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Immunomodulator

Fingolimod for Pediatric Multiple Sclerosis

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Patients with severe cardiac disease or significant findings on the screening ECG
Patients with severe renal insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trial looks at whether fingolimod is safe and effective for kids with MS, compared to interferon beta-1a.

Who is the study for?
This trial is for children with multiple sclerosis (MS) who've had at least one MS relapse in the past year or two in the last two years, or recent MRI evidence of active lesions. They should be able to perform daily activities with minimal assistance (EDSS score 0-5.5).
What is being tested?
The study compares the safety and effectiveness of a drug called Fingolimod against Interferon beta-1a in pediatric MS patients. Some participants will receive Fingolimod while others will get Interferon beta-1a injections; there's also a placebo group.
What are the potential side effects?
Fingolimod may cause headaches, flu-like symptoms, back pain, diarrhea, liver enzyme increases, coughs and infections. Interferon beta-1a can lead to injection site reactions, flu-like symptoms, depression and blood cell count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with multiple sclerosis.
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I have had at least one MS flare-up in the last year or two in the last two years, or recent MRI shows active MS.
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My disability score is between 0 and 5.5.
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I completed the initial part of the study, with or without the study drug.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart disease or major issues on my heart test.
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I have severe kidney problems.
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I stopped taking the study drug early due to a serious side effect or lab result.
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My multiple sclerosis is getting worse.
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I have been diagnosed with ADEM.
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I meet the exclusion criteria for the initial phase of the study.
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I have a chronic immune system disease other than MS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of Relapses in Patients Treated for up to 24 Months
Secondary study objectives
New/Newly Enlarged T2 Lesions
Pharmacokinetic/Pharmacodynamic Relationship for Fingolimod-P to Lymphocyte Levels
Pharmacokinetics (Cavg) of Fingolimod-P
+3 more

Side effects data

From 2015 Phase 4 trial • 42 Patients • NCT01578330
21%
Urinary infection
19%
Upper respiratory infection
17%
Lymphopenia
12%
Increase of hepatic enzymes
10%
Multiple Sclerosis Aggravated
10%
Headache
10%
Hyperlipidemia
7%
Tooth abscess
7%
Nausea
7%
Incontinence
2%
Fracture
2%
Medication taken before pregnancy
2%
Middle ear infection surgery
2%
Multiple Sclerosis aggravated
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fingolimod, FTY720

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Fingolimod-Younger CohortExperimental Treatment1 Intervention
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)
Group II: FingolimodExperimental Treatment2 Interventions
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
Group III: Interferon beta-1aActive Control2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fingolimod
2012
Completed Phase 4
~11330
Placebo capsule
2015
Completed Phase 4
~5270

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,759 Total Patients Enrolled
104 Trials studying Multiple Sclerosis
51,565 Patients Enrolled for Multiple Sclerosis

Media Library

Fingolimod (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT01892722 — Phase 3
Multiple Sclerosis Research Study Groups: Fingolimod-Younger Cohort, Fingolimod, Interferon beta-1a
Multiple Sclerosis Clinical Trial 2023: Fingolimod Highlights & Side Effects. Trial Name: NCT01892722 — Phase 3
Fingolimod (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01892722 — Phase 3
~20 spots leftby Sep 2025
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