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

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:

Genetics Home Reference related topics: PRICKLE1-related progressive myoclonus epilepsy with ataxia pyridoxal 5'-phosphate-dependent epilepsy Unverricht-Lundborg disease

MedlinePlus related topics: Epilepsy

Drug Information available for: Ropinirole hydrochloride Ropinirole

Genetic and Rare Diseases Information Center resources: Progressive Myoclonic Epilepsy Unverricht-Lundborg Disease

U.S. FDA Resources

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:

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:


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

ClinicalTrials.gov processed this record on March 02, 2015