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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00639119
First received: February 28, 2008
Last updated: March 18, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Unverricht-Lundborg Syndrome
Drug: Ropinirole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type

Resource links provided by NLM:


Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Unified myoclonus rating scale [ Time Frame: 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: August 2007
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ropinirole
    8 + 8 weeks cross-over placebo controlled
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unverricht-Lundborg Syndrome

Exclusion Criteria:

  • Pregnancy
  • Intolerability to ropinirole hydrochloride
  • Mental illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639119

Locations
Finland
Turku university central hospital, Department of neurology
Turku, Finland, 20520
Sponsors and Collaborators
University of Turku
  More Information

No publications provided

Responsible Party: Matti Karvonen, MD, PhD, Department of Neurology, Turku University Hospital
ClinicalTrials.gov Identifier: NCT00639119     History of Changes
Other Study ID Numbers: ERPME01
Study First Received: February 28, 2008
Last Updated: March 18, 2008
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Myoclonic
Myoclonic Epilepsies, Progressive
Unverricht-Lundborg Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014