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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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11 April 2016 |
Main ID: |
EUCTR2010-023505-36-GR |
Date of registration:
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08/08/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome.
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Scientific title:
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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:
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08/08/2012 |
Target sample size:
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75 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023505-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Greece
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Italy
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South Africa
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United States
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Contacts
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Name:
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Medical Information
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Address:
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Mosquito Way
AL10 9SN
Hatfield
United Kingdom |
Telephone:
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+4408456761400 |
Email:
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EUMedInfo@eisai.net |
Affiliation:
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Eisai Ltd |
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Name:
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Medical Information
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Address:
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Mosquito Way
AL10 9SN
Hatfield
United Kingdom |
Telephone:
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+4408456761400 |
Email:
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EUMedInfo@eisai.net |
Affiliation:
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Eisai Ltd |
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Key inclusion & exclusion criteria
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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 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria: Familial short QT syndrome
Prior treatment with rufinamide within 30 days of Baseline Visit or discontinuation of rufinamide treatment due to safety issues related to rufinamide (revised per Amendment 01)
Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal,
renal disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct
Subject with hypersensivity to rufinamide and /or triazole or any of the excipients
Any history of or concomitant medical condition that, in the opinion of the
Investigator, would compromise the subject’s ability to safely complete the study
Scheduled for surgery during the projected course of the study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Lennox Gastaut Syndrome MedDRA version: 14.1
Level: PT
Classification code 10048816
Term: Lennox-Gastaut syndrome
System Organ Class: 10029205 - Nervous system disorders
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Product Name: rufinamide oral suspension Product Code: rufinamide oral suspension Pharmaceutical Form: Oral suspension INN or Proposed INN: RUFINAMIDE CAS Number: 106308-44-5 Current Sponsor code: E2080 Other descriptive name: Rufinamide oral suspension Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40-
Trade Name: Investigators choice of approved AEDs Pharmaceutical Form: INN or Proposed INN: Investigators Choice of Approved AED CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A
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Primary Outcome(s)
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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.
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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
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Secondary Objective: N/A
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Timepoint(s) of evaluation of this end point: Baseline to end of 2 year treatment period. Physical and neurological examinations (the latter only if possible) will be performed at screening, baseline, Visits 3, 4, 5, 7, 8, 10, 12, 13, and follow up/final visit.
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Secondary Outcome(s)
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Secondary end point(s): N/A
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Timepoint(s) of evaluation of this end point: N/A
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Secondary ID(s)
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2010-023505-36-IT
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E2080-G000-303
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Source(s) of Monetary Support
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Eisai Ltd
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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