Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

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).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Dyskinesia, Drug-Induced Dyskinesias Levodopa Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neurotoxicity Syndromes Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Poisoning Signs and Symptoms Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Heidelberg, Victoria, Australia

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 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

Treatment and study plan

AFQ056

Drug

Primary outcomes

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

Secondary outcomes

Assessment of dyskinetic symptoms by change from baseline in mAIMS total score

Time frame: 3.5 years
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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Aug 2, 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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