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Immunomodulator

Fingolimod for Pediatric Multiple Sclerosis

Q: What disease does Fingolimod typically help patients manage?

Fingolimod is an effective medication for treating secondary progressive <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a> (spms), multiple sclerosis, and carcinoma in situ.

Q: Has Fingolimod undergone drug approval by the FDA?

Fingolimod's safety is rated a 3 by our team at Power. This is due to the fact that it is a Phase 3 trial, so while there is some evidence of efficacy, there is also robust evidence indicating that it is safe.

Q: Does this experiment still need participants?

That is correct. According to the listing on clinicaltrials.gov, this study is currently looking for enrollees. The trial was first posted on 7/26/2013, with the most recent update being on 10/25/2022. There is a total of 220 patients that need to be recruited, and there is 1 location associated with the trial.

Q: How many human guinea pigs are enrolled in this clinical trial?

That is correct. The trial, which is currently enrolling 220 patients at 1 site, was first posted on 7/26/2013. The most recent update was on 10/25/2022.

Q: Does this experiment only require people who are 75 years old or younger?

The age range that is eligible for this trial is between 10-17 years old.

Q: Are there other examples of Fingolimod being used in a medical trial?

There are a total of 19 clinical trials studying the efficacy of fingolimod. Of these, 11 are in phase 3. The primary location for these studies is Bordeaux, RS; however, there are 1,630 total sites running these trials.

Q: What is unique about this research?

Fingolimod has been under medical scrutiny since 2008. In that year, the first trial was completed with Roche Pharma AG sponsoring the research. 220 people were included the trial. After the success of the Phase 1 trial, Fingolimod received approval for Phase 2 testing. Presently, there are 19 active trials being conducted in 531 cities and 58 countries.

Q: How can I sign up to be a test subject in this experiment?

We are looking for 220 young patients, aged 10-17, that have a medical diagnosis of <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>. Additionally, they must have experienced a relapse in the last year or two relapses in the previous two years. Another way to qualify for this study is to have evidence of Gd enhancing lesions on <a href="https://www.withpower.com/clinical-trials/mri">MRI</a> within the last 6 months. Lastly, their EDSS score must be between 0 and 5.5.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study 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).Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of Relapses in Patients Treated for up to 24 Months

Secondary outcome measures

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

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,863 Previous Clinical Trials

4,198,854 Total Patients Enrolled

100 Trials studying Multiple Sclerosis

51,892 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What disease does Fingolimod typically help patients manage?

"Fingolimod is an effective medication for treating secondary progressive multiple sclerosis (spms), multiple sclerosis, and carcinoma in situ."

Answered by AI

Has Fingolimod undergone drug approval by the FDA?

"Fingolimod's safety is rated a 3 by our team at Power. This is due to the fact that it is a Phase 3 trial, so while there is some evidence of efficacy, there is also robust evidence indicating that it is safe."

Answered by AI

Does this experiment still need participants?

"That is correct. According to the listing on clinicaltrials.gov, this study is currently looking for enrollees. The trial was first posted on 7/26/2013, with the most recent update being on 10/25/2022. There is a total of 220 patients that need to be recruited, and there is 1 location associated with the trial."

Answered by AI

How many human guinea pigs are enrolled in this clinical trial?

"That is correct. The trial, which is currently enrolling 220 patients at 1 site, was first posted on 7/26/2013. The most recent update was on 10/25/2022."

Answered by AI

Does this experiment only require people who are 75 years old or younger?

"The age range that is eligible for this trial is between 10-17 years old."

Answered by AI

Are there other examples of Fingolimod being used in a medical trial?

"There are a total of 19 clinical trials studying the efficacy of fingolimod. Of these, 11 are in phase 3. The primary location for these studies is Bordeaux, RS; however, there are 1,630 total sites running these trials."

Answered by AI

What is unique about this research?

"Fingolimod has been under medical scrutiny since 2008. In that year, the first trial was completed with Roche Pharma AG sponsoring the research. 220 people were included the trial. After the success of the Phase 1 trial, Fingolimod received approval for Phase 2 testing. Presently, there are 19 active trials being conducted in 531 cities and 58 countries."

Answered by AI

How can I sign up to be a test subject in this experiment?

"We are looking for 220 young patients, aged 10-17, that have a medical diagnosis of multiple sclerosis. Additionally, they must have experienced a relapse in the last year or two relapses in the previous two years. Another way to qualify for this study is to have evidence of Gd enhancing lesions on MRI within the last 6 months. Lastly, their EDSS score must be between 0 and 5.5."

Answered by AI

Recent research and studies

msJournal

Consistent Control of Disease Activity with Fingolimod Versus IFN Β-1a in Paediatric-onset Multiple Sclerosis: Further Insights from Paradigms

Deiva, Kumaran, Peter Huppke, Brenda Banwell, Tanuja Chitnis, Jutta Gärtner, Lauren Krupp, Emmanuelle Waubant, Tracy Stites, Gregory Lewis Pearce, and Martin Merschhemke. 2019. “Consistent Control of Disease Activity with Fingolimod Versus IFN Β-1a in Paediatric-onset Multiple Sclerosis: Further Insights from Paradigms”. Journal of Neurology, Neurosurgery & Psychiatry. BMJ. doi:10.1136/jnnp-2019-321124.

New England Journal of MedicineJournal

Trial of Fingolimod Versus Interferon Beta-1a in Pediatric Multiple Sclerosis

Chitnis, Tanuja, Douglas L. Arnold, Brenda Banwell, Wolfgang Brück, Angelo Ghezzi, Gavin Giovannoni, Benjamin Greenberg, et al.. 2018. “Trial of Fingolimod Versus Interferon Beta-1a in Pediatric Multiple Sclerosis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1800149.

clinicaltrials.govStudy

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

2013. "Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01892722.

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