Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease

Levodopa Induced Dyskinesia Clinical Trial

Official title:

Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00291733
• Other study ID #: VALID-PD
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 14, 2006
• Last updated: November 14, 2007
• Start date: May 2006
• Est. completion date: October 2007

Study information

• Verified date: November 2007
• Source: 1st Hospital of Social Security Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Levodopa Induced Dyskinesia
• Parkinson Disease

Intervention

Drug:
• Levetiracetam
500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week
• Placebo
Placebo tabl

Locations

Country	Name	City	State
Greece	Department of Neurology, 1st Hospital of Social Security Services	Athens

Sponsors (2)

Lead Sponsor	Collaborator
1st Hospital of Social Security Services	UCB Pharma

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries		24 hours
Secondary	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.		24 hours