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Fingolimod for Pediatric Multiple Sclerosis
Study Summary
This trial looks at whether fingolimod is safe and effective for kids with MS, compared to interferon beta-1a.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 42 Patients • NCT01578330Trial Design
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Who is running the clinical trial?
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- I am not taking any medications or have conditions that would exclude me from this study.I do not have severe heart disease or major issues on my heart test.I have severe kidney problems.I stopped taking the study drug early due to a serious side effect or lab result.My multiple sclerosis is getting worse.I have been diagnosed with ADEM.I meet the exclusion criteria for the initial phase of the study.I have been diagnosed with multiple sclerosis.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.My disability score is between 0 and 5.5.I completed the initial part of the study, with or without the study drug.I have a chronic immune system disease other than MS.
- Group 1: Fingolimod-Younger Cohort
- Group 2: Fingolimod
- Group 3: Interferon beta-1a
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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