: Placebo |
- Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa [ Time Frame: 20 days ]
- Safety and tolerability of administration of AFQ056 in combination with L-dopa [ Time Frame: 20 days ]

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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 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

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 ClinicalTrials.gov identifier (NCT number): NCT00888004
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT00888004 History of Changes |
Other Study ID Numbers: |
CAFQ056A2206 2008-006270-15 |
First Posted: | April 24, 2009 Key Record Dates |
Last Update Posted: | April 19, 2016 |
Last Verified: | April 2016 |
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 |