Status:
TERMINATED
A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.
Lead Sponsor:
Abbott Products
Conditions:
Advanced Stage Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.
Detailed Description
Approximately 44 patients are to be randomized in a 3:1 ratio to two possible treatment groups, pardoprunox and pramipexole, respectively. The first part of the study will be blinded and consists of a...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients who have signed informed consent
- Diagnosis of idiopathic Parkinson's Disease
- Stable treatment with L-dopa and dopamine agonist for at least 28 days prior to randomization
- Presence of a recognizable ON and OFF state (motor fluctuations)
- Minimum hours of OFF-time per day of 1.5 hours (during waking hours including early morning akinesia) as recorded per baseline diaries
- Minimum hours of ON time with troublesome dyskinesia of 2 hours (during waking hours) as recorded per baseline diaries
- Prevalent expression of severely disabling dyskinesias during the waking day, i.e. dyskinesias are present at least 25% of the waking hours (UPDRS Part 4 item 32 \>= 2) in combination with a degree of disability which is moderate or higher (UPDRS Part 4 item 33 \>=2)
- Exclusion Criteria
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes
- Patients who have undergone surgery for the treatment of PD
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00903838
Start Date
September 1 2009
End Date
May 1 2011
Last Update
August 26 2011
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Site Reference ID/Investigator# 45433
Göttingen, Germany, 37075
2
Site Reference ID/Investigator# 45428
Kassel, Germany, 34128
3
Site Reference ID/Investigator# 45422
Tübingen, Germany, BW 72076
4
Site Reference ID/Investigator# 45427
Ulm, Germany, 89081