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

Phase 1

Completed

• Conditions: Tolerability; Parkinson's Disease
• Interventions: Drug: ACR325; Drug: Placebo

• Registration Number: NCT01023282
• Lead Sponsor: NeuroSearch A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACR325	ACR325	-
Placebo	ACR325	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	4 weeks

Trial Locations

Locations (2)

Paracelsus-Elena-Klinik; 🇩🇪 Kassel, Hessen, Germany

Klinik für Neurologie, Philipps-Universität Marburg; 🇩🇪 Marburg, Hessen, Germany