Your session is about to expire
← Back to Search
Unknown
NBI-827104 for Epilepsy (Steamboat 2 Trial)
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 day 1 up to 238 weeks
Awards & highlights
Steamboat 2 Trial Summary
This trial is testing a new drug for safety, tolerability, and effectiveness in children with a rare genetic disorder called EECSWS. The trial will enroll children who have completed a previous study testing the same drug.
Who is the study for?
This trial is for children with a specific brain condition called EECSWS. Those who completed a prior study (NBI-827104-CSWS2010) can join, as well as new participants with confirmed EECSWS diagnosis. Kids under 15kg, those with certain heart or lab issues, other neurological disorders not stable for at least a year, planned brain surgery within six weeks of the trial start, or recent use of investigational drugs cannot participate.Check my eligibility
What is being tested?
The study tests the long-term safety and effects of NBI-827104 in kids with EECSWS. It's an extension study meaning it continues from previous research to gather more data on how safe and tolerable this medication is over time for these pediatric patients.See study design
What are the potential side effects?
While specific side effects are not listed here, the trial aims to monitor how well children tolerate NBI-827104 over an extended period and any adverse reactions they might have due to its continued use.
Steamboat 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 up to 238 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to 238 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Occurrence of Serious Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Caregiver Global Impression of Change score
Change from baseline in Clinical Global Impression of Severity score
Clinical Global Impression of Change score
+1 moreSteamboat 2 Trial Design
1Treatment groups
Experimental Treatment
Group I: NBI-827104Experimental Treatment1 Intervention
NBI-827104 administered orally
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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for brain surgery due to structural abnormalities.Your doctor found important heart or lab test results during your screening.My EECSWS diagnosis has been confirmed by a specialized panel.I weigh less than 15 kg and did not come from study NBI-827104-CSWS2010.If you were in another study before this one, you must have finished the treatment for at least 12 weeks.You have other neurological disorders besides EECSWS or its underlying conditions, as determined by the doctor. Any symptomatic conditions related to EECSWS (like neonatal strokes) must have been stable for at least 1 year before screening.
Research Study Groups:
This trial has the following groups:- Group 1: NBI-827104
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots in this experiment for volunteers?
"According to the clinicaltrials.gov listings, this experiment is not presently accepting new patients. Initially posted on June 7th 2022, and last amended August 30th 2022, there are currently 364 other medical trials seeking participants."
Answered by AI
What potential risks have been associated with NBI-827104?
"The safety of the NBI-827104 drug was rated a 2 as it is currently undergoing phase two trials, in which data on its efficacy has yet to be collected."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger