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Clinical Trials in the UK / NCT01892722
Active, not recruiting Phase 3

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

NCT01892722 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2013-07-26
Last updated
2026-08-10

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Interferon beta-1aFingolimodPlacebo capsulePlacebo i.m. injection

Interferon beta-1a: Administration once weekly via i.m. injections.

Fingolimod: Administrated orally once daily: 0.5 mg capsule for patients over 40 kg or 0.25 mg capsule for patients 40 kg or less.

Placebo capsule: Matching placebo capsule required for double-dummy masking to blind formulations.

Placebo i.m. injection: Matching placebo i.m. injection required for double-dummy masking to blind formulations.

Study summary

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

Eligibility

Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
UAB Childrens Hospital Harbor Center Neurology Dept Birmingham Alabama
Childrens Hospital Los Angeles Los Angeles California
UCSF San Francisco California
University of Miami Miami Florida
AMO Corporation Tallahassee Florida
Massachusetts General Hospital Boston Massachusetts
Wayne State University Detroit Michigan
Robert Wood Johnson Medical School New Brunswick New Jersey
Childrens Hospital of Philadelphia Philadelphia Pennsylvania
University of Utah Clinical Trials Office Salt Lake City Utah
Novartis Investigative Site Parkville Victoria
Novartis Investigative Site Vienna Austria
Novartis Investigative Site Belo Horizonte Minas Gerais
Novartis Investigative Site Rio de Janeiro Rio de Janeiro
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site Goiânia Brazil
Novartis Investigative Site Sofia Bulgaria
Novartis Investigative Site Calgary Alberta
Novartis Investigative Site Ottawa Ontario
Novartis Investigative Site Osijek Croatia
Novartis Investigative Site Tallinn Estonia
Novartis Investigative Site Bordeaux France
Novartis Investigative Site Le Kremlin-Bicêtre France
Novartis Investigative Site Marseille France
Novartis Investigative Site Montpellier France
Novartis Investigative Site Toulouse France
Novartis Investigative Site Freiburg im Breisgau Baden-Wurttemberg
Novartis Investigative Site Göttingen Lower Saxony
Novartis Investigative Site Dresden Saxony
Novartis Investigative Site Bochum Germany
Novartis Investigative Site Erlangen Germany
Novartis Investigative Site Bari BA
Novartis Investigative Site Montichiari BS
Novartis Investigative Site Catania CT
Novartis Investigative Site Milan MI
Novartis Investigative Site Cefalù PA
Novartis Investigative Site Roma RM
Novartis Investigative Site Roma RM
Novartis Investigative Site Gallarate VA
Novartis Investigative Site Riga Latvia

+ 33 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01892722 on ClinicalTrials.gov ↗ ← All trials in the UK