Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
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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 |
|---|---|---|
|
Unverricht-Lundborg Syndrome |
Drug: Ropinirole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type |
- Unified myoclonus rating scale [ Time Frame: 3 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
-
Drug: Ropinirole
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Unverricht-Lundborg Syndrome
Exclusion Criteria:
- Pregnancy
- Intolerability to ropinirole hydrochloride
- Mental illness
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00639119
| Finland | |
| Turku university central hospital, Department of neurology | |
| Turku, Finland, 20520 | |
More Information
| Responsible Party: | Matti Karvonen, MD, PhD, Department of Neurology, Turku University Hospital |
| ClinicalTrials.gov Identifier: | NCT00639119 History of Changes |
| Other Study ID Numbers: | ERPME01 |
| Study First Received: | February 28, 2008 |
| Last Updated: | March 18, 2008 |
| Health Authority: | Finland: Finnish Medicines Agency |
Additional relevant MeSH terms:
|
Epilepsy Unverricht-Lundborg Syndrome Epilepsies, Myoclonic Myoclonic Epilepsies, Progressive Brain Diseases Central Nervous System Diseases Nervous System Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases |
Genetic Diseases, Inborn Ropinirole Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016