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| Sponsored by: |
University of Turku |
| Information provided by: | University of Turku |
| ClinicalTrials.gov Identifier: | NCT00639119 |
Purpose
The progressive myoclonus epilepsy of the Unverricht-Lundborg disease (ULD) type is an autosomal recessive disease characterized by progressive stimulus-sensitive and action-related myoclonic jerks.
The mainstay of the current treatment in myoclonic epilepsies including ULD are valproic acid and clonazepam among several other antiepileptic drugs. Unfortunately the disease may often be resistant to antiepileptic drugs leading to major reductions in daily activities and disability to walk without assistance. Therefore new treatment modalities are needed. Experimental treatments of ULD patients with dopamine agonists have relieved myoclonic symptoms. Further, in accordance with this, a recent study indicates decreased dopaminergic neurotransmission in the basal ganglia of ULD patients, determined by PET.
The purpose of this study is to investigate the effect of dopaminergic medication (ropinirole hydrochloride, Requip ®) on relieving the symptoms of ULD patients. Patients will undergo sixteen weeks intervention period. The main efficacy determinants are changes in unified myoclonus rating scale (UMRS), nerve conduction, multi-modality evoked potentials including visual evoked potential (VEP), somatosensory evoked potential (SSEP) and brainstem auditory evoked potential (BAEP), blink reflex habituation and electroencephalography (EEG). Tolerability and the safety of the medication are determined. The study setting is placebo controlled, crossover, two-group and double blind study.
| Condition | Intervention | Phase |
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Unverricht-Lundborg Syndrome |
Drug: Ropinirole |
Phase II |
| Genetics Home Reference related topics: | familial encephalopathy with neuroserpin inclusion bodies pyridoxal 5'-phosphate-dependent epilepsy Unverricht-Lundborg disease |
| MedlinePlus related topics: | Epilepsy |
| ChemIDplus related topics: | Ropinirole Ropinirole hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type |
| Estimated Enrollment: | 16 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Department of Neurology, Turku University Hospital ( Matti Karvonen, MD, PhD ) |
| Study ID Numbers: | ERPME01 |
| First Received: | February 28, 2008 |
| Last Updated: | March 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00639119 |
| Health Authority: | Finland: National Agency for Medicines |
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