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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, maintenance period: week 6 to week 16
Awards & highlights

Study 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.Check my eligibility
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).See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, maintenance period: week 6 to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, maintenance period: week 6 to week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage Change from Baseline in 28-day Seizure Frequency for Countable Motor Seizures During the Treatment Period
Secondary outcome measures
Change from Baseline in Clinical Global Impression of Severity (CGIS)
Change from Baseline in Parent/Caregiver Global Impression of Severity (GIS)
Clinical Global Impression of Change (CGIC)
+5 more

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

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,717 Total Patients Enrolled
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,543 Total Patients Enrolled
Neurocrine ClinicalStudy DirectorNeurocrine Biosciences

Media Library

NBI-921352 Clinical Trial Eligibility Overview. Trial Name: NCT04873869 — Phase 2
Developmental and Epileptic Encephalopathy Syndrome Research Study Groups: Placebo, NBI-921352
Developmental and Epileptic Encephalopathy Syndrome Clinical Trial 2023: NBI-921352 Highlights & Side Effects. Trial Name: NCT04873869 — Phase 2
NBI-921352 2023 Treatment Timeline for Medical Study. Trial Name: NCT04873869 — Phase 2

Frequently Asked Questions

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

How many people are allowed to sign up for this experiment?

"That is correct. The information available on clinicaltrials.gov states that this trial began recruitment on 1/31/2022 and is still looking for patients as of 6/27/2022. So far, 52 people have been admitted at 11 different locations."

Answered by AI

Are people of all ages welcome to participate in this research?

"Children aged 2 to 21 qualify for this particular trial. Out of the 532 clinical trials that exist for people under 18, this is one. 1258 trials target patients over 65 years old."

Answered by AI

What is the regulatory status of NBI-921352?

"NBI-921352 is currently in Phase 2 of clinical trials, meaning that there is some evidence supporting its safety but none yet for efficacy. Our team at Power has given it a score of 2 out of 3."

Answered by AI

Are there any patients needed for this research project?

"Currently, this clinical trial is recruiting patients that fit the specified criteria. The listing was first posted on January 31st, 2022 and has been updated as recently as June 27th, 2022."

Answered by AI

Which patients fit the bill for this clinical trial?

"In order to qualify for this experiment, volunteers must experience aura and be between 2-21 years old. Up to 52 individuals will be accepted."

Answered by AI
~23 spots leftby Dec 2025