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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeuroSearch A/S
ClinicalTrials.gov Identifier:
NCT01023282
First received: December 1, 2009
Last updated: November 1, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
Tolerability
 Drug: ACR325
Drug: Placebo
 Phase 1

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

Resource links provided by NLM:

Drug Information available for: Levodopa
U.S. FDA Resources

Further study details as provided by NeuroSearch A/S:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: November 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACR325 Drug: ACR325
Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks
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

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023282

Locations
Germany
Paracelsus-Elena-Klinik
Kassel, Hessen, Germany, D-34128
Klinik für Neurologie, Philipps-Universität Marburg
Marburg, Hessen, Germany, D-35039
Sponsors and Collaborators
NeuroSearch A/S
  More Information

No publications provided

Responsible Party: NeuroSearch A/S
ClinicalTrials.gov Identifier: NCT01023282     History of Changes
Other Study ID Numbers: ACR325C005
Study First Received: December 1, 2009
Last Updated: November 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by NeuroSearch A/S:
Parkinson's disease
Levodopa
Dyskinesia
ACR325

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 19, 2013