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Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i. m.
in pediatric patients with multiple sclerosis (MS).
Study details:
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 β-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 (up to 25 patients) was requested as a post- approval health authority commitment.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 10 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2013-07-26
Primary completion: 2017-07-14
Study completion finish: 2029-07-12
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT01892722
Intervention or treatment
DRUG: Interferon beta-1a
DRUG: Fingolimod
DRUG: Placebo capsule
DRUG: Placebo i.m. injection
Conditions
- • Multiple Sclerosis
Find a site
Closest Location:
Novartis Investigative Site
Research sites nearby
Select from list below to view details:
Novartis Investigative Site
Parkville, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Fingolimod
| DRUG: Fingolimod
|
ACTIVE_COMPARATOR: Interferon beta-1a
| DRUG: Interferon beta-1a
|
EXPERIMENTAL: Fingolimod-Younger Cohort
| DRUG: Fingolimod
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Frequency of Relapses in Patients Treated for up to 24 Months | Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25). | 24 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
New/Newly Enlarged T2 Lesions | Annualized rate of the number of new/newly enlarged T2 lesions up to Month 24 | 24 months |
Time to First Relapse | Time to first relapse was determined. | 24 months |
Proportion of Patients Relapse-free | Proportion of patients relapse-free was determined | 24 months |
T1 Gd- Enhancing Lesions | Number of T1 Gd-enhancing lesions per scan up to Month 24 | 24 months |
Pharmacokinetics (Cavg) of Fingolimod-P | Cavg (average drug concentration over the dose interval) will be evaluated. | 24 months |
Pharmacokinetic/Pharmacodynamic Relationship for Fingolimod-P to Lymphocyte Levels | Population PK/PD modeling approaches were used to relate the individual fingolimod-P concentrations to lymphocyte counts. | 24 months |
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