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NBI-921352 for SCN8A Developmental and Epileptic Encephalopathy Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
SCN8A Developmental and Epileptic Encephalopathy SyndromeNBI-921352 - Drug
Eligibility
2 - 21
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • SCN8A Developmental and Epileptic Encephalopathy Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline, Maintenance Period: Week 6 to Week 16

Week 16
Convulsive Seizures
Percentage of Participants with a ≥ 25%, ≥ 50%, ≥ 75%, or 100% Treatment Response During the Maintenance Period
Week 16
Percentage Change from Baseline in 28-day Seizure Frequency for Countable Motor Seizures During the Treatment Period
Percentage of Participants with a ≥ 25%, ≥ 75%, or 100% Treatment Response During the Treatment Period
Percentage of Participants with a ≥ 50% Treatment Response for Countable Motor Seizures During the Treatment Period
Week 16
Change from Baseline in Clinical Global Impression of Severity (CGIS)
Change from Baseline in Parent/Caregiver Global Impression of Severity (GIS)
Week 16
Clinical Global Impression of Change (CGIC)
Parent/Caregiver Global Impression of Change (GIC)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
LP352
2
NBI-1065846
1
LP352

Trial Design

2 Treatment Groups

NBI-921352
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

52 Total Participants · 2 Treatment Groups

Primary Treatment: NBI-921352 · Has Placebo Group · Phase 2

NBI-921352
Drug
Experimental Group · 1 Intervention: NBI-921352 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, maintenance period: week 6 to week 16

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
70 Previous Clinical Trials
6,806 Total Patients Enrolled
1 Trials studying SCN8A Developmental and Epileptic Encephalopathy Syndrome
52 Patients Enrolled for SCN8A Developmental and Epileptic Encephalopathy Syndrome
Clinical Development LeadStudy DirectorNeurocrine Biosciences
21 Previous Clinical Trials
2,640 Total Patients Enrolled
1 Trials studying SCN8A Developmental and Epileptic Encephalopathy Syndrome
52 Patients Enrolled for SCN8A Developmental and Epileptic Encephalopathy Syndrome
Neurocrine ClinicalStudy DirectorNeurocrine Biosciences

Eligibility Criteria

Age 2 - 21 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of SCN8A-DEE supported by both clinical and genetic findings.
You are 2 to 21 years of age, inclusive.\n
You must have an adequate rescue medication regimen per the investigator's judgment in place at the time of screening and for the duration of the study.
You are treated with at least 1 other antiseizure medication (ASM), but no more than 4 ASMs.
You have a body weight of at least 10 kg.
The subject's parent/caregiver is able to accurately identify seizure types, especially countable motor seizures (defined as GTCS, tonic, atonic or FOS with noticeable motor component) and is able to complete seizure diary.
References

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