Phase 4
N=237
Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
Relapsing Forms of Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01873417 ↗Enrolled (actual)
237
Serious AEs
3.0%
Results posted
Nov 2014
Primary outcome: Primary: Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS) — 4.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- BG00012 (DMF) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS) |
4.8 | — |
| PRIMARY Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale |
4.7 | — |
| PRIMARY Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy |
54.1 | — |
| PRIMARY Duration of GI-related Episodes in DMF-treated Participants |
2.0; 1.6; 2.0; 1.8; 0.4; 1.9 | — |
| SECONDARY Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy |
54.1 | — |
| SECONDARY Participants' Use of Symptomatic Therapy, by Type and Category |
57; 50; 4; 1; 3; 2 | — |
| SECONDARY Summary of Use and Days on Symptomatic Therapy, by Category |
10.4; 5.9; 6.3; 9.0; 5.9; 3.9 | — |
| SECONDARY Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy |
13; 10; 6; 6; 5; 5 | — |
Summary
The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal (GI)-related events reported by participants with relapsing forms of multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical practice setting.
The secondary objectives of this study are as follows:
* To evaluate GI-related events requiring symptomatic therapy and the role of those therapies over time in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting.
* To evaluate GI-related events that lead to DMF discontinuation after the use of symptomatic therapy in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting.
Eligibility Criteria
Key Inclusion Criteria
- Decision to treat with DMF must precede enrollment.
- Naïve to DMF or fumaric acid esters.
- Resides in the US and has a confirmed diagnosis of a relapsing form of MS.
- Satisfies the approved therapeutic indication(s) for DMF.
Key Exclusion Criteria
- Inability to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation.
- History of significant GI disease, chronic use of GI symptomatic therapy, active malignancies.
- Is participating in any other interventional clinical trial.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01873417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.