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Trial record 1 of 6 for:    "progressive myoclonus epilepsy with ataxia" OR "Myoclonic Epilepsies, Progressive"
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Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by University of Turku.
Recruitment status was:  Enrolling by invitation
ClinicalTrials.gov Identifier:
First Posted: March 19, 2008
Last Update Posted: March 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Turku

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
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

Resource links provided by NLM:

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Unified myoclonus rating scale [ Time Frame: 3 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639119

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

Responsible Party: Matti Karvonen, MD, PhD, Department of Neurology, Turku University Hospital
ClinicalTrials.gov Identifier: NCT00639119     History of Changes
Other Study ID Numbers: ERPME01
First Submitted: February 28, 2008
First Posted: March 19, 2008
Last Update Posted: March 19, 2008
Last Verified: February 2008

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