Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
Information source: University of Turku
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unverricht-Lundborg Syndrome
Intervention: Ropinirole (Drug)
Phase: Phase 2
Status: Enrolling by invitation
Sponsored by: University of Turku
Summary
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.
Clinical Details
Official title: Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Unified myoclonus rating scale
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Unverricht-Lundborg Syndrome
Exclusion Criteria:
- Pregnancy
- Intolerability to ropinirole hydrochloride
- Mental illness
Locations and Contacts
Turku university central hospital, Department of neurology, Turku 20520, Finland
Additional Information
Starting date: August 2007
Last updated: March 18, 2008
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