Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
Condition(s) studied
Investigational drug(s) / intervention(s)
Interferon beta-1a: Administration once weekly via i.m. injections.
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.
Placebo capsule: Matching placebo capsule required for double-dummy masking to blind formulations.
Placebo i.m. injection: Matching placebo i.m. injection required for double-dummy masking to blind formulations.
Study summary
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)
Eligibility
Primary outcome measure(s)
- Frequency of Relapses in Patients Treated for up to 24 Months — 24 months
Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
Trial sites (73)
| Facility | City | Region | Status |
|---|---|---|---|
| UAB Childrens Hospital Harbor Center Neurology Dept | Birmingham | Alabama | |
| Childrens Hospital Los Angeles | Los Angeles | California | |
| UCSF | San Francisco | California | |
| University of Miami | Miami | Florida | |
| AMO Corporation | Tallahassee | Florida | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Wayne State University | Detroit | Michigan | |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | |
| University of Utah Clinical Trials Office | Salt Lake City | Utah | |
| Novartis Investigative Site | Parkville | Victoria | |
| Novartis Investigative Site | Vienna | Austria | |
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | |
| Novartis Investigative Site | São Paulo | São Paulo | |
| Novartis Investigative Site | Goiânia | Brazil | |
| Novartis Investigative Site | Sofia | Bulgaria | |
| Novartis Investigative Site | Calgary | Alberta | |
| Novartis Investigative Site | Ottawa | Ontario | |
| 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 | |
| Novartis Investigative Site | Göttingen | Lower Saxony | |
| Novartis Investigative Site | Dresden | Saxony | |
| Novartis Investigative Site | Bochum | Germany | |
| Novartis Investigative Site | Erlangen | Germany | |
| Novartis Investigative Site | Bari | BA | |
| Novartis Investigative Site | Montichiari | BS | |
| Novartis Investigative Site | Catania | CT | |
| Novartis Investigative Site | Milan | MI | |
| Novartis Investigative Site | Cefalù | PA | |
| Novartis Investigative Site | Roma | RM | |
| Novartis Investigative Site | Roma | RM | |
| Novartis Investigative Site | Gallarate | VA | |
| Novartis Investigative Site | Riga | Latvia |
+ 33 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in Mexico
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01892722 on ClinicalTrials.gov ↗ ← All trials in Mexico