Status:
COMPLETED
Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias
Lead Sponsor:
UCB Pharma
Conditions:
Idiopathic Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
This is a 41-week trial composed of two consecutive parts (Part A, 14 weeks and optional Part B, 27 weeks) to evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adul...
Eligibility Criteria
Inclusion
- Male / female adult, 30 years old or more;
- Subject suffering from Idiopathic Parkinson's Disease, diagnosed according to the UK Brain Bank Criteria (see Appendix 14.8) (1) , since a minimum of 3 years, and stabilized with regard to the motor function (ratio .on./.off. over the day);
- Subject treated with levodopa whether or not combined with any other antiparkinsonian drugs (except apomorphine) for minimum one year;
- Subject experiencing during .on. periods, despite several attempts of treatment adjustment, persistent troublesome dyskinesias:
- with a minimum score of 2 on item 33 of the UPDRS-Part IV (moderately disabling dyskinesias);
- with a minimum score of 2 on item 32 of the UPDRS-Part IV (dyskinesias present during more than 25% of the waking day).
Exclusion
- Dyskinesias that cannot reliably be characterized on a regular basis by the subject himself/herself (more than 5 .errors. on DRC per 24 hours after repeated training);
- Subject currently treated with apomorphine or neuroleptic drugs either typical or atypical such as clozapine, olanzapine or risperidone;
- Subject currently treated with dopamine antagonists such as but not limited to metoclopramide, alizapride or phenothiazine derivatives (e.g. metopimazine). If necessary, the use of the dopamine antagonist domperidone is allowed.
- Subject Who had undergone or who was scheduled for functional neurosurgery for Parkinson's disease during the trial period;
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00160576
Start Date
July 1 2003
End Date
November 1 2004
Last Update
December 6 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.