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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01173731
First received: July 28, 2010
Last updated: September 12, 2013
Last verified: September 2013
  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:


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: 66
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
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: 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: September 12, 2013
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-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
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 August 26, 2014