Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type

Phase 2

• Conditions: Unverricht-Lundborg Syndrome

• Registration Number: NCT00639119
• Lead Sponsor: University of Turku

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Status Verified: 2008-02
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-18
• Last Update Submitted: 2008-03-18
• Study First Posted: 2008-03-19
• Last Update Posted: 2008-03-19
• Primary Completion: 2008-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Unverricht-Lundborg Syndrome

Read More

Exclusion Criteria

• Pregnancy
• Intolerability to ropinirole hydrochloride
• Mental illness

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Unified myoclonus rating scale	3

Trial Locations

Locations (1)

Turku university central hospital, Department of neurology; 🇫🇮 Turku, Finland