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

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2010-023505-36-IT
• Date of registration: 05/01/2012
• Prospective Registration: No
• Primary sponsor: EISAI LTD UK
• Public 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
• 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 - E2080-G000-303
• Date of first enrolment: 29/09/2011
• Target sample size: 75
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023505-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: Investigators Choice of Approved AED Number of treatment arms in the trial: 2

Countries of recruitment

Greece, Italy

Contacts

• Name: Medical Information
• Affiliation: Eisai Ltd

• Name: Medical Information
• Affiliation: Eisai Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Age = 1 and < 4 years Clinical diagnosis of LGS at screening, which might include the presence of a slow background 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, subjects with a diagnosis of atypical benign partial epilepsy (pseudo-Lennox syndrome), or continuous spike-waves of slow sleep (CSWS) On a fixed dose of one to three concomitant regionally approved antiepileptic drugs (AEDs) for a minimum of 8 weeks prior to randomization with an inadequate response to treatment Consistent seizure documentation (i.e., no uncertainty of the presence of seizures) and AED treatment documentation during the 8 week prerandomization period Written informed consent provided by parent(s)/legal representative(s) Are able to comply with all aspects of the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
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:
- Familial short QT syndrome - Prior treatment with rufinamide


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Lennox Gastaut Syndrome
MedDRA version: 14.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Inovelon
Pharmaceutical Form: Oral suspension
CAS Number: 106308-44-5
Current Sponsor code: Rufinamide
Other descriptive name: Rufinamide oral suspension
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Pharmaceutical Form:
INN or Proposed INN: lamotrigine
CAS Number: 84057-84-81
Other descriptive name: Lamictal
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 400-

Pharmaceutical Form:
INN or Proposed INN: sodio valproato
CAS Number: 99-66-1
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 25-30

Pharmaceutical Form:
INN or Proposed INN: topimarato
CAS Number: 97240-79-4
Other descriptive name: topimarate
Concentration unit: mg/g milligram(s)/gram
Concentration type: range
Concentration number: 25-400

Primary Outcome(s)

Main Objective: To compare the effect of 2 drug regimens consisting of either rufinamide or any other approved AED of the investigator's choice as an add-on to the subject's existing regimen of 1-3 AEDs on the overall safety and tolerability of rufinamide in subjects aged 1 to less than 4 years of age with inadequately controlled LGS To characterize the age group specific pharmacokinetics of rufinamide in a pediatric population, 1 to less than 4 years of age, with inadequately controlled LGS, using the population approach To evaluate the effect of rufinamide as adjunctive treatment on the cognitive development and behavioral effects in a pediatric population, 1 to less than 4 years of age, with inadequately controlled LGS.

Primary end point(s): Primary efficacy variable: Change from baseline in CBCL Total Problems Score to the end of the 2- year (106 weeks) treatment period

Timepoint(s) of evaluation of this end point: Baseline to end of 2 year treatment period. Physical and neurological examinations will be performed at screening, baseline, Visits 3, 4, 5, 7, 10, 12, 13, 14, and follow up/final visit.

Secondary Objective:

Secondary ID(s)

E2080-G000-303

Source(s) of Monetary Support

Eisai Ltd