Trial Outcomes & Findings for A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine (NCT NCT06422377)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

Baseline to Week 12 of Maintenance Period

Results posted on

2025-07-29

Participant Flow

The study was terminated by the Sponsor due to a business decision (no safety concerns) as sufficient results were obtained from the previous studies and supplementary data from this study was not required. As there was only 1 participant in this study, no data is reported in order to protect and maintain participant privacy/confidentiality.

Participant milestones

Participant milestones
Measure	Soticlestat Participant received soticlestat at a starting dose of 100 milligrams (mg) to 200 mg in the 4-week titration. As a part of maintenance (initially planned for 48 weeks per protocol), participant remained on the 200 mg twice daily (BID) dose for 9 days followed by a 1-week taper to receive soticlestat 100 mg BID.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Soticlestat Participant received soticlestat at a starting dose of 100 milligrams (mg) to 200 mg in the 4-week titration. As a part of maintenance (initially planned for 48 weeks per protocol), participant remained on the 200 mg twice daily (BID) dose for 9 days followed by a 1-week taper to receive soticlestat 100 mg BID.
Overall Study Study Terminated by Sponsor	1

Baseline Characteristics

A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Baseline to Week 12 of Maintenance Period

Population: The study was terminated by the Sponsor due to a business decision (no safety concerns) as sufficient results were obtained from the previous studies and supplementary data from this study was not required. As there was only 1 participant in this study, no data is reported in order to protect and maintain participant privacy/confidentiality.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to Week 12 of Maintenance Period

Population: The study was terminated by the Sponsor due to a business decision (no safety concerns) as sufficient results were obtained from the previous studies and supplementary data from this study was not required. As there was only 1 participant in this study, no data is reported in order to protect and maintain participant privacy/confidentiality.

Outcome measures

Outcome data not reported

Adverse Events

Soticlestat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place