Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422377
Status:
TERMINATED
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
An Open-label Nonrandomized Phase 3 Study to Evaluate the Efficacy and Safety of Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision unrelated to patient safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to check how soticlestat impacts symptoms of Dravet syndrome DS and Lennox-Gastaut syndrome LGS in participants who have been exposed to fenfluramine
Detailed Description:
The drug being tested in this study is called soticlestat Soticlestat is being tested to treat people who have DS or LGS and have been exposed to fenfluramine This study will assess the efficacy and safety of soticlestat in addition to standard care in the treatment of DS or LGS
The study will enroll approximately 45 patients This study comprises a screening period of up to 6 weeks a 4-week titration period a 48-week maintenance period a taper period of up to 1 week and a follow-up safety visit Participants will be enrolled to receive soticlestat along with the standard of care
Soticlestat 100-300 mg
Participants will receive oral administration of soticlestat Dose 1 days 1 to 7 Dose 2 days 8 to 14 and Dose 3 Days 15 to 28 with a minimum dose of 100 mg to a maximum dose of 300 mg depending on participants body weight in the titration period followed by maintenance period up to end of treatment up to approximately 52 weeks Percent change from baseline in convulsive in participants with DS and major motor drop MMD in participants with LGS seizure frequency per 28 days during the initial 12 weeks of the maintenance period will be assessed
This multi-center trial will be conducted in the United Kingdom and Europe The overall time to participate in this study is approximately 60 weeks Participants will make multiple visits to the clinic and will be followed up for safety by visiting the clinic or by telephone approximately 2 weeks after the last dose of the study drug
The study will enroll approximately 45 patients This study comprises a screening period of up to 6 weeks a 4-week titration period a 48-week maintenance period a taper period of up to 1 week and a follow-up safety visit Participants will be enrolled to receive soticlestat along with the standard of care
Soticlestat 100-300 mg
Participants will receive oral administration of soticlestat Dose 1 days 1 to 7 Dose 2 days 8 to 14 and Dose 3 Days 15 to 28 with a minimum dose of 100 mg to a maximum dose of 300 mg depending on participants body weight in the titration period followed by maintenance period up to end of treatment up to approximately 52 weeks Percent change from baseline in convulsive in participants with DS and major motor drop MMD in participants with LGS seizure frequency per 28 days during the initial 12 weeks of the maintenance period will be assessed
This multi-center trial will be conducted in the United Kingdom and Europe The overall time to participate in this study is approximately 60 weeks Participants will make multiple visits to the clinic and will be followed up for safety by visiting the clinic or by telephone approximately 2 weeks after the last dose of the study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504104-29 | OTHER | EU CTIS | None |