Clinical trial NCT02428231: Tecfidera Slow-Titration Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Proportion of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: from Week 2 (Baseline) to Week 14
Secondary outcomes:
measure: Average Change From Baseline in GSRS Scores During DMF Treatment
timeFrame: Week 2 (Baseline), Week 14
measure: Time to First Worsening From Baseline in GSRS Score
timeFrame: Week 2 (Baseline), Week 14
measure: Time to Recovery to Baseline From Last Occurrence of Worst GSRS Score
timeFrame: Week 2 (Baseline), Week 14
measure: Average Change From Baseline in GSRS Scores to the End of Weeks 4, 6, 8, 10, 12, and 14
timeFrame: Week 2 (Baseline), Weeks 4, 6, 8, 10, 12, 14
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Long Beach
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: Avon
country: United States
facility: Research Site
state: Indiana
city: Franklin
country: United States
facility: Research Site
state: Indiana
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Lewiston
country: United States
facility: Research Site
state: Maine
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Cary
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Wenatchee
country: United States
facility: Research Site
state: Washington
city: Leuven
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Prague
country: Czech Republic
facility: Research Site
city: Merano
country: Italy
facility: Research Site
state: Bolzano
city: Montichiari
country: Italy
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: