Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
NCT ID: NCT00639119
Last Updated: 2008-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
16 participants
INTERVENTIONAL
2007-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Interventions
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Ropinirole
8 + 8 weeks cross-over placebo controlled
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Intolerability to ropinirole hydrochloride
* Mental illness
18 Years
70 Years
ALL
No
Sponsors
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University of Turku
OTHER
Responsible Party
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Department of Neurology, Turku University Hospital
Locations
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Turku university central hospital, Department of neurology
Turku, , Finland
Countries
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Other Identifiers
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ERPME01
Identifier Type: -
Identifier Source: org_study_id