A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY

Registry ID

EUCTR2007-003702-95

Source registry

EUCTR

Status

Ongoing

Phase

PHASE3

Sponsor

ISTITUTO C. MONDINO

Start date

2007-07-03

Last update

2026-08-16

Conditions

• Dravet Syndrome

Summary

evaluate the efficacy of STP and TPM, used as an add-on therapy in addition to VPA and CLB used at usual dosages, on the clonic or tonic-clonic seizures in paediatric patients with Dravet’s syndrome not adequately controlled with clobazam and valproate, compared to CLB used at the maximal tolerated dosage

Locations

• , , Italy

Related clinical trials

• A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
• A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
• A Double-blind Study Evaluating the Efficacy, Safety, and Tolerability of Zorevunersen in Patients With Dravet Syndrome
• ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome
• A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
• The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project

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