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Clinical trial of soticlestat as adjuvant treatment in pediatric and adult subjects with Lennox-Gastaut syndrome (LGS).

THE PURPOSE OF THIS STUDY IS TO DETERMINE THE FOLLOWING: ¿ EFFECTS OF SOTICLESTAT IN REDUCING THE FREQUENCY OF MAJOR MOTOR DROP SEIZURES (CMI; SEIZURES DUE TO INCREASED OR DECREASED MUSCLE CONTRACTION) WHEN GIVEN WITH OTHER ANTIEPILEPTIC TREATMENTS. ¿ SAFETY OF SOTICLESTAT IN PEOPLE WITH SLG BY MONITORING FOR SIDE EFFECTS. ¿ VARIATIONS IN TOTAL SEIZURE FREQUENCY OF ALL TYPES AFTER RECEIVING SOTICLESTAT. ¿ BLOOD CONCENTRATION OF SOTICLESTAT OVER TIME. ¿ EFFECTS OF SOTICLESTAT ON YOUR QUALITY OF LIFE THROUGH A QUESTIONNAIRE AND OTHER ASSESSMENTS TO BE COMPLETED BY YOUR PARENT OR CAREGIVER. ¿ EFFECTS OF SOTICLESTAT TREATMENT ON YOUR PARENT'S OR CAREGIVER'S QUALITY OF LIFE THROUGH A QUESTIONNAIRE TO BE COMPLETED BY YOUR PARENT OR CAREGIVER.

Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Pamplona

Technical Summary

  • MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SOTICLESTAT AS ADJUVANT TREATMENT IN PEDIATRIC AND ADULT SUBJECTS WITH LENNOX-GASTAUT SYNDROME (LGS).
  • Code EudraCT: -
  • Protocol number: TAK-935-3002
  • Promoter: Takeda Development Center Americas, Inc.
  • 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.

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