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NBI-921352 for Developmental and Epileptic Encephalopathy Syndrome

Phase 2

Waitlist Available

Research Sponsored by Neurocrine Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have failed to achieve seizure freedom with at least 2 ASMs.

Be a male or female 2 to 21 years of age, inclusive.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up (end of) weeks 30, 54, 78, and 104

Awards & highlights

Study Summary

This trial will test how well and how safe the drug NBI-921352 works in children with SCN8A-DEE syndrome.

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions to NBI-921352 when taken alongside their current antiseizure medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 2 and 21 years old.

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My weight is at least 10 kilograms.

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I have SCN8A developmental and epileptic encephalopathy confirmed by tests.

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I am currently taking between 1 and 4 medications for seizures.

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I experience at least one motor seizure per week and haven't been seizure-free for over 20 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ (end of) weeks 30, 54, 78, and 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~(end of) weeks 30, 54, 78, and 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and (end of) weeks 30, 54, 78, and 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The participant incidence of serious treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation of study treatment, and fatal TEAEs.

Secondary outcome measures

Percentage change from baseline in 28-day seizure frequency for countable motor seizures during the Treatment Period of the study at (End of) Weeks 30, 54, 78, and 104.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NBI-921352Experimental Treatment1 Intervention

106 week treatment Period

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NBI-921352

2021

Completed Phase 2

~110

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor

75 Previous Clinical Trials

6,699 Total Patients Enrolled

Clinical Development LeadStudy DirectorNeurocrine Biosciences

24 Previous Clinical Trials

2,525 Total Patients Enrolled

Media Library

NBI-921352 Clinical Trial Eligibility Overview. Trial Name: NCT05226780 — Phase 2

Developmental and Epileptic Encephalopathy Syndrome Research Study Groups: NBI-921352

Developmental and Epileptic Encephalopathy Syndrome Clinical Trial 2023: NBI-921352 Highlights & Side Effects. Trial Name: NCT05226780 — Phase 2

NBI-921352 2023 Treatment Timeline for Medical Study. Trial Name: NCT05226780 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for individuals to join this clinical exploration?

"Per clinicaltrials.gov, this medical study is not currently enrolling patients. Although the trial was initially published on July 12th 2022 and modified for the last time on July 21st 2022, there are 1726 other trials that have open recruitment at this moment in time."

Answered by AI

What regulatory greenlight has NBI-921352 received from the FDA?

"Taking into account the Phase 2 status of NBI-921352, our team has assigned a safety ranking of 2. This is due to the lack of efficacy data but some preliminary evidence suggesting it's security profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEE

2022. "Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05226780.