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Dimethyl Fumarate for Multiple Sclerosis (CONNECT Trial)
CONNECT Trial Summary
This trial is testing the safety and effectiveness of BG00012 in children with RRMS, compared to another disease-modifying treatment. The long-term safety of BG00012 will also be assessed in children who completed Week 96 in Part 1 of the study.
CONNECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCONNECT Trial Timeline
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 • 241 Patients • NCT02090413CONNECT Trial Design
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Who is running the clinical trial?
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- I have a history of HIV.I do not have conditions that can be confused with MS like lupus or metabolic disorders.I had skin cancer but it was fully removed.I do not have any major health issues that would stop me from joining a study.I have had an MS flare-up within the last 50 days or haven't recovered from a recent one.I have previously taken Fumaderm or BG00012.I have not had specific immune system treatments, except possibly rituximab or natalizumab.I haven't taken steroids or certain nerve medications in the last 30 days.My body weight is at least 30 kg.I have been diagnosed with relapsing-remitting MS.I have had MS relapses or new brain lesions recently.I haven't had a neurological relapse or taken steroids in the last 50 days.I cannot swallow the BG00012 capsule whole.I haven't taken mitoxantrone, cyclophosphamide, or rituximab in the last year.I haven't taken specific immune system affecting drugs or had certain blood treatments in the last 6 months.My MS is in a progressive stage.I can walk without help, with a disability score up to 5.5.
- Group 1: IFN β-1a (Avonex)
- Group 2: BG00012
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 are the common applications for dimethyl fumarate?
"Multiple sclerosis, parenteral drug administration, and other conditions can benefit from therapy using dimethyl fumarate."
What are the volunteers' specific characteristics for this research project?
"This study is testing an experimental medication for multiple sclerosis in children aged 10-17. Around 156 patients will be enrolled at clinical sites around the world."
Has dimethyl fumarate been cleared for use by the FDA?
"There is some evidence to support the efficacy of dimethyl fumarate, as this drug is currently in Phase 3 trials. Furthermore, multiple rounds of testing have concluded that dimethyl fumarate is safe for human use, and it received a score of 3."
Does this study have an age limit, and if so, what is it?
"This particular clinical trial is for patients aged 10-17. Out of the 52 clinical trials conducted for minors, this one is specific to 416 adults over 65 years old."
Can patients still enroll in this research project?
"Currently, this clinical trial is not seeking new patients. The study was first posted on 8/28/2014 and the most recent update occurred on 1/12/2022. However, there are 563 other trials related to multiple sclerosis that are actively enrolling candidates as well as 24 for dimethyl fumarate."
How many people are subjects in this clinical trial?
"Unfortunately, this particular clinical trial is no longer actively recruiting patients. The study was originally posted on 8/28/2014 but has not been updated since 1/12/2022. However, there are 563 other trials for multiple sclerosis and 24 dimethyl fumarate trials that may be of interest and are currently looking for participants."
Could you please walk me through other scientific research that has been done on dimethyl fumarate?
"Since 2007, when dimethyl fumarate was first studied at Children's Hospital of Geneva (HUG), there have been a total of 269 completed clinical trials. There are presently 24 active trials, with locations in Calgary and Massachusetts being most prevalent."
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