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

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ClinicalTrials.gov Identifier: NCT00639119
Recruitment Status : Unknown
Verified February 2008 by University of Turku.
Recruitment status was:  Enrolling by invitation
First Posted : March 19, 2008
Last Update Posted : March 19, 2008
Sponsor:
Information provided by:
University of Turku

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2007
Estimated Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Intervention Details:
  • Drug: Ropinirole
    8 + 8 weeks cross-over placebo controlled

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unverricht-Lundborg Syndrome

Exclusion Criteria:

  • Pregnancy
  • Intolerability to ropinirole hydrochloride
  • Mental illness
Contacts and Locations
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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


Locations
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Finland
Turku university central hospital, Department of neurology
Turku, Finland, 20520
Sponsors and Collaborators
University of Turku
More Information
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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 Posted: March 19, 2008    Key Record Dates
Last Update Posted: March 19, 2008
Last Verified: February 2008
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Myoclonic
Myoclonic Epilepsies, Progressive
Unverricht-Lundborg Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
Epileptic Syndromes
Heredodegenerative Disorders, Nervous System
 Neurodegenerative Diseases
Genetic Diseases, Inborn
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs