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Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

NCT04926818

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Multiple Sclerosis (MS)

Interventions: Fingolimod, Ofatumumab, Siponimod, Fingolimod placebo, Siponimod placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

Eligibility overview

Sex: ALL

Age: 10 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Between 10 to \<18 years of age (i.e., have not yet had their 18th birthday) at randomization
2. Diagnosis of multiple sclerosis
3. EDSS score of 0 to 5.5, inclusive
4. At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months

Exclusion Criteria:

1. Participants with progressive MS
2. Participants with an active, chronic disease of the immune system other than MS
3. Participants meeting the definition of ADEM
4. Participants with severe cardiac disease or significant findings on the screening ECG.
5. Participants with severe renal insufficiency
Locations (51)
  • Little Rock, Arkansas, United States
  • Los Angeles, California, United States
  • Washington D.C., District of Columbia, United States
  • Tampa, Florida, United States
  • Philadelphia, Pennsylvania, United States
  • Milwaukee, Wisconsin, United States
  • CABA, Argentina
  • Parkville, Victoria, Australia
  • Vienna, Austria
  • Esneux, Belgium
  • Ghent, Belgium
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, São Paulo, Brazil
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Lo Barnechea, Santiago Metropolitan, Chile
  • Zagreb, Croatia
  • Tallinn, Estonia
  • Le Kremlin-Bicêtre, France
  • Montpellier, France
  • Strasbourg, France
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Göttingen, Lower Saxony, Germany
  • Bochum, Germany
  • Guatemala City, Guatemala
  • New Delhi, National Capital Territory of Delhi, India
  • Lucknow, Uttar Pradesh, India
  • Kolkata, West Bengal, India
  • Petah Tikva, Israel
  • + 21 more on CT.gov