Tecfidera Slow-Titration Study
A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Sponsor decision
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Standard 1-Week Titration Arm | 30 | 2 (6.7%) | |
| 6-Week Titration Arm | 32 | 1 (3.1%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Proportion of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the Gastrointestinal Symptom Rating Scale (GSRS)
from Week 2 (Baseline) to Week 14
SafetyThe primary endpoint is the proportion of subjects with a worsening in severity of GI AEs, defined as a positive average change from baseline to the end of BG00012 treatment in the Gastrointestinal Symptom Rating Scale (GSRS).
Other measures (5)
Average Change From Baseline in GSRS Scores During DMF Treatment
Week 2 (Baseline), Week 14
Time to First Worsening From Baseline in GSRS Score
Week 2 (Baseline), Week 14
Time to Recovery to Baseline From Last Occurrence of Worst GSRS Score
Week 2 (Baseline), Week 14
Average Change From Baseline in GSRS Scores to the End of Weeks 4, 6, 8, 10, 12, and 14
Week 2 (Baseline), Weeks 4, 6, 8, 10, 12, 14
The secondary endpoints are as follows:
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of MS consistent with locally labeled indication for DMF * No prior treatment with DMF * Female subjects of childbearing potential who are not surgically sterile and male subjects must practice effective contraception during their participation in the study * Have had a recent complete blood count (CBC), including lymphocyte count, that does not preclude participation in the study, in the judgement of the investigator Key Exclusion Criteria: * Have a recent history or ongoing GI illness (e.g., peptic ulcer, irritable bowel syndrome) or any other current condition with GI signs and symptoms (e.g., nausea, vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study endpoints * Have other major comorbid conditions that preclude participation in the study, as determined by the investigator * Participant is pregnant, breastfeeding, or planning a pregnancy during the study period * Are receiving concomitant disease-modifying therapies for MS including, but not limited to, natalizumab, interferon beta, glatiramer acetate, fingolimod, alemtuzumab, teriflunomide, or laquinimod at screening * History of severe allergic or anaphylactic reactions or known drug hypersensitivity * NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF [Tecfidera])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of DMF treatment in this study population.
Papers
Loading reviews and guidelines…
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History
Started
Apr 2015
Main results due
Dec 2015
Finished
Jan 2016
Results posted
May 2017