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Immunomodulator

Dimethyl Fumarate for Multiple Sclerosis (CONNECT Trial)

Phase 3
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a body weight of ≥30 kg
Must have a diagnosis of RRMS (consensus definition for pediatric RRMS [Krupp 2007])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

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.

Who is the study for?
This trial is for kids over 30 kg with Relapsing-remitting Multiple Sclerosis (RRMS) who can walk and have had recent MS activity but no relapse or steroids in the last 50 days. They must not have other similar diseases, severe allergies to the drugs being tested, or any major health issues that could interfere with the study.Check my eligibility
What is being tested?
The trial tests BG00012 against a standard treatment for pediatric RRMS. It aims to see if BG00012 is safe, tolerable, and effective in managing symptoms and slowing disability progression over time compared to existing treatments.See study design
What are the potential side effects?
Possible side effects of dimethyl fumarate (BG00012) include flushing, stomach pain, diarrhea, nausea, vomiting. Interferon β-1a may cause flu-like symptoms, injection site reactions, liver problems and blood cell count changes.

CONNECT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body weight is at least 30 kg.
Select...
I have been diagnosed with relapsing-remitting MS.
Select...
I can walk without help, with a disability score up to 5.5.

CONNECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants That Experience Adverse Events (AEs) or Serious Adverse Events (SAEs)
Number of Participants Who Discontinue Study Treatment due to an AE
Secondary outcome measures
Annualized Relapse Rate
Change from Baseline in Bone Age
Change from Baseline in Brief Visuospatial Memory Test - Revised (BVMT-R) Score
+19 more

Side effects data

From 2015 Phase 4 trial • 241 Patients • NCT02090413
56%
Flushing
29%
Nausea
24%
Diarrhoea
23%
Headache
20%
Nasopharyngitis
18%
Vomiting
13%
Abdominal pain
13%
Urinary tract infection
9%
Pain in extremity
9%
Lower respiratory tract infection
9%
Fatigue
9%
Abdominal pain upper
8%
Fall
8%
Oropharyngeal pain
6%
Constipation
6%
Abdominal distension
6%
Sinusitis
6%
Paraesthesia
6%
Cough
6%
Lymphocyte count decreased
6%
Multiple sclerosis relapse
5%
Gastrooesophageal reflux disease
5%
Dizziness
5%
Dyspepsia
5%
Upper respiratory tract infection
5%
Hypoaesthesia
5%
Pruritus
5%
Rash
5%
Influenza like illness
4%
Musculoskeletal pain
4%
Arthralgia
4%
Optic neuritis
4%
Balance disorder
4%
Rhinorrhea
4%
Alanine aminotransferase increased
4%
Back pain
4%
Gait disturbance
4%
Viral infection
4%
Muscle spasms
3%
Depressed mood
3%
Tonsillitis
3%
Abdominal pain lower
3%
Toothache
3%
Chills
3%
Abdominal discomfort
3%
Candida infection
3%
Gastroenteritis
3%
Influenza
3%
Gastric infection
3%
Muscular weakness
3%
Alopecia
3%
Rash generalised
3%
Dyspnoea
3%
Chest discomfort
3%
Vaginal haemorrhage
3%
Vision blurred
3%
Anxiety
3%
Asthenia
1%
Hypophosphataemia
1%
Memory impairment
1%
Irritability
1%
Chest pain
1%
Gingival bleeding
1%
Haematemesis
1%
Pain in jaw
1%
Conjunctival haemorrhage
1%
Dysarthria
1%
Patella fracture
1%
Device failure
1%
Pruritis generalised
1%
Head injury
1%
Tinnitus
1%
Oral candidiasis
1%
Musculoskeletal discomfort
1%
Amnesia
1%
Gout
1%
Costochondritis
1%
Pneumonia
1%
Drug intolerance
1%
Eructation
1%
Flatulence
1%
Gastroenteritis viral
1%
Herpes zoster
1%
Infected dermal cyst
1%
Migraine
1%
Syncope
1%
Tremor
1%
Limb discomfort
1%
Myalgia
1%
Urticaria
1%
Pain
1%
Feeling abnormal
1%
Menorrhagia
1%
Breast mass
1%
Epicondylitis
1%
Liver function test abnormal
1%
Smear cervix abnormal
1%
Hypertension
1%
Hypersensitivity
1%
Gastroenteritis norovirus
1%
Herpes simplex
1%
Labyrinthitis
1%
Lyme disease
1%
Pyuria
1%
Lethargy
1%
Nerve compression
1%
Weight decreased
1%
Haemoglobin decreased
1%
Muscle strain
1%
Limb injury
1%
Wrist fracture
1%
Eye pain
1%
Vertigo
1%
Metrorrhagia
1%
Testicular cyst
1%
Lymphopenia
1%
Biliary colic
1%
Bowen's disease
1%
Contusion
1%
Skin infection
1%
Blood alkaline phosphatase increased
1%
Ear pain
1%
Gastrointestinal disorder
1%
Accidental overdose
1%
Mastication disorder
1%
Psoriasis
1%
Type 2 diabetes mellitus
1%
Bronchitis
1%
Viral upper respiratory tract infection
1%
Food allergy
1%
Seasonal allergy
1%
Micturition urgency
100%
80%
60%
40%
20%
0%
Study treatment Arm
DMF + ASA-Placebo BID
DMF + ASA 150 mg BID
DMF + ASA 75 mg QAM

CONNECT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BG00012Experimental Treatment1 Intervention
Participants will receive the recommended dose of 240 mg orally, twice a day
Group II: IFN β-1a (Avonex)Active Control1 Intervention
Participants will receive the recommended dose of 30 μg (weekly)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dimethyl fumarate
2016
Completed Phase 4
~11110

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
638 Previous Clinical Trials
467,270 Total Patients Enrolled
226 Trials studying Multiple Sclerosis
142,176 Patients Enrolled for Multiple Sclerosis
Medical DirectorStudy DirectorBiogen
2,766 Previous Clinical Trials
8,060,637 Total Patients Enrolled
136 Trials studying Multiple Sclerosis
126,243 Patients Enrolled for Multiple Sclerosis

Media Library

BG00012 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT02283853 — Phase 3
Multiple Sclerosis Research Study Groups: IFN β-1a (Avonex), BG00012
Multiple Sclerosis Clinical Trial 2023: BG00012 Highlights & Side Effects. Trial Name: NCT02283853 — Phase 3
BG00012 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02283853 — Phase 3

Frequently Asked Questions

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

What are the common applications for dimethyl fumarate?

"Multiple sclerosis, parenteral drug administration, and other conditions can benefit from therapy using dimethyl fumarate."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~20 spots leftby Sep 2025