Study on the Safety and Effectiveness of Dimethyl Fumarate for Children Aged 10-17 with Relapsing-Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying a condition known as Relapsing-Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis characterized by periods of new or increasing symptoms followed by periods of improvement or stability. The study is testing a treatment called TECFIDERA, which contains the active ingredient dimethyl fumarate. This medication is taken orally in the form of a hard capsule.

The purpose of the study is to evaluate the safety and effectiveness of TECFIDERA in children aged 10 to less than 18 years who have RRMS. Participants will be randomly assigned to receive either TECFIDERA or another treatment that modifies the disease. The study will also include an optional extension phase where participants can continue to receive TECFIDERA to assess its long-term safety. Throughout the study, participants will undergo regular check-ups and MRI scans to monitor the progression of the disease and any changes in their condition.

The study will last for several years, with the first part focusing on the initial 96 weeks. During this time, the main goal is to see how well the treatment works in preventing new brain lesions, which are areas of damage in the brain that can be seen on an MRI scan. The second part of the study will continue to monitor participants who completed the first part, focusing on the long-term safety of the treatment. Participants will be closely monitored for any side effects or adverse events, and their overall health and quality of life will be assessed throughout the study.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying a diagnosis of relapsing-remitting multiple sclerosis (RRMS) and ensuring a body weight of at least 30 kg.

A baseline evaluation will be performed, including a neurological examination to determine the Expanded Disability Status Scale (EDSS) score, which should be between 0 and 5.5.

2 treatment phase part 1

Participants will begin the treatment phase, receiving the medication TECFIDERA (dimethyl fumarate) in the form of a hard capsule taken orally.

The dosage and frequency of administration will be determined by the study protocol, and participants will be monitored for safety and efficacy over a period of 96 weeks.

3 regular monitoring

Throughout the study, regular monitoring will occur, including brain MRI scans at weeks 24, 48, and 96 to assess for new or enlarging lesions.

Participants will also be evaluated for any relapses, changes in disability status, and any adverse events such as flushing, nausea, abdominal pain, or diarrhea.

4 completion of part 1

At the end of 96 weeks, participants will complete part 1 of the study. The primary endpoint is the proportion of participants free of new or enlarging lesions on brain MRI scans.

Secondary endpoints include the number of new lesions, time to first relapse, and changes in fatigue and disability scores.

5 optional extension phase

Participants who complete part 1 may enter an optional open-label extension phase to evaluate the long-term safety of TECFIDERA.

During this phase, continued monitoring of health outcomes, including relapse rates and changes in cognitive function, will be conducted.

Who Can Join the Study?

Must have a body weight of at least 30 kg (about 66 pounds).
Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis where symptoms flare up and then improve.
Must be able to walk, with a baseline EDSS score between 0 and 5.5. The EDSS score is a way to measure disability in people with multiple sclerosis, where 0 means no disability and 5.5 means moderate disability.
Must have had at least 1 relapse (flare-up of symptoms) in the last 12 months or at least 2 relapses in the last 24 months, with a previous brain MRI showing lesions (damaged areas) consistent with multiple sclerosis, or evidence of Gd enhancing lesions on a brain MRI done within 6 weeks before starting the study. Gd enhancing lesions are areas of active inflammation in the brain that show up on MRI scans when a special dye is used.
Must be neurologically stable, meaning no new relapses within 50 days before starting the study and no treatment with corticosteroids (a type of medication used to reduce inflammation) within 30 days before starting the study.
If able to have children and sexually active, must agree to use effective birth control during the study and for at least 30 days after the last dose of the study treatment.
For Part 2 of the study: Must have completed Week 96 in Part 1 of the study.

Who Cannot Join the Study?

Patients who have a different type of multiple sclerosis other than Relapsing-Remitting Multiple Sclerosis cannot participate.
Patients who have not completed week 96 in Part 1 of Study 109MS306 are excluded.
Patients who have not been evaluated for the safety, tolerability, and efficacy of the treatment in Part 1 are not eligible.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to provide informed consent or are part of a vulnerable population may be excluded.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hcurgiwb Ukiebgkxlxxssx Skqeiswoji &qmkgpb Hxufaeh do Hoeribrwyqr	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	28.08.2014

Trial locations

Investigated drugs:

Dimethyl Fumarate

BG00012 is a medication being studied for its effects on children with a type of multiple sclerosis called relapsing-remitting multiple sclerosis (RRMS). This medication is also known as dimethyl fumarate. It is used to help reduce the number of flare-ups or relapses that people with RRMS experience. The study aims to see how safe and effective this medication is in managing the disease and improving the overall health and disability outcomes of the participants. The trial also includes a long-term safety evaluation for those who continue the treatment after the initial study period.

Investigated diseases:

Relapsing-remitting multiple sclerosis

Relapsing-Remitting Multiple Sclerosis – This is a type of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During relapses, inflammation damages the protective covering of nerve fibers in the central nervous system, leading to symptoms such as fatigue, numbness, vision problems, and difficulty with coordination and balance. The disease progresses with these relapses, but between episodes, the disease does not seem to worsen. Over time, some people may experience a gradual worsening of symptoms, even during periods of remission. The frequency and severity of relapses can vary widely among individuals. The condition is unpredictable, with some people experiencing frequent relapses and others having long periods of stability.

Trial ID:

2023-505632-35-00

Protocol code:

109MS306

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Dimethyl Fumarate for Children Aged 10-17 with Relapsing-Remitting Multiple Sclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?