Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients

The study will evaluate the safety and tolerability of ACR325 in Parkinson disease patients and evaluate the effect on levodopa induced dyskinesias.

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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 Tolerability

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Paracelsus-Elena-Klinik, Kassel, Hesse, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of idiopathic Parkinson"s disease according to the United Kingdom Parkinson's Disease Society brain bank diagnostic criteria
Levodopa induced dyskinesia

Exclusion criteria

Previous surgery for Parkinson's disease
Any current or history of heart condition or increased pro-arrhythmic risk
Severe or ongoing unstable medical condition

Treatment and study plan

ACR325

Drug

Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks

Placebo

Drug

Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks

Primary outcomes

Safety and tolerability

Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

NeuroSearch A/S

Industry

Registry information

Official study title

Randomised, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ACR325 in Parkinson's Disease Patients, With Evaluation of the Effect on Levodopa Induced Dyskinesias as a Secondary Measure

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Dec 2, 2009
Registry last updated: Nov 2, 2011

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.

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

Completed