Medical Affairs

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Clinical Trials

Please click on the identifier number below to view a summary of current and past studies as posted on ClinicalTrials.gov.

Azetukalner (XEN1101) – Epilepsy

ClinicalTrials.gov Identifier NCT05614063: A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE2)

ClinicalTrials.gov Identifier NCT05716100: A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

ClinicalTrials.gov Identifier NCT05667142: A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures (X-ACKT)

ClinicalTrials.gov Identifier NCT05718817: An Open-label Study of XEN1101 in Epilepsy (OLE: Open-label extension of X-TOLE2, X-TOLE3, and X-ACKT studies)

Please note: For those living with either focal-onset seizures or primary generalized tonic-clonic seizures, you may be eligible for one of the ongoing clinical trials listed above. Learn more here.

Previous Studies:

ClinicalTrials.gov Identifier NCT03796962: Phase 2b Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

ClinicalTrials.gov Identifier NCT03468725: Phase 1b Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101

ClinicalTrials.gov Identifier NCT03340220: Phase 1a Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN1101

Azetukalner (XEN1101) – Major Depressive Disorder

ClinicalTrials.gov Identifier NCT06775379: A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA2)

Previous Studies:

ClinicalTrials.gov Identifier NCT05376150: A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder (X-NOVA)

ClinicalTrials.gov Identifier NCT04827901: Investigator-Led Study to Evaluate XEN1101 for Major Depressive Disorder (Icahn School of Medicine at Mount Sinai)

NBI-921352: Partnered Program with Neurocrine Biosciences (previously XEN901) 

ClinicalTrials.gov Identifier NCT04873869: Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

Previous Studies:

ClinicalTrials.gov Identifier NCT05159908: A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

ClinicalTrials.gov Identifier NCT03467100: Phase 1 Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901