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Clinical trial of Soticlestat as adjuvant treatment in patients with Dravet syndrome or Lennox-Gastaut syndrome.

THIS STUDY WILL EVALUATE THE SAFETY AND TOLERABILITY OF SOTICLESTAT WHEN ADMINISTERED WITH OTHER ANTIEPILEPTIC TREATMENTS IN A PEDIATRIC (CHILDREN) AND YOUNG ADULT POPULATION WITH DRAVET SYNDROME (DS) OR LENNOX-GASTAUT SYNDROME (LGS). THE PURPOSE OF THIS STUDY IS TO DETERMINE THE FOLLOWING: -HOW SAFE SOTICLESTAT IS IN PEOPLE WITH DS OR LGS BY LONG-TERM MONITORING FOR POSSIBLE SIDE EFFECTS. -HOW WELL PEOPLE WITH DS OR SLG TOLERATE TREATMENT WITH SOTICLESTAT IN ADDITION TO OTHER ANTIEPILEPTIC TREATMENTS (USUAL TREATMENT). -EFFECTS OF SOTICLESTAT ON THE REDUCTION OF SEIZURE FREQUENCY IN THE DS GROUP (SEIZURES WITH RAPID AND SOMETIMES VIOLENT SHAKING MOVEMENTS) AND THE REDUCTION OF THE FREQUENCY OF MAJOR MOTOR DROP SEIZURES (CIM) IN THE SLG GROUP (SEIZURES WITH INCREASED OR DECREASED MUSCLE CONTRACTION) WHEN GIVEN WITH OTHER ANTIEPILEPTIC TREATMENT. -EFFECTS OF SOTICLESTAT ON SEIZURE INTENSITY AND DURATION BY MEANS OF A QUESTIONNAIRE TO BE FILLED IN BY PARENTS OR CAREGIVERS. -EFFECTS OF SOTICLESTAT ON THEIR QUALITY OF LIFE BY MEANS OF A QUESTIONNAIRE AND OTHER ASSESSMENTS TO BE COMPLETED BY THEIR PARENTS OR CAREGIVER. -EFFECTS OF TREATMENT WITH SOTICLESTAT ON YOUR PARENTS' OR CAREGIVER'S QUALITY OF LIFE BY MEANS OF A QUESTIONNAIRE TO BE COMPLETED BY YOUR PARENTS OR CAREGIVER.

Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Pamplona

Technical Summary

  • PROSPECTIVE, OPEN-LABEL, MULTICENTER, PHASE 3 EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF SOTICLESTAT AS ADJUVANT TREATMENT IN PATIENTS WITH DRAVET SYNDROME OR LENNOX-GASTAUT SYNDROME (ENDYMION 2)
  • Code EudraCT: 2021-002482-17
  • Protocol number: TAK 935-3003
  • Promoter: Takeda Pharmaceuticals International Co.
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

More information about this clinical trial

Information offered by the Spanish Registry of Clinical Studies

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