Clinical trial NCT00291733: Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease
Official title: Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Levodopa Induced Dyskinesia
Keywords: Levetiracetam
Levodopa-induced dyskinesias
Parkinson's
Lead sponsor: 1st Hospital of Social Security Services
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2006-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries
timeFrame: 24 hours
Secondary outcomes:
measure: 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.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Neurology, 1st Hospital of Social Security Services
Study officials:
affiliation: 1st Hospital of Social Security Services
name: Pantelis Stathis, MD
role: STUDY_CHAIR
affiliation: Department of Neurology, University of Ioannina
name: Spiros Konitsiotis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, General Hospital of Lamia
name: Vasilis Kyriakakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, PGNA "Georgios Genimatas"
name: Georgios Tagaris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, Hospital of Mental Diseases of Tripolis
name: Kostas Papadopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: