← Back to Search

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

Pivotal Trial

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

Select...

I have been diagnosed with multiple sclerosis.

Select...

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.

Select...

My disability score is between 0 and 5.5.

Select...

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:

Select...

I do not have severe heart disease or major issues on my heart test.

Select...

I have severe kidney problems.

Select...

I stopped taking the study drug early due to a serious side effect or lab result.

Select...

My multiple sclerosis is getting worse.

Select...

I have been diagnosed with ADEM.

Select...

I meet the exclusion criteria for the initial phase of the study.

Select...

I have a chronic immune system disease other than MS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Tooth abscess

Nausea

Incontinence

Fracture

Medication taken before pregnancy

Middle ear infection surgery

Multiple Sclerosis aggravated

100%

80%

60%

40%

20%

Study treatment Arm

Fingolimod, FTY720

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~5340