Trials / Completed
CompletedNCT04625101
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 4 Years – 12 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NBI-827104 | Triple T-type calcium channel blocker. |
| DRUG | Placebo | Non-active dosage form. |
Timeline
- Start date
- 2021-04-26
- Primary completion
- 2022-08-08
- Completion
- 2022-10-11
- First posted
- 2020-11-12
- Last updated
- 2025-09-05
- Results posted
- 2025-09-05
Locations
15 sites across 6 countries: United States, Canada, Denmark, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04625101. Inclusion in this directory is not an endorsement.