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

Parkinson's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023282
• Other study ID #: ACR325C005
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2009
• Last updated: November 1, 2011
• Start date: November 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: NeuroSearch A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Tolerability

Intervention

Drug:
• ACR325
Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks
• Placebo
Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks

Locations

Country	Name	City	State
Germany	Paracelsus-Elena-Klinik	Kassel	Hessen
Germany	Klinik für Neurologie, Philipps-Universität Marburg	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
NeuroSearch A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		4 weeks	No