Trial to evaluate efficacy and safety of ganaxolone compared to placebo asadd-on therapy in adults with Drug-Resistant partial-onset seizures (POS).
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Drug-Resistant Epilepsy with Partial-Onset SeizuresMedDRA version: 18.0Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852
- Registration Number
- EUCTR2014-004363-21-BG
- Lead Sponsor
- Marinus Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 342
Male and female subjects 18 years of age and older able to provide written informed consent with a confident diagnosis of epilepsy with POS with or without secondary generalization with a POS frequency rate of =3 POS per 28-day who are currently treated on a stable regimen of AEDs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
Subjects must not have previous exposure to ganaxolone, generalized epilepsy, have less than 3 POS seizures per 28-day period or =21 seizure-free days. Subject should not have innumerable seizures, more than 100 POS total per each 4-week baseline period. No subjects will be admitted who have an active central nervous system (CNS) infection, demyelinating disease, degenerative neurological disease, CNS disease deemed progressive, clinically unstable psychiatric disorder, suicide attempt within the last 5 years, or current significant suicidal ideation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate efficacy of ganaxolone compared to placebo as<br>adjunctive therapy in adults with partial-onset seizures (POS), with or without secondary generalizations.;Secondary Objective: • To evaluate the safety and tolerability of ganaxolone compared to placebo as adjunctive therapy in adults with POS.<br>• To evaluate serum levels of ganaxolone at 1200 mg/d and 1800 mg/d after chronic dosing<br>• To evaluate the safety and tolerability of ganaxolone when administered as adjunctive therapy in adults with POS over a 12-month period.;Primary end point(s): Significant reduced in frequency of partial onset<br>seizures, with or without secondary generalizations, in patients treated with Ganaxolone compared to placebo;Timepoint(s) of evaluation of this end point: At end of 14 weeks of double blind treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • To evaluate the safety and tolerability of ganaxolone compared to placebo as adjunctive therapy in adults with POS.<br>• To evaluate serum levels of ganaxolone at 1200 mg/d and 1800 mg/d after chronic dosing<br>• To evaluate the safety and tolerability of ganaxolone when administered as adjunctive therapy in adults with POS over a 12-month period.;Timepoint(s) of evaluation of this end point: At every patient visit and at end of 68 weeks of open label treatment