MedDataX Logo

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

NCT ID: NCT00291733

Last Updated: 2007-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Levodopa Induced Dyskinesia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Levetiracetam Levodopa-induced dyskinesias Parkinson's

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

500mg levetiracetam for one week and 1000mg levetiracetam for one week

Group Type ACTIVE_COMPARATOR

Levetiracetam

Intervention Type DRUG

500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week

2

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tabl

3

After crossover arm 3 equals arm 1

Group Type ACTIVE_COMPARATOR

Levetiracetam

Intervention Type DRUG

500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week

4

After crossover arm 4 equals arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tabl

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levetiracetam

500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week

Intervention Type DRUG

Placebo

Placebo tabl

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank.


* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UCB Pharma

INDUSTRY

Sponsor Role collaborator

1st Hospital of Social Security Services

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pantelis Stathis, MD

Role: STUDY_CHAIR

1st Hospital of Social Security Services

Spiros Konitsiotis, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Ioannina

Vasilis Kyriakakis, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, General Hospital of Lamia

Georgios Tagaris, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, PGNA "Georgios Genimatas"

Kostas Papadopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Hospital of Mental Diseases of Tripolis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Neurology, 1st Hospital of Social Security Services

Athens, , Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VALID-PD

Identifier Type: -

Identifier Source: org_study_id