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

NCT00291733 | Unknown Phase 2

• 1 other identifier: VALID-PD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Levodopa Induced Dyskinesia

Keywords

Levetiracetam; Levodopa-induced dyskinesias; Parkinson's

Outcome Measures

Primary Outcomes (1)

• Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries

  24 hours

Secondary Outcomes (1)

• 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

Study Arms (4)

1

ACTIVE COMPARATOR

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

Drug: Levetiracetam

2

PLACEBO COMPARATOR

placebo

Drug: Placebo

3

ACTIVE COMPARATOR

After crossover arm 3 equals arm 1

Drug: Levetiracetam

4

PLACEBO COMPARATOR

After crossover arm 4 equals arm 2

Drug: Placebo

Interventions

Levetiracetam DRUG

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

1; 3

Placebo DRUG

Placebo tabl

2; 4

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• 1st Hospital of Social Security Services: lead
• UCB Pharma: collaborator

Study Sites (1)

Department of Neurology, 1st Hospital of Social Security Services

Athens, 151-27, Greece

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pantelis Stathis, MD

  1st Hospital of Social Security Services

  STUDY CHAIR

• Spiros Konitsiotis, MD

  Department of Neurology, University of Ioannina

  PRINCIPAL INVESTIGATOR

• Vasilis Kyriakakis, MD

  Department of Neurology, General Hospital of Lamia

  PRINCIPAL INVESTIGATOR

• Georgios Tagaris, MD

  Department of Neurology, PGNA "Georgios Genimatas"

  PRINCIPAL INVESTIGATOR

• Kostas Papadopoulos, MD

  Department of Neurology, Hospital of Mental Diseases of Tripolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: May 1, 2006
• Study Completion: October 1, 2007
• Last Updated: November 15, 2007

Record last verified: 2007-11

Locations

GR (1)