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 - ND

• Conditions: Dravet Syndrome; Level: PTClassification code 10054859

• Registration Number: EUCTR2007-003702-95-IT
• Lead Sponsor: ISTITUTO C. MONDINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-07
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

-Aged between 6 months and 15 years,

-A signed Consent Form collection from parents or legal guardian

-Proven diagnosis of Dravet's syndrome *.

-Treated with VPA and CLB at usual dosages (at the appreciation of the investigator).

-Clonic or tonic-clonic seizures not adequately controlled with VPA and CLB at usual dosages (at the appreciation of the investigator).

-At least 2 clonic or tonic-clonic seizures and/or status epilepticus during the baseline period (a status epilepticus is defined as a clonic or tonic-clonic seizure lasting more than 15 minutes)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients currently treated or treated in the past with STP or TPM.

-Patients treated with any other AED that VPA and CLB in the months preceding the inclusion visit, with the exception of diazepam (VALIUM) and clonazepam (RIVOTRIL) if used only occasionally as emergency treatment for epileptic seizures.

-Patients treated with medications known as inhibitors of the CYP3A4 (macrolides, azol antifungal agents, theophylline) or with oral anti-coagulants.

-Parents or legal guardian unable to complete crisis diary.

-Ongoing pregnancy in a female patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified