NBI-921352 for Developmental and Epileptic Encephalopathy Syndrome

Recruiting at 3 trial locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Neurocrine Biosciences

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Extension study to evaluate how safe and tolerable the drug NBI-921352 is when used as adjunctive therapy in participants with SCN8A developmental and epileptic encephalopathy syndrome (SCN8A-DEE).

Research Team

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Eligibility Criteria

This trial is for individuals with SCN8A-DEE, a severe form of epilepsy. Participants can be those who completed the prior NBI-921352 study or new patients aged 2 to 21, averaging at least one seizure per week and not seizure-free for over 20 days. They must be on 1-4 other antiseizure meds and have failed two others.

Inclusion Criteria

I, or my guardian, have given consent for me to participate.

I, or my guardian, have given consent for me to participate.

I still have seizures despite trying at least 2 seizure medications.

Exclusion Criteria

My epilepsy symptoms don't match those of Dravet syndrome.

I am using medical marijuana or cannabinoids, not including Epidiolex/Epidyolex, with sponsor approval.

Have a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are, in the investigator's opinion, likely to affect nervous system functioning.

Treatment Details

Interventions

• NBI-921352 (Unknown)

Trial Overview The safety and tolerability of NBI-921352 as an additional treatment are being tested in this extension study for people with SCN8A developmental and epileptic encephalopathy syndrome (SCN8A-DEE).

Participant Groups

Group I: NBI-921352 Experimental Treatment 1 Intervention

NBI-921352 administered for up to 164 weeks.

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials

78

Recruited

6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD