Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01405053
• Date of registration: 27/07/2011
• Prospective Registration: No
• Primary sponsor: Eisai Inc.
• Public title: Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs
• Scientific title: A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome
• Date of first enrolment: June 16, 2011
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01405053
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, France, Greece, India, Italy, Poland, South Africa, United States

Contacts

• Name: Alexis Arzimanoglou Arzimanoglou
• Affiliation: Hopital Femme-Mere-Enfant Service D'Epilepsie -5eme etage 59 Boulevard Pinel Bron, France

Key inclusion & exclusion criteria

Key Inclusion:

1. Clinical diagnosis of LGS, which might include the presence of a slow background
electroencephalogram (EEG) rhythm, slow spikes-waves pattern (less than 3 Hz), the
presence of polyspikes; care should be taken not to include benign myoclonic epilepsy
of infancy, atypical benign partial epilepsy (pseudo-Lennox syndrome), or continuous
spike-waves of slow sleep (CSWS).

2. On a fixed and documented dose of one to three concomitant regionally approved
antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to randomization with an
inadequate response to treatment.

3. Consistent seizure documentation (i.e., no uncertainty of the presence of seizures)
during the pre-randomization phase.

Key Exclusion:

1. Familial short QT syndrome

2. Prior treatment with rufinamide within 30 days of baseline visit or discontinuation of
rufinamide treatment due to safety issues related to rufinamide



Age minimum: 1 Year
Age maximum: 3 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lennox-Gastaut Syndrome

Intervention(s)

Drug: Any other approved Antiepileptic Drug

Drug: Rufinamide

Primary Outcome(s)

Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period [Time Frame: End of Treatment Period (up to approximately Week 106)]

Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period [Time Frame: Baseline and End of Treatment Period (up to approximately Week 106)]

Secondary ID(s)

E2080-G000-303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01405053