Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
Primary Purpose
Unverricht-Lundborg Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Ropinirole
Sponsored by
About this trial
This is an interventional treatment trial for Unverricht-Lundborg Syndrome
Eligibility Criteria
Inclusion Criteria:
- Unverricht-Lundborg Syndrome
Exclusion Criteria:
- Pregnancy
- Intolerability to ropinirole hydrochloride
- Mental illness
Sites / Locations
- Turku university central hospital, Department of neurology
Outcomes
Primary Outcome Measures
Unified myoclonus rating scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00639119
Brief Title
Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
Official Title
Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Turku
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unverricht-Lundborg Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ropinirole
Intervention Description
8 + 8 weeks cross-over placebo controlled
Primary Outcome Measure Information:
Title
Unified myoclonus rating scale
Time Frame
3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unverricht-Lundborg Syndrome
Exclusion Criteria:
Pregnancy
Intolerability to ropinirole hydrochloride
Mental illness
Facility Information:
Facility Name
Turku university central hospital, Department of neurology
City
Turku
ZIP/Postal Code
20520
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
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