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

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ClinicalTrials.gov Identifier: NCT01023282
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Tolerability Drug: ACR325 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023282


Locations
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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

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Responsible Party: NeuroSearch A/S
ClinicalTrials.gov Identifier: NCT01023282     History of Changes
Other Study ID Numbers: ACR325C005
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: June 2011

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

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs