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Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep (Steamboat 2)

Primary Purpose

Epileptic Encephalopathy, Continuous Spike and Wave During Sleep

Status
Enrolling by invitation
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NBI-827104
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epileptic Encephalopathy focused on measuring Epilepsy, Epileptic Encephalopathy, Neurocrine, NBI-827104, Steamboat 2

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  1. 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.
  2. Body weight <10 kg at randomization Day 1.
  3. Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.
  4. 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.

Sites / Locations

  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NBI-827104

Arm Description

NBI-827104 administered orally

Outcomes

Primary Outcome Measures

The Occurrence of Serious Treatment-emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Full Information

First Posted
March 21, 2022
Last Updated
August 17, 2023
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05301894
Brief Title
Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Acronym
Steamboat 2
Official Title
Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epileptic Encephalopathy, Continuous Spike and Wave During Sleep
Keywords
Epilepsy, Epileptic Encephalopathy, Neurocrine, NBI-827104, Steamboat 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NBI-827104
Arm Type
Experimental
Arm Description
NBI-827104 administered orally
Intervention Type
Drug
Intervention Name(s)
NBI-827104
Intervention Description
T-type calcium channel blocker.
Primary Outcome Measure Information:
Title
The Occurrence of Serious Treatment-emergent Adverse Events (TEAEs)
Time Frame
Day 1 up to 238 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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). Key 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Lead
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Neurocrine Clinical Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Neurocrine Clinical Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Neurocrine Clinical Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Neurocrine Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Neurocrine Clinical Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Neurocrine Clinical Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Neurocrine Clinical Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Neurocrine Clinical Site
City
Dianalund
ZIP/Postal Code
4293
Country
Denmark
Facility Name
Neurocrine Clinical Site
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Neurocrine Clinical Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Neurocrine Clinical Site
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
Neurocrine Clinical Site
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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