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A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome
A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome

NCT04940624

CompletedPhase 3

Sponsor: Takeda

Conditions: Dravet Syndrome (DS)

Interventions: Soticlestat, Placebo

Countries: United States, Australia, Brazil, Canada, China, France, Germany, Greece

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS. Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it. Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.

Eligibility overview

Sex: ALL

Age: 2 Years to 21 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Has documented clinical diagnosis of DS.
2. Had ≥12 convulsive seizures over 12 weeks before screening based on the historical information and has had ≥4 convulsive seizures per 28 days during the 4- to 6-week prospective baseline period.
3. Weighs ≥10 kg at the screening visit (Visit 1).
4. Failure to control seizures despite appropriate trials of at least 1 ASM based on historical information and is currently on an antiseizure therapy or other treatment options considered as SOC.
5. Artisanal cannabidiols are allowed at a stable dose for at least 4 weeks before the screening visit (Visit 1); the dosing regimen and manufacturer should remain constant throughout the study (Artisanal cannabidiols will not be counted as ASMs.).
6. Currently taking 0 to 4 ASMs at stable doses for at least 4 weeks before the screening visit (Visit 1); benzodiazepines used chronically (daily) to treat seizures are considered ASMs. Fenfluramine and cannabidiol (Epidiolex) are allowed where available and should be counted as an ASM. ASM dosing regimen must remain constant throughout the study.

Exclusion Criteria:

1\. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.
Locations (66)
  • Phoenix, Arizona, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Atlanta, Georgia, United States
  • Iowa City, Iowa, United States
  • New York, New York, United States
  • Toledo, Ohio, United States
  • Charleston, South Carolina, United States
  • Seattle, Washington, United States
  • Tacoma, Washington, United States
  • South Brisbane, Queensland, Australia
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, Brazil
  • Calgary, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • Toronto, Ontario, Canada
  • Beijing, Beijing Municipality, China
  • Beijing, Beijing Municipality, China
  • Chongqing, Chongqing Municipality, China
  • Guangzhou, Guangdong, China
  • Shenzhen, Guangdong, China
  • Wuhan, Hubei, China
  • Changsha, Hunan, China
  • Changchun, Jilin, China
  • Shanghai, Shanghai Municipality, China
  • Shanghai, Shanghai Municipality, China
  • Marseille, France
  • Paris, France
  • Paris, France
  • + 36 more on CT.gov