At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
NBI-827104 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
In Brief
A Phase 2 clinical trial evaluating NBI-827104 and Placebo for Epileptic Encephalopathy and Continuous Spike and Wave During Sleep. Completed, enrolled 24 participants across 15 sites in 6 countries.
Detailed Summary
This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Denmark, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartApr 2021
Primary CompletionAug 2022
Study CompletionOct 2022
TodayJul 2026
First PostedNov 12, 2020
Enrollment StartApr 26, 2021
Primary CompletionAug 8, 2022
Study CompletionOct 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.6 years ago
Interventions
NBI-827104drug
Triple T-type calcium channel blocker.
Placebodrug
Non-active dosage form.