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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Novartis Pharmaceuticals 1-888-669-6682
Novartis.email@novartis.com


Novartis Pharmaceuticals +41613241111


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Be Part of Research - Trial Details - Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
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Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Recruiting

Open to: ALL

Age: 10.0 - 17.0

London West Midlands Edinburgh London

Medical Conditions

Multiple Sclerosis
Sclerosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2013 Jul 2017

Publications

"Deiva K, Huppke P, Banwell B, Chitnis T, Gartner J, Krupp L, Waubant E, Stites T, Pearce GL, Merschhemke M. Consistent control of disease activity with fingolimod versus IFN beta-1a in paediatric-onset multiple sclerosis: further insights from PARADIGMS. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):58-66. doi: 10.1136/jnnp-2019-321124. Epub 2019 Aug 29."; "31467033"; "Chitnis T, Arnold DL, Banwell B, Bruck W, Ghezzi A, Giovannoni G, Greenberg B, Krupp L, Rostasy K, Tardieu M, Waubant E, Wolinsky JS, Bar-Or A, Stites T, Chen Y, Putzki N, Merschhemke M, Gartner J; PARADIGMS Study Group. Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis. N Engl J Med. 2018 Sep 13;379(11):1017-1027. doi: 10.1056/NEJMoa1800149."; "30207920"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Administration once weekly via i.m. injections.

Intervention Arm Group : Interferon beta-1a;

Intervention Type : DRUG
Intervention Description : Administrated orally once daily:

0.5 mg capsule for patients over 40 kg or 0.25 mg capsule for patients 40 kg or less.

Intervention Arm Group : Fingolimod;Fingolimod-Younger Cohort;

Intervention Type : DRUG
Intervention Description : Matching placebo capsule required for double-dummy masking to blind formulations.

Intervention Arm Group : Fingolimod;

Intervention Type : DRUG
Intervention Description : Matching placebo i.m. injection required for double-dummy masking to blind formulations.

Intervention Arm Group : Interferon beta-1a;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Novartis Investigative Site
    London
    WC1N 3BG
  • Novartis Investigative Site
    West Midlands
    Birmingham
    B4 6NH
  • Novartis Investigative Site
    Edinburgh
    EH9 1LF
  • Novartis Investigative Site
    London
    WC1N 1EH

Novartis Pharmaceuticals 1-888-669-6682
Novartis.email@novartis.com


Novartis Pharmaceuticals +41613241111



The study is sponsored by Novartis Pharmaceuticals




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Read full details for Trial ID: NCT01892722
Last updated 09 July 2024

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