Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01173731
First received: July 28, 2010
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease Dyskinesia, Drug-Induced Levodopa |
Drug: AFQ056 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias |
Resource links provided by NLM:
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:
- Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC). [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assessment of dyskinetic symptoms by change from baseline in mAIMS total score [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
- Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
| Enrollment: | 67 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AFQ056 | Drug: AFQ056 |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.
Exclusion Criteria:
- Surgical treatment for PD
- Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
- Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173731
Locations
| United States, California | |
| Novartis Investigative Site | |
| Sunnyvale, California, United States, 94089 | |
| United States, Colorado | |
| Novartis Investigative Site | |
| Englewood, Colorado, United States, 80113 | |
| United States, Indiana | |
| Novartis Investigative Site | |
| Indianapolis, Indiana, United States, 46202 | |
| Australia, Victoria | |
| Novartis Investigative Site | |
| Heidelberg, Victoria, Australia, 3081 | |
| Novartis Investigative Site | |
| Parkville, Victoria, Australia, 3050 | |
| Novartis Investigative Site | |
| Prahran, Victoria, Australia, 3181 | |
| Canada, Ontario | |
| Novartis Investigative Site | |
| Ottawa, Ontario, Canada, K1G 4G3 | |
| Canada, Quebec | |
| Novartis Investigative Site | |
| Gatineau, Quebec, Canada, J9J 0A5 | |
| Novartis Investigative Site | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| France | |
| Novartis Investigative Site | |
| Clermont-Ferrand Cedex 1, France, 63003 | |
| Novartis Investigative Site | |
| Lille Cedex, France, 59037 | |
| Novartis Investigative Site | |
| Pessac, France, 33604 | |
| Germany | |
| Novartis Investigative Site | |
| Bochum, Germany, 44791 | |
| Novartis Investigative Site | |
| Dresden, Germany, 01307 | |
| Novartis Investigative Site | |
| Kassel, Germany, 34128 | |
| Novartis Investigative Site | |
| Marburg, Germany, 35039 | |
| Novartis Investigative Site | |
| Muenchen, Germany, 80804 | |
| Novartis Investigative Site | |
| Stadtroda, Germany, 07646 | |
| Novartis Investigative Site | |
| Tuebingen, Germany, 72076 | |
| Italy | |
| Novartis Investigative Site | |
| Lido di Camaiore, LU, Italy, 55041 | |
| Novartis Investigative Site | |
| Roma, RM, Italy, 00163 | |
| Novartis Investigative Site | |
| Napoli, Italy, 80131 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01173731 History of Changes |
| Other Study ID Numbers: | CAFQ056A2217, 2010-019418-25 |
| Study First Received: | July 28, 2010 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Therapeutic Products Directorate (TPD) Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: Agenzia Italiana del Farmaco (AIFA) |
Keywords provided by Novartis:
|
Parkinson Disease L-dopa Levodopa |
Dyskinesia involuntary movement motor complication |
Additional relevant MeSH terms:
|
Dyskinesias Dyskinesia, Drug-Induced Parkinson Disease Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Neurotoxicity Syndromes Drug Toxicity Poisoning Substance-Related Disorders Parkinsonian Disorders |
Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases Levodopa Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013