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NCT04625101 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Neurocrine Biosciences.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target

NCT04625101 is a Phase 2 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 24 participants.

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The verdict

NCT04625101, a Phase 2 study, has completed, sponsored by Neurocrine Biosciences.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study Summary

This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS).

Interventions

  • DRUG Placebo
  • DRUG NBI-827104

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2021-04-26
Est. Completion 2022-10-11
Phase Phase 2

Sponsor

Neurocrine Biosciences

65 total trials

What the Registry Record Tells You About NCT04625101

The ClinicalTrials.gov registry entry for NCT04625101 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04625101 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04625101 about?

NCT04625101 is a clinical study titled "Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep". This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS).

What is the current status of trial NCT04625101?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2021-04-26. Estimated completion is 2022-10-11.

What interventions are being tested in trial NCT04625101?

The interventions under investigation include: Placebo (DRUG), NBI-827104 (DRUG).

Who is sponsoring clinical trial NCT04625101?

This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.