Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Pa
A Multicenter, Open-Label, Single-Arm Study of Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera™ (Dimethyl Fumarate) Delayed-release Capsules
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
Results by group
Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS)
12 Weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 4.8 units on a scale | 2.34 (Standard Deviation) | 128 |
Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale
12 Weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 4.7 units on a scale | 2.13 (Standard Deviation) | 128 |
Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy
12 Weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 54.1 percentage of participants | 233 |
Duration of GI-related Episodes in DMF-treated Participants
12 Weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dimethyl Fumarate | 2.0 hours | 0–8.8 | 128 |
| Dimethyl Fumarate | 1.6 hours | 0–11 | 128 |
| Dimethyl Fumarate | 2.0 hours | 0–8 | 128 |
| Dimethyl Fumarate | 1.8 hours | 0.1–9.5 | 128 |
| Dimethyl Fumarate | 0.4 hours | 0–8 | 128 |
| Dimethyl Fumarate | 1.9 hours | 0–11 | 128 |
| Dimethyl Fumarate | 6.0 hours | 0–23 | 128 |
| Dimethyl Fumarate | 3.0 hours | 0–12.7 | 128 |
| Dimethyl Fumarate | 2.1 hours | 0.2–12.7 | 128 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Dimethyl Fumarate | 233 | 7 (3.0%) |
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
Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS)
12 Weeks
Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale
12 Weeks
Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy
12 Weeks
Duration of GI-related Episodes in DMF-treated Participants
12 Weeks
Bladder, bowel and sexual functionPain
Other measures (4)
Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy
12 Weeks
Participants' Use of Symptomatic Therapy, by Type and Category
12 Weeks
Summary of Use and Days on Symptomatic Therapy, by Category
12 Weeks
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
12 Weeks
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion 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.
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 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.
Papers
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History
Started
May 2013
Main results due
Nov 2013
Finished
Nov 2013
Results posted
Nov 2014