Tecfidera Slow-Titration Study

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard Treatment (One-Week Titration)

120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks

Group Type ACTIVE_COMPARATOR

dimethyl fumarate

Intervention Type DRUG

Participants will be dosed twice daily for 12 weeks.

Slow Up-Titration (Six-Week Titration)

120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF twice daily for 6 weeks

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

Participants will be dosed twice daily for 12 weeks.

Interventions

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dimethyl fumarate

Participants will be dosed twice daily for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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DMF Tecfidera BG00012

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No