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Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

NCT01892722 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-11-20

Study results available
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Summary

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

Conditions

Interventions

DRUG

Interferon beta-1a

Administration once weekly via i.m. injections.

DRUG

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.

DRUG

Placebo capsule

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

DRUG

Placebo i.m. injection

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-26
Primary Completion
2017-07-14
Completion
2030-02-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • Estonia
  • France
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01892722 on ClinicalTrials.gov