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Sponsors and Collaborators: |
Dresden University of Technology UCB GmbH, Huettenstrasse 205, 50170 Kerpen, Germany |
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Information provided by: | Dresden University of Technology |
ClinicalTrials.gov Identifier: | NCT00307450 |
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.
Condition | Intervention | Phase |
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Parkinson's Disease |
Drug: Levetiracetam |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-Induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Monocenter, Randomized, Stratified, Double-Blinded, Placebo-Controlled Phase IV Study |
Estimated Enrollment: | 44 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | August 2008 |
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 monocenter, 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:
Main exclusion criteria are:
Methods:
Study medication:
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexander Storch, MD | ++49-351-458 ext 2532 | alexander.storch@neuro.med.tu-dresden.de |
Contact: Martin Wolz, MD | ++49-351-458 ext 3886 | martin.wolz@neuro.med.tu-dresden.de |
Germany | |
Department of Neurology at the Technical University of Dresden | Recruiting |
Dresden, Germany, 01307 | |
Contact: Alexander Storch, MD ++49-351-458 ext 2532^ alexander.storch@neuro.med.tu-dresden.de | |
Contact: Martin Wolz, MD ++49-351-458 ext 3886 martin.wolz@neuro.med.tu-dresden.de | |
Sub-Investigator: Martin Wolz, MD |
Principal Investigator: | Alexander Storch, M | Technical University of Dresden |
Study ID Numbers: | TUD-LELEDY-007, Ethic board no.: EK10012006, EUDRAC no.: 2005-005940-18 |
Study First Received: | March 27, 2006 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00307450 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Dyskinesias Parkinson's disease Levetiracetam Treatment |
Levodopa Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias |
Signs and Symptoms Parkinson Disease Movement Disorders Piracetam Neurologic Manifestations Etiracetam Parkinsonian Disorders |
Nootropic Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |