Tecfidera Slow-Titration Study (TITRATION)

Biogen

Status and phase: Terminated; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: dimethyl fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02428231

2014-004562-22 (EudraCT Number)

109MS416

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Standard Treatment (One-Week Titration)

Active Comparator group

Description:

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

Treatment:

Drug: dimethyl fumarate

Slow Up-Titration (Six-Week Titration)

Experimental group

Description:

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

Treatment:

Drug: dimethyl fumarate