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

• Sponsor: University of Turku (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00639119
• Collaborator: (none)
• Enrollment: 16
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unverricht-Lundborg Syndrome	Drug: Ropinirole	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
• Study Start Date: Aug 1, 2007
• Anticipated Primary Completion Date: Aug 1, 2008

Outcome Measures

Primary Outcome Measures

1. Unified myoclonus rating scale [3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Unverricht-Lundborg Syndrome

Exclusion Criteria:

• Pregnancy

• Intolerability to ropinirole hydrochloride

• Mental illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turku university central hospital, Department of neurology	Turku		Finland	20520

Sponsors and Collaborators

• University of Turku

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00639119
• Other Study ID Numbers: ERPME01
• First Posted: Mar 19, 2008
• Last Update Posted: Mar 19, 2008
• Last Verified: Feb 1, 2008

• Additional relevant MeSH terms: Epilepsy; Epilepsies, Myoclonic; Myoclonic Epilepsies, Progressive; Unverricht-Lundborg Syndrome; Ropinirole

Study Results

No Results Posted as of Mar 19, 2008