Skip to main content
OpenTrials
Completed

NCT Number: NCT01385592

Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyskinesias Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
  • Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks

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) or evidence of dementia that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

AFQ056

Drug

Placebo

Drug

Primary outcomes

  1. Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile

    Time frame: 12 weeks

Secondary outcomes

  1. Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)

    Time frame: 12 weeks

  2. Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)

    Time frame: 12 weeks

  3. Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)

    Time frame: 12 weeks

  4. Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS )

    Time frame: 12 weeks

  5. Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2011
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.