Effect of ropinirole hydrochloride in progressive myoclonic epilepsy of Unverricht–Lundborg type

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-003210-33-FI
• Date of registration: 13/06/2007
• Prospective Registration: Yes
• Primary sponsor: Department of Neurology, Turku University Hospital
• Public title: Effect of ropinirole hydrochloride in progressive myoclonic epilepsy of Unverricht–Lundborg type
• Scientific title: Effect of ropinirole hydrochloride in progressive myoclonic epilepsy of Unverricht–Lundborg type
• Date of first enrolment: 03/08/2007
• Target sample size: 15
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003210-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Finland

Key inclusion & exclusion criteria

Inclusion criteria:
1) ULD diagnosed by an experienced neurologist, and confirmed with molecular diagnostics
2) Stimulus-activated myoclonus as the most prominent symptom of ULD
3) Age 18-60 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Current medicated psychiatric disorder
2) Previous severe head trauma
3) History of alcohol/substance abuse
4) Pregnancy or lactation
5) Known hypersensitivity to ropinirole hydrochloride or to other ingredients of the product
6) Concomitant participation in another drug study
7) Severe renal or hepatic insufficiency



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Progressive myoclonus epilepsy of the Unverricht–Lundborg disease (ULD) type
MedDRA version: 9.1 Level: PT Classification code 10054895 Term: Baltic myoclonic epilepsy

Intervention(s)

Trade Name: Requip
Product Name: Ropinirole hydrochloride
Pharmaceutical Form: Tablet
CAS Number: 91374208
Other descriptive name: ROPINIROLE HYDROCHLORIDE
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Clinical assessments/endpoints
Unified myoclonus rating scale (UMRS) is the main clinical assessment of the efficacy of the ropinirole hydrochloride in the study on myoclonus severity and overall disability. UMRS questionnaire includes structural assessment sections on 1) patient questionnaire of myoclonus, 2) moclonus at rest, 3) stimulus sensitivity, 4) myoclonus with action, 5) functional tests, 6) global scores of disability, 7) presence of negative myoclonus and 8) severity of negative myoclonus.

Electrophysiological assessments/endpoints
The electrophysiological evaluation including nerve conduction, multi-modality evoked potentials including visual evoked potential (VEP), somatosensory evoked potential (SSEP) and brainstem auditory evoked potential (BAEP) and electroencephalography (EEG) will be determined and evaluated. All the electrophysiological evaluations are carried out using standard protocols.

Secondary Objective: To investigate the efficacy of add-on dopaminergic medication (ropininirole hydrochloride) on electrophysiological determinants on disease activity (EEG and sensory evoked potentials)

Main Objective: The primary objective of the current study is to investigate the efficacy and sarfety of add-on dopaminergic medication (ropininirole hydrochloride) on the symptoms of ULD, especially on myoclonic jerks and on general disability.

Secondary ID(s)

ERPME01