Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

  • STATUS
    Recruiting
  • End date
    Dec 16, 2028
  • participants needed
    220
  • sponsor
    Novartis Pharmaceuticals
Updated on 24 September 2021
interferon
MRI
fingolimod

Summary

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

Description

The study is divided into a Core Phase, which includes the Double-Blind Treatment Period, and an Extension Phase in which all patients will be treated with fingolimod. The Core Phase is a 24-month, double-blind, randomized, active-controlled, parallel-group multicenter study phase to evaluate the efficacy and safety of fingolimod compared to IFN -1a in children/adolescent patients aged 10-17 years old with MS. The Extension Phase is a 60-month (5 year) study phase for patients who complete the Core Phase of the study and meet all inclusion/exclusion criteria and for patients who will be recruited in the younger cohort to participate in the Extension Phase. The 'younger cohort' refers to the population of pediatric patients fulfilling any single one or a combination of the following criteria: being 12 years of age, or weighing 40 kg, or being prepubertal (i.e. pubertal status of Tanner stage <2). The recruitment of the younger cohort (30 patients) was requested as a post- approval health authority commitment

Details
Condition Multiple Sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave, multiple sclerosis (ms)
Treatment Placebo Capsule, Interferon beta-1a i.m. injections, Fingolimod oral capsules, Placebo oral capsule, Placebo i.m. injection, Fingolimod, Interferon beta-1a
Clinical Study IdentifierNCT01892722
SponsorNovartis Pharmaceuticals
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Applies to all patients participating in the Core Phase and then entering the
Extension Phase. 1. Patients that originally met Core Phase Inclusion criteria
and completed the Core phase on or off of study drug
Applies to patients newly recruited to participate in the Extension Phase
All newly recruited patients' that enroll directly into the Extension Phase must fulfill the local country health authority product label approved for pediatric age group for inclusion criteria
Central review (including initial MRI report) of the diagnosis of pediatric MS will be required for all newly recruited patients

Exclusion Criteria

Applies to patients who completed the Core Phase, but prematurely discontinued
study drug
Premature discontinuation of the study drug during the Core Phase due to
an adverse event
serious adverse event
laboratory abnormality
other conditions leading to permanent study drug discontinuation due to safety reasons
Patients with known new events or concomitant medications (washout periods required prior to Visit 15) that would exclude them from the Core Phase exclusion criteria. Serological or other additional tests will not be required
Applies to patients newly recruited in the younger cohort to participate in
the Extension Phase
All newly recruited patients in the younger cohort that enroll directly into the Extension Phase must fulfill the exclusion criteria for the core phase
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