To assess the efficacy as well as the safety and tolerability of an investigational drug called UCB0942 that will be given in addition to the current epilepsy treatment of the patient.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
75% responder rate (75%RR: proportion of subjects with a 75% or greater
reduction in focal seizure frequency during Treatment Period compared to
Baseline Period)
Secondary outcome
- pharmacokinetics,
- safety and
-50% responder rate (50%RR), median % seizure reduction from baseline, partial
seizure frequency, seizure freedom and seizure free days, SSQ, and QOLIE-31-P
Background summary
UCB0942 is a medicinal product which is currently being evaluated as an
antiepileptic drug in clinical studies. It has not yet been approved by the
authorities for the treatment of any disease, including focal epilepsy. Studies
in animals suggest that UCB0942 may have anti-seizure effects in humans.
Study objective
To assess the efficacy as well as the safety and tolerability of an
investigational drug called UCB0942 that will be given in addition to the
current epilepsy treatment of the patient.
Study design
A Phase 2A, double-blind, randomized, placebo-controlled, multi-center study
that will test the potential efficacy, safety/tolerability, and PK profile of
UCB0942 in adult patients with highly drug-resistant focal epilepsy. UCB0942
400mg bid will be administered as add-on to each patient*s concomitant AED
regimen.
Subjects with highly drug-resistant focal epilepsy will be enrolled at up to 10
European sites in order to provide 46 evaluable subjects
Intervention
Test treatment: 1 week titration to 400mg UCB0942 bid (Days T1 to T7) followed
by 10 weeks on 400mg UCB0942 bid during Inpatient (2 weeks, double-blind) and
Outpatient Maintenance Period (8 weeks open label). For Subjects not continuing
in the Open Label Extension (OLE) study, dose will be tapered over 2 weeks(Days
TOO1 to TOO14)
Reference treatment: 2 weeks placebo matching 400mg UCB0942 bid, then titration
to 400mg UCB0942 bid during Days TTO1 to TTO7) followed by 8 weeks on 400mg
UCB0942 bid during Outpatient Maintenance Period (8 week open label). For
Subjects not continuing in the OLE study, dose will be tapered over 2
weeks(Days TOO1 to TOO14)
Study burden and risks
- For this study a canula will be inserted. This can be a minor discomfort. In
some cases bruise can develop.
- ECGs: There may be minor discomfort with these assessments, similar to
removing a bandage, when the electrodes taped to the skin are removed. Rarely,
a reaction to the electrode adhesive may cause redness or itching of the skin.
Allée de la Recherche 60
Brussels B-1070
BE
Allée de la Recherche 60
Brussels B-1070
BE
Listed location countries
Age
Inclusion criteria
Age *18 years
BMI Between 16.0 and 40.0 kg/m2
Pathology - Subject is diagnosed with focal epilepsy
- Subject has failed to achieve adequate seizure control with *4 appropriately chosen AED regimens of adequate dose and duration, including the current treatment
Exclusion criteria
- Subject has a current or past psychiatric condition that, in the opinion of the Investigator, could compromise his/her safety or ability to participate in this study.
- Subject has a history of status epilepticus or has been hospitalized for status epilepticus within the 6-month period prior to Screening Visit.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201400333012-NL |
| CCMO | NL53484.056.15 |