This trial is active, not recruiting.

Condition levodopa induced dyskinesia
Treatments levetiracetam, placebo
Phase phase 2
Sponsor 1st Hospital of Social Security Services
Collaborator UCB, Inc.
Start date May 2006
End date October 2007
Trial size 50 participants
Trial identifier NCT00291733, VALID-PD


Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge characteristics of basal ganglia. From the other hand, LEV which shares a different electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of abnormal neuronal firing in experimental models of epilepsy. LEV also reduces levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates "priming phenomenon" which associated with long-term changes in synaptic function that can lead to dyskinesias in PD.

Study objectives :

- To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo on disabling dyskinesias that develop as result of long-term treatment with levodopa, occurring at the time of maximal clinical improvement in patients with Parkinson's disease (PD).

- To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
500mg levetiracetam for one week and 1000mg levetiracetam for one week
500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week
(Placebo Comparator)
Placebo tabl
(Active Comparator)
After crossover arm 3 equals arm 1
500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week
(Placebo Comparator)
After crossover arm 4 equals arm 2
Placebo tabl

Primary Outcomes

Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries
time frame: 24 hours

Secondary Outcomes

Percent change of "on without dyskinesias" and "off" time from patient diaries. Changes in severity and duration of LID according to the UPDRS , Schwab & England scale and also Goetz dyskinesia scale after a levodopa challenge dose.
time frame: 24 hours

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

Inclusion Criteria: Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank. Other inclusion criteria: - Patients between ages 30 and 80 - Hoehn and Yahr stage of PD over IIb - Levodopa-induced dyskinesias (LID) despite optimization of antiparkinsonian medication - LID severity 2 on item 32 and duration 2 on item 33 of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV - Patient is willing to adhere to protocol requirements as evidence by written informed consent Exclusion Criteria: - Patient has a history of any medical condition or clinically significant laboratory abnormalities that can subject them to unwarranted risk. - Female patient is pregnant or breastfeeding or has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal. - Patient with ablative surgeries or DBS implantation electrodes for diseases of the basal ganglia. - Patient has a low Mini-mental Examination MMSE score <25 or has a history of bipolar psychosis or schizophrenia. - Patient is unwilling to sign an informed consent or to comply with protocol requirements. - Patient is taking or has taken in the past month amantadine.

Additional Information

Official title Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial
Principal investigator Spiros Konitsiotis, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2007.
Information provided to ClinicalTrials.gov by 1st Hospital of Social Security Services.