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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003210-33-FI

Enrollment

Registered

2007-06-13

Start date

2007-08-03

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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 Objective: To investigate the efficacy of add-on dopaminergic medication (ropininirole hydrochloride) on electrophysiological determinants on disease activity (EEG and sensory evoked potentials);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.	—

Measure

Time frame

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

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026