Back to resultsSafety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients
Primary Purpose
Parkinson's Disease, Tolerability
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
ACR325
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Levodopa, Dyskinesia, ACR325
Eligibility 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
Sites / Locations
- Paracelsus-Elena-Klinik
- Klinik für Neurologie, Philipps-Universität Marburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ACR325
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01023282
Brief Title
Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroSearch A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate the safety and tolerability of ACR325 in Parkinson disease patients and evaluate the effect on levodopa induced dyskinesias.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Tolerability
Keywords
Parkinson's disease, Levodopa, Dyskinesia, ACR325
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACR325
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ACR325
Intervention Description
Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules, dose titration from 25 mg to 75 mg bid or matching placebo. Duration of dosing: 3 weeks
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Paracelsus-Elena-Klinik
City
Kassel
State/Province
Hessen
ZIP/Postal Code
D-34128
Country
Germany
Facility Name
Klinik für Neurologie, Philipps-Universität Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
D-35039
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients
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