Phase 3
N=62
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01999777 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants That Were Seizure-free — 17; 12 Participants — p=0.1972
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- USL261 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma S.P.R.L.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Were Seizure-free |
17; 12 | 0.1972 |
| SECONDARY Time to First Seizure Following Treatment (TFSFT) |
NA; 3.9 | 0.1388 |
Summary
This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.
Eligibility Criteria
Inclusion Criteria
- Subject has been admitted to the institution's EMU for seizure characterization or pre-surgical evaluation, or such admission is planned within 28 days
- Subject body weight is ≥ 40 kg to ≤ 125 kg (inclusive)
- Subject has an established diagnosis of partial or generalized epilepsy
Exclusion Criteria
- Subject has history of status epilepticus in the 6 months prior to Screening
- Subject has a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 12 months
- Subject has respiratory failure (or is at risk for respiratory failure) or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
- Subject has acute narrow-angle glaucoma
- Subject is receiving chronic benzodiazepine treatment (defined as an average of ≥ 4 administrations per week) and cannot safely withdraw from such treatment within the washout period prior to treatment
Data sourced from ClinicalTrials.gov (NCT01999777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.