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

TerminatedPhase 3

Sponsor: Takeda

Conditions: Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)

Interventions: Soticlestat

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

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

Eligibility overview

Sex: ALL

Age: 2 Years to 56 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1\. Participant must have:

* Been previously enrolled in a phase 3 soticlestat clinical 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.
2. Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) \>450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF.
3. Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.

Locations (116)

Phoenix, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Iowa City, Iowa, United States
Bethesda, Maryland, United States
Saint Paul, Minnesota, United States
Livingston, New Jersey, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
York, Pennsylvania, United States
Charleston, South Carolina, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Randwick, New South Wales, Australia
Brisbane, Queensland, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
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