NCT Number: NCT00160576
Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias
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 adults with Idiopathic Parkinson's Disease, without negative impact on the benefit on the motor function of the antiparkinsonian treatment.
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Notify MeKey information
Conditions
Age range
30 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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;
Treatment and study plan
Primary outcomes
-
Evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease by assessing the reduction in mean duration of dyskinesias during "on" period at 10-week
Secondary outcomes
-
Reduction in mean duration of dyskinesias per day at 9 month;Safety
Sponsors and collaborators
Lead sponsor
UCB Pharma
Industry
Registry information
Official study title
A Therapeutic Exploratory, Single Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Levetiracetam up to 4000 mg/Day (500mg Oral Tablets) on Levodopa Induced Dyskinesias in Adults With Idiopathic Parkinson's Disease
Important dates
- Study start
- 2003
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Sep 12, 2005
- Registry last updated
- Dec 6, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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