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

November 1, 2011 updated by: NeuroSearch A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Kassel, Hessen, Germany, D-34128
        • Paracelsus-Elena-Klinik
      • Marburg, Hessen, Germany, D-35039
        • Klinik für Neurologie, Philipps-Universität Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: ACR325
Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks
Drug: Placebo
Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks
Experimental: ACR325
Drug: ACR325
Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroSearch A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACR325C005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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