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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: 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
Address: 
Telephone:
Email:
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: Placebo capsule
Drug: Fingolimod
Primary Outcome(s)
Frequency of Relapses in Patients Treated for up to 24 Months [Time Frame: 24 months]
Secondary Outcome(s)
Pharmacokinetic/Pharmacodynamic Relationship for Fingolimod-P to Lymphocyte Levels [Time Frame: 24 months]
T1 Gd- Enhancing Lesions [Time Frame: 24 months]
New/Newly Enlarged T2 Lesions [Time Frame: 24 months]
Time to First Relapse [Time Frame: 24 months]
Pharmacokinetics (Cavg) of Fingolimod-P [Time Frame: 24 months]
Proportion of Patients Relapse-free [Time Frame: 24 months]
Secondary ID(s)
2011-005677-23
CFTY720D2311
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 19/09/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01892722
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