Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 May 2025
• Main ID: NCT01892722
• Date of registration: 08/05/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
• Scientific title: A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon ß-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase
• Date of first enrolment: July 26, 2013
• Target sample size: 240
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01892722
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Estonia, France, Germany, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Key Inclusion Criteria Core Phase:

- diagnosis of multiple sclerosis

- at least one MS relapse during the previous year or two MS relapses in the previous
2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0
to 5.5, inclusive

Key Exclusion Criteria Core Phase:

- patients with progressive MS

- patients with an active, chronic disease of the immune system other than MS

- patients meeting the definition of ADEM

- patients with severe cardiac disease or significant findings on the screening ECG.

- patients with severe renal insufficiency

Key Inclusion Criteria Extension Phase:

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.

Key Exclusion Criteria Extension Phase:

Applies to patients who completed the Core Phase, but prematurely discontinued study
drug.

1. 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

2. 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.

1. All newly recruited patients in the younger cohort that enroll directly into the
Extension Phase must fulfill the exclusion criteria for the core phase.


Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Interferon beta-1a

Drug: Placebo i.m. injection

Drug: Fingolimod

Drug: Placebo capsule

Primary Outcome(s)

Frequency of Relapses in Patients Treated for up to 24 Months [Time Frame: 24 months]

Secondary Outcome(s)

Pharmacokinetics (Cavg) of Fingolimod-P [Time Frame: 24 months]

Proportion of Patients Relapse-free [Time Frame: 24 months]

New/Newly Enlarged T2 Lesions [Time Frame: 24 months]

Pharmacokinetic/Pharmacodynamic Relationship for Fingolimod-P to Lymphocyte Levels [Time Frame: 24 months]

T1 Gd- Enhancing Lesions [Time Frame: 24 months]

Time to First Relapse [Time Frame: 24 months]

Secondary ID(s)

2011-005677-23

CFTY720D2311

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01892722