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NBI-921352 for Epilepsy

Phase 2

Recruiting

Research Sponsored by Neurocrine Biosciences

Eligibility Criteria Checklist

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

Must have

Being treated with at least 1 but no more than 4 antiseizure medications (ASMs)

On average at least 1 countable motor seizure per week and not seizure-free for more than 20 consecutive days

Must not have

Symptoms consistent with another epilepsy disorder such as Dravet syndrome

History of moderate or severe head trauma or other neurological disorders or systemic medical diseases likely to affect nervous system functioning

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new drug to see if it is effective and safe in treating seizures in people with a certain type of epilepsy.

Who is the study for?

This trial is for children and young adults aged 2 to 21 with SCN8A Developmental and Epileptic Encephalopathy Syndrome. Participants must weigh at least 10 kg, have frequent seizures despite taking up to four antiseizure medications, and not be seizure-free for over 20 days.

What is being tested?

The study tests NBI-921352 as an additional treatment alongside existing antiseizure medications in patients with SCN8A-DEE. It aims to evaluate the drug's effectiveness in reducing seizures compared to a placebo (a substance with no therapeutic effect).

What are the potential side effects?

While specific side effects of NBI-921352 are not listed here, common side effects from epilepsy drugs can include dizziness, fatigue, gastrointestinal issues like nausea or vomiting, mood changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am currently taking 1 to 4 medications for seizures.

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I have at least one noticeable seizure every week and haven't been seizure-free for more than 20 days in a row.

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I am between 2 and 21 years old.

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My caregiver can identify and record different types of my seizures.

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I weigh at least 10 kg.

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I have been diagnosed with SCN8A-DEE based on symptoms and genetic tests.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms similar to Dravet syndrome.

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I have had a serious head injury or disease affecting my brain.

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I am using medical marijuana or cannabinoids, not including Epidiolex/Epidyolex, unless approved.

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I am currently on steroids, not including asthma or allergy treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NBI-921352Experimental Treatment1 Intervention

In the first 6 weeks participants will receive increasing doses of NBI-921352 (Titration Period) based on weight, followed by 10 weeks of treatment at their final tolerated dose (Maintenance Period) and 2 weeks of treatment with decreasing doses (Taper Period).

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive matching placebo for up to 18 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NBI-921352

2021

Completed Phase 2

~110

0 / 11Eligibility criteria met