Ofatumumab + Siponimod vs Fingolimod for Pediatric Multiple Sclerosis
(NEOS Trial)
Trial Summary
What is the purpose of this trial?
This trial tests three medications in children and teens with multiple sclerosis to find effective treatments. The drugs work by reducing harmful immune cells or preventing them from attacking the nervous system.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that Ofatumumab + Siponimod vs Fingolimod for Pediatric Multiple Sclerosis is an effective drug?
The available research shows that Fingolimod is an effective drug for treating pediatric multiple sclerosis. It has been approved for use in children with relapsing forms of the disease and has shown to reduce relapses significantly. However, there is no specific data provided on the combination of Ofatumumab + Siponimod for pediatric multiple sclerosis in the information available. Therefore, while Fingolimod is supported by research as effective, there is no direct comparison or data for Ofatumumab + Siponimod in the context of pediatric multiple sclerosis.12345
What data supports the effectiveness of the drug Fingolimod for pediatric multiple sclerosis?
Fingolimod has been shown to be effective in reducing relapses in children with relapsing-remitting multiple sclerosis, as confirmed by real-world data from two case reports. It was approved for use in children by the FDA and European Medicines Agency, demonstrating its effectiveness in this age group.12345
What safety data exists for Ofatumumab, Siponimod, and Fingolimod in treating pediatric multiple sclerosis?
Is the drug Fingolimod, Ofatumumab, Siponimod a promising treatment for Pediatric Multiple Sclerosis?
Yes, Ofatumumab and Siponimod are promising drugs for treating multiple sclerosis. Ofatumumab is effective in reducing relapse rates and slowing disability progression, and it can be self-administered, offering convenience. Siponimod has shown significant benefits in slowing disease progression compared to other treatments. Both drugs have been shown to be effective in managing multiple sclerosis symptoms.1112131415
What makes the drug combination of Ofatumumab, Siponimod, and Fingolimod unique for treating pediatric multiple sclerosis?
Research Team
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
This trial is for children and teenagers aged 10 to less than 18 with multiple sclerosis (MS). They should have had at least one MS attack in the past year or two attacks in the last two years, or new brain lesions on MRI within a year. Those with progressive MS, other immune diseases, severe heart or kidney problems can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Core Part
24-month, double-blind, triple dummy, randomized, 3-arm active-controlled study in children/adolescent patients with Multiple Sclerosis
Extension Part
60-month open label treatment for patients who complete the Core Part of the study
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fingolimod
- Ofatumumab
- Siponimod
Fingolimod is already approved in European Union, United States, Canada for the following indications:
- Relapsing forms of multiple sclerosis
- Relapsing forms of multiple sclerosis
- Relapsing forms of multiple sclerosis
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Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD