Unverricht-Lundborg Syndrome Clinical Trial
Official title:
Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
| Verified date | February 2008 |
| Source | University of Turku |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Finland: Finnish Medicines Agency |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 16 |
| Est. completion date | |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Unverricht-Lundborg Syndrome Exclusion Criteria: - Pregnancy - Intolerability to ropinirole hydrochloride - Mental illness |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Finland | Turku university central hospital, Department of neurology | Turku |
| Lead Sponsor | Collaborator |
|---|---|
| University of Turku |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Unified myoclonus rating scale | 3 | No |