Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2025-01-27

Brief Summary

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The primary objective for this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS).

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Detailed Description

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This study will enroll participants who completed treatment in the Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group Study NBI-827104-CSWS2010 (NCT04625101). Participants who did not participate in Study NBI-827104-CSWS2010 may also be eligible for enrollment.

Conditions

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Epileptic Encephalopathy Continuous Spike and Wave During Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NBI-827104

NBI-827104 administered orally

Group Type EXPERIMENTAL

NBI-827104

Intervention Type DRUG

T-type calcium channel blocker.

Interventions

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NBI-827104

T-type calcium channel blocker.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:

* Completed 12 weeks of treatment in Study NBI-827104-CSWS2010.

For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:

* Have diagnosis of EECSWS confirmed by the Diagnosis Confirmation Panel (DCP).

Exclusion Criteria

For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:

* Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.

For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:

* Body weight \<15 kg at Day 1.
* Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.
* Presence of relevant neurological disorders other than EECSWS and its underlying conditions as judged by the investigator. Symptomatic conditions underlying EECSWS (for example, neonatal strokes) have to be stable for at least 1 year prior to screening.
* Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit.
* Used any active investigational drug other than NBI-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before screening or plans to use such an investigational drug (other than NBI-827104) during the study.
* Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No