Primary Generalized Tonic-Clonic Seizures
Conditions
Brief summary
Proportion of subjects experiencing ≥50% reduction in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo
Detailed description
MPC in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo, Proportion of subjects experiencing PGTCS freedom from baseline through the DBP for XEN1101 versus placebo., Proportion of subjects experiencing “At least much improved” (including “Much” and “Very much improved”) in PGI-C at Week 12.
Interventions
DRUGXPF-010
DRUGXEN1101 placebo drug product consists of a size 3 white opaque HPMC capsule (Capsugel VCaps® Plus White OP)
containing 10mg of Avicel® PH102 (microscrystaline cellulose)
Sponsors
Xenon Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects experiencing ≥50% reduction in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| MPC in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo, Proportion of subjects experiencing PGTCS freedom from baseline through the DBP for XEN1101 versus placebo., Proportion of subjects experiencing “At least much improved” (including “Much” and “Very much improved”) in PGI-C at Week 12. | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, France, Germany, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed