Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients
Sponsor
NeuroSearch A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01023282
Collaborator
(none)
22
2
2
17
11
0.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
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
:
Nov 1, 2009
Actual Primary Completion Date
:
Apr 1, 2011
Actual Study Completion Date
:
Apr 1, 2011
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerability [4 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Paracelsus-Elena-Klinik | Kassel | Hessen | Germany | D-34128 |
| 2 | Klinik für Neurologie, Philipps-Universität Marburg | Marburg | Hessen | Germany | D-35039 |
Sponsors and Collaborators
- NeuroSearch A/S
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
NeuroSearch A/S
ClinicalTrials.gov Identifier:
NCT01023282
Other Study ID Numbers:
- ACR325C005
First Posted:
Dec 2, 2009
Last Update Posted:
Nov 2, 2011
Last Verified:
Jun 1, 2011
Keywords provided by NeuroSearch A/S
Additional relevant MeSH terms: