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Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 and week 12

Summary

This trial is testing a medication called NBI-827104 to see if it can help children with a severe type of epilepsy that affects their brain activity during sleep by reducing abnormal brain signals.

Eligible Conditions
  • Epileptic Encephalopathy
  • Epileptic Spasms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6 and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Caregiver Global Impression of Change (GI-C) and Clinical Global Impression of Change (CGI-C) scores.
Clinical Global Impression of Severity (CGI-S) scores.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NBI-827104Experimental Treatment1 Intervention
NBI-827104 administered orally for 13 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered orally for 13 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NBI-827104
2021
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,305 Total Patients Enrolled
1 Trials studying Epileptic Encephalopathy
24 Patients Enrolled for Epileptic Encephalopathy
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,158 Total Patients Enrolled
1 Trials studying Epileptic Encephalopathy
24 Patients Enrolled for Epileptic Encephalopathy
~5 spots leftby Dec 2025
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