Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease

Parkinson's Disease Clinical Trial

— LeLeDys  

Official title:

Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307450
• Other study ID #: TUD-LELEDY-007
• Secondary ID: Ethic board no.:
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2006
• Last updated: July 31, 2009
• Start date: March 2006
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.

Description:

The LeLeDys study is designed to determine the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in advanced Parkinson's disease.

The design is a multicenter, randomized, stratified, double-blinded, placebo-controlled phase IV study design.

The hypothesis is that levetiracetam is able to reduce duration and severity of levodopa-induced dyskinesias in Parkinson's disease.

The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.

Main inclusion criteria are:

• Advanced Parkinson's disease (Hoehn & Yahr II-IV)

• Age of 30 to 80 years

• Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability

• Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion

• Written informed consent

Main exclusion criteria are:

• Atypical parkinsonian syndromes

• Treatment with antipsychotics

• Epilepsia or seizure in the history

• Deep brain stimulation other than DBS in STN

• Pregnant or lactating women

• Severe dementia

Methods:

• Primary outcome measure is the modified AIMS

• Secondary outcome measures include UPDRS, safety, patient day record

Study medication:

• Levetiracetam (upt to 2000 mg / day)

• Matched Placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Advanced Parkinson's disease (Hoehn & Yahr II-IV)

• Age of 30 to 80 years

• Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability

• Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion

• Written informed consent

Exclusion Criteria:

• Atypical parkinsonian syndromes

• Treatment with antipsychotics

• Epilepsia or seizure in the history

• Deep brain stimulation other than DBS in STN

• Pregnant or lactating women

• Severe dementia

Study Design

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

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Levetiracetam
up to 200 mg per day in two dosages per day.

Locations

Country	Name	City	State
Germany	Department of Neurology at the Technical University of Dresden	Dresden
Germany	Department of Neurology at the University of Leipzig	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	UCB Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified AIMS		11 weeks	No
Primary	UPDRS items 32 & 33		11 weeks	No
Secondary	UPDRS		11 weeks	No
Secondary	Schwab & England scale		11 weeks	No
Secondary	Hoehn & Yahr scale		11 weeks	No
Secondary	GCI		11 weeks	No
Secondary	Patient day record		11 weeks	No
Secondary	Epsworth sleep scale		11 weeks	Yes
Secondary	Levodopa challenge test		11 weeks	No
Secondary	Safety measures		11 weeks	Yes

External Links

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