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Completed

NCT Number: NCT01092065

Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia

This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias 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

The Parkinsons Institute, Sunnyvale, California, United States

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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 OFF time and dyskinesias for at least three months

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

Treatment and study plan

AFQ056 with L-dopa

Drug

hard gelatin capsule to be taken bid for six weeks

Placebo

Drug

hard gelatin capsule to be taken bid for six weeks

Primary outcomes

  1. Change from baseline to the last-observation-carried-forward (LOCF) endpoint at week 5 in total OFF time collected from the Hauser et al. patient diary

    Time frame: 5 weeks

Secondary outcomes

  1. Change from baseline to the LOCF endpoint at week 5 in ON time with dyskinesia collected from the Hauser et al. patient diary.

    Time frame: 5 weeks

  2. Effect of increasing L-dopa doses on the underlying symptoms of Parkinson's Disease (PD) as measured by the United Parkinson's Disease Rating Scale (UPDRS) Part III.

    Time frame: 5 weeks

  3. Change in dyskinesia from baseline to the LOCF endpoint at week 5 as measured by the modified Abnormal Involuntary Movement Scale (AIMS), patient diary and Unified Dyskinesia Rating Scale (UDysRS) Parts I-IV.

    Time frame: 5 weeks

  4. Change from baseline on patient's dyskinesia, disability caused by dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change.

    Time frame: 5 weeks

  5. Safety and tolerability as measured by changes in vital signs, laboratory values, ECGs, and percentages of treatment-emergent AEs and SAEs

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced Dyskinesia

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2010
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.

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