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ACTIVE NOT RECRUITING

NCT01892722

PHASE3

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Official title: A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2013-07-26

Completion Date

2030-02-18

Last Updated

2025-11-20

Healthy Volunteers

Conditions

Multiple Sclerosis

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.

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.

Locations (73)

UAB Childrens Hospital Harbor Center Neurology Dept

Birmingham, Alabama, United States

Childrens Hospital Los Angeles

Los Angeles, California, United States

UCSF

San Francisco, California, United States

University of Miami

Miami, Florida, United States

AMO Corporation

Tallahassee, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Utah Clinical Trials Office

Salt Lake City, Utah, United States

Novartis Investigative Site

Parkville, Victoria, Australia

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Goiânia, Brazil

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Ottawa, Ontario, Canada

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, Germany

Novartis Investigative Site

Göttingen, Lower Saxony, Germany

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Bochum, Germany

Novartis Investigative Site

Erlangen, Germany

Novartis Investigative Site

Bari, BA, Italy

Novartis Investigative Site

Montichiari, BS, Italy

Novartis Investigative Site

Catania, CT, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Cefalù, PA, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Gallarate, VA, Italy

Novartis Investigative Site

Riga, Latvia

Novartis Investigative Site

Kaunas, LTU, Lithuania

Novartis Investigative Site

Mexico City, D F, Mexico

Novartis Investigative Site

Distrito Federal, Mexico

Novartis Investigative Site

Rotterdam, South Holland, Netherlands

Novartis Investigative Site

Lodz, Poland

Novartis Investigative Site

Lublin, Poland

Novartis Investigative Site

Poznan, Poland

Novartis Investigative Site

Wroclaw, Poland

San Jorge Childrens Hospital

Santurce, Puerto Rico

Novartis Investigative Site

Bucharest, Romania

Novartis Investigative Site

Kazan', Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Novosibirsk, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Belgrade, Serbia

Novartis Investigative Site

Bratislava, Slovakia

Novartis Investigative Site

Seville, Andalusia, Spain

Novartis Investigative Site

Vigo, Pontevedra, Spain

Novartis Investigative Site

Barakaldo, Vizcaya, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Málaga, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Samsun, Atakum, Turkey (Türkiye)

Novartis Investigative Site

Izmir, Balcova, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Sihhiye-Altindag, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Novartis Investigative Site

Kharkiv, Ukraine

Novartis Investigative Site

West Midlands, Birmingham, United Kingdom

Novartis Investigative Site

Edinburgh, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Clinical Research Directory

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (73)