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NBI-827104 for Epileptic Encephalopathy

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
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is effective, safe, and tolerated in children with a specific type of epilepsy.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ratio of spike-wave index (SWI) during first hour of nonrapid eye movement (NREM) sleep based on centralized video-EEG reading.
Secondary outcome measures
Caregiver Global Impression of Change (GI-C) and Clinical Global Impression of Change (CGI-C) scores.
Clinical Global Impression of Severity (CGI-S) scores.
Ratio of SWI during first hour of NREM sleep, based on centralized evaluation.

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
6,745 Total Patients Enrolled
1 Trials studying Epileptic Encephalopathy
24 Patients Enrolled for Epileptic Encephalopathy
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,571 Total Patients Enrolled
1 Trials studying Epileptic Encephalopathy
24 Patients Enrolled for Epileptic Encephalopathy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
2021. "Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04625101.
~6 spots leftby Apr 2025
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