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Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Study Purpose

To evaluate the safety and efficacy of fingolimod vs.#46; interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	10 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Key Inclusion Criteria Core Phase:

- diagnosis of multiple sclerosis.

- at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive.

Key Exclusion Criteria Core Phase:

- patients with progressive MS.

- patients with an active, chronic disease of the immune system other than MS.

- patients meeting the definition of ADEM.

- patients with severe cardiac disease or significant findings on the screening ECG.

- patients with severe renal insufficiency.

Key Inclusion Criteria Extension Phase: Applies to all patients participating in the Core Phase and then entering the Extension Phase. 1. Patients that originally met Core Phase Inclusion criteria and completed the Core phase on or off of study drug. Applies to patients newly recruited to participate in the Extension Phase.

- All newly recruited patients' that enroll directly into the Extension Phase must fulfill the local country health authority product label approved for pediatric age group for inclusion criteria.

- Central review (including initial MRI report) of the diagnosis of pediatric MS will be required for all newly recruited patients.

Key Exclusion Criteria Extension Phase: Applies to patients who completed the Core Phase, but prematurely discontinued study drug. 1. Premature discontinuation of the study drug during the Core Phase due to:

- an adverse event, - serious adverse event, - laboratory abnormality.

- other conditions leading to permanent study drug discontinuation due to safety reasons.

2. Patients with known new events or concomitant medications (washout periods required prior to Visit 15) that would exclude them from the Core Phase exclusion criteria. Serological or other additional tests will not be required. Applies to patients newly recruited in the younger cohort to participate in the Extension Phase. 1. All newly recruited patients in the younger cohort that enroll directly into the Extension Phase must fulfill the exclusion criteria for the core phase.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01892722
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Croatia, Estonia, France, Germany, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis
Study Website:	View Trial Website

Additional Details

The study is divided into a Core Phase, which includes the Double-Blind Treatment Period, and an Extension Phase in which all patients will be treated with fingolimod. The Core Phase is a 24-month, double-blind, randomized, active-controlled, parallel-group multicenter study phase to evaluate the efficacy and safety of fingolimod compared to IFN β-1a in children/adolescent patients aged 10-17 years old with MS. The Extension Phase is a 60-month (5 year) study phase for patients who complete the Core Phase of the study and meet all inclusion/exclusion criteria and for patients who will be recruited in the younger cohort to participate in the Extension Phase. The 'younger cohort' refers to the population of pediatric patients fulfilling any single one or a combination of the following criteria: being ≤12 years of age, or weighing ≤40 kg, or being prepubertal (i.e. pubertal status of Tanner stage <2). The recruitment of the younger cohort (up to 25 patients) was requested as a post- approval health authority commitment

Arms & Interventions

Arms

Experimental: Fingolimod

Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose. Participants in this arm during core continued into extension and received open-label treatment

Active Comparator: Interferon beta-1a

An intramuscular (IM) injection of Interferon beta-1a was administered once weekly during core phase. Participants switched to receive open-label fingolimod in extension phase

Experimental: Fingolimod-Younger Cohort

The 'younger cohort' refers to the new pediatric patients to be recruited in the extension phase who fulfill any single one or a combination of the following criteria: being ≤12 years of age, or weighing ≤40 kg, or being prepubertal (i.e. pubertal status of Tanner stage <2)

Interventions

Drug: - Interferon beta-1a

Administration once weekly via i.m. injections.

Drug: - 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.

Drug: - Placebo capsule

Matching placebo capsule required for double-dummy masking to blind formulations.

Drug: - Placebo i.m. injection

Matching placebo i.m. injection required for double-dummy masking to blind formulations.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Birmingham, Alabama

Status

Completed

Address

Novartis Investigative Site

Birmingham, Alabama, 35294

Site Contact

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