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NCT05493293
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
Phase 2 trial testing NBI-921352 in Focal Onset Seizure in 82 participants. Terminated before completion.
11 March 2024
Quick facts
| Lead sponsor | Neurocrine Biosciences |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 9 November 2022 |
| Primary completion | 11 March 2024 |
| Estimated completion | 11 March 2024 |
| Sites | 26 locations across France, Italy, Belgium, Hungary, Australia, Spain, Czechia |
Drugs / interventions tested
- NBI-921352 — full drug profile →
Conditions studied
- Focal Onset Seizure — all drugs for Focal Onset Seizure →
- Focal Onset Epilepsy — all drugs for Focal Onset Epilepsy →
Sponsor
Neurocrine Biosciences — full company profile →
Who can join
Adults 18 to 67, any sex, with Focal Onset Seizure or Focal Onset Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Tuning Sodium Channel Blockers to the Near-Atomic Level.
Eyal S. · · 2024 · cited 2× · PMID 39280048 · DOI 10.1177/15357597231225065
Verify or expand the search:
- PubMed search for NCT05493293
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NBI-921352
Trials testing the same drug.
- NCT04873869 — Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syn · Phase 2 · terminated
- NCT05159908 — A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications · Phase 2 · completed
Other recruiting trials for Focal Onset Seizure
Currently open trials in the same condition.
- NCT07219407 — A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures · Phase 2 · recruiting
- NCT06453213 — Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy · Phase 4 · active not recruiting
Other Neurocrine Biosciences trials
Trials by the same sponsor.
- NCT07187375 — Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Le · Phase 2 · recruiting
- NCT06267846 — A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder · Phase 2 · completed
- NCT05859698 — Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyski · Phase 4 · completed
- NCT05654870 — Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia · Phase 3 · terminated
- NCT05545111 — Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05493293 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Neurocrine Biosciences
- Last refreshed: 12 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05493293.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing