drugset / Trial / NCT01892722
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
RandomizedParallel-groupDouble-blindTreatment
Summary
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)
Timeline
- Start
- 2013-07-26
- Primary completion
- 2017-07-14
- Completion
- 2030-02-18
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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fingolimod | Small molecule | 0.25 mg | Oral |
| Subject | Fingolimod | Small molecule | 0.5 mg | Oral |
| Comparator | Interferon beta-1a | Protein / enzyme biologic | 30 ug | Intramuscular |