What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) that inhibit immune cell activity, such as Teriflunomide, can have several side effects. Teriflunomide may cause liver enzyme elevation, gastrointestinal issues, and potential teratogenic effects. Fingolimod, another similar treatment, can lead to bradyarrhythmia, macular edema, liver injury, and increased risk of infections. Interferon beta treatments often result in flu-like symptoms, injection site reactions, and liver enzyme abnormalities. Glatiramer acetate is generally well-tolerated but can cause injection site reactions and, in rare cases, hepatotoxicity.

What prior FDA approvals exist?

Teriflunomide, an oral immunomodulatory drug that inhibits dihydroorotate dehydrogenase to reduce lymphocyte proliferation, is FDA-approved for the treatment of relapsing forms of Multiple Sclerosis (MS). Similar FDA-approved treatments include Dimethyl Fumarate (BG-12), which modulates the immune response and has shown efficacy in reducing relapse rates and new brain lesions. Another related drug is Fingolimod, which sequesters lymphocytes in lymph nodes, preventing them from contributing to an autoimmune reaction. Additionally, Glatiramer Acetate, an injectable drug, mimics myelin basic protein to modulate the immune response. These treatments, along with Teriflunomide, offer various mechanisms to manage MS by targeting different aspects of the immune system.

What other types of research exist?

Promising novel alternatives to Teriflunomide for Multiple Sclerosis patients include: <ol> <li>Dimethyl Fumarate (BG-12): Shown to significantly reduce relapse rates and new brain lesions in clinical trials.</li> <li>Alemtuzumab: Effective in reducing relapse rates and is generally reserved for patients with highly active MS.</li> <li>Ocrelizumab: A monoclonal antibody that targets CD20-positive B cells, effective in reducing relapse rates and disability progression.</li> <li>Siponimod: An S1P receptor modulator effective in reducing relapse rates and disability progression, particularly in secondary progressive MS.</li> <li>Cladribine: An oral treatment that selectively targets lymphocytes, effective in reducing relapse rates and disability progression.</li> </ol>

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Immunomodulator

Teriflunomide for Pediatric Multiple Sclerosis (TERIKIDS Trial)

Phase 3

Waitlist Available

Research Sponsored by Genzyme, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Recent treatment with glatiramer acetate, interferons, or dimethyl fumarate, fingolimod, or intravenous immunoglobulins, natalizumab, other immunosuppressant or immunomodulatory agents, cladribine, mitoxantrone, or alemtuzumab

Female participants of child-bearing potential not using highly effective contraceptive method

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, db period: weeks 24, 48, 72 and 96; ol period: weeks 24, 48, 72, 96, 120, 144, 168 and 192

Awards & highlights

Pivotal Trial

Summary

This trial tests teriflunomide, a medication that calms the immune system, in children and adolescents with relapsing multiple sclerosis. The goal is to see if it can reduce the frequency of MS relapses. Teriflunomide is an oral therapy that has shown effectiveness in reducing relapse rates and slowing disease progression in multiple sclerosis patients.

Who is the study for?

This trial is for children and adolescents aged 10 to 17 with relapsing forms of multiple sclerosis (MS) who've had at least one MS attack in the past year or two in the last two years. They must not have severe disability from MS, haven't used certain MS drugs recently, can undergo MRI scans, and aren't pregnant.

What is being tested?

The trial tests Teriflunomide against a placebo to see if it reduces the time until a child's next MS relapse. It also looks at how the drug affects brain lesions seen on MRI and cognitive function while checking its safety and how it's processed by young bodies.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with Teriflunomide include liver problems, hair thinning, nausea, diarrhea, numbness or tingling in hands or feet. The study will monitor these and other potential side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have recently been treated with specific MS medications or immune system therapies.

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I am a woman able to have children and am not using strong birth control.

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I have a history of HIV infection.

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My disability score is over 5.5.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, db period: weeks 24, 48, 72 and 96; ol period: weeks 24, 48, 72, 96, 120, 144, 168 and 192

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, db period: weeks 24, 48, 72 and 96; ol period: weeks 24, 48, 72, 96, 120, 144, 168 and 192

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, db period: weeks 24, 48, 72 and 96; ol period: weeks 24, 48, 72, 96, 120, 144, 168 and 192 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to First Confirmed Clinical Relapse

Secondary study objectives

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan

Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions

Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192

+18 more

Side effects data

From 2015 Phase 4 trial • 1001 Patients • NCT01895335

23%

Alopecia

17%

Diarrhoea

Nausea

Headache

Urinary Tract Infection

Alanine Aminotransferase Increased

Fatigue

Nasopharyngitis

Multiple Sclerosis Relapse

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Teriflunomide

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TeriflunomideExperimental Treatment1 Intervention

Teriflunomide oral tablet, three dosages (3.5, 7 or 14 mg) to reach 14 mg adult equivalent

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo tablets

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Teriflunomide

2008

Completed Phase 4

~7100

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) work by modulating the immune system to reduce its attack on the nervous system. Teriflunomide, for example, inhibits dihydroorotate dehydrogenase to reduce lymphocyte proliferation, limiting immune system activity. Interferon beta modulates immune response and reduces inflammation, while glatiramer acetate mimics myelin basic protein to divert immune attacks away from actual myelin. These mechanisms are crucial for MS patients as they help decrease relapse frequency and severity, slow disease progression, and manage symptoms, thereby improving overall quality of life.