Phase 4 GI Tolerability Study of DMF in Patients With Relapsing Forms of MS in the US
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/-0001 |
| Start Date: | May 2013 |
| End Date: | September 2014 |
| Contact: | Biogen Idec |
| Email: | neurologyclinicaltrials@biogenidec.com |
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
The primary objective of this study is to evaluate the effect of symptomatic therapies on
Gastrointestinal (GI) related events reported by patients 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 Gastrointestinal (GI) related events requiring symptomatic therapy and the
role of those therapies over time in patients with relapsing forms of Multiple
Sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical practice
setting.
- To evaluate Gastrointestinal (GI) related events that lead to dimethyl fumarate (DMF)
discontinuation after the use of symptomatic therapy in patients with relapsing forms
of Multiple Sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the
clinical practice setting.
Inclusion Criteria:
- Decision to treat with Dimethyl fumarate (DMF) must precede enrollment.
- Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (PHI).
- Age greater than or equal to 18 years at the time of informed consent.
- Naïve to Dimethyl fumarate (DMF) or fumaric acid esters.
- Resides in the US and has a confirmed diagnosis of a relapsing form of Multiple
Sclerosis (MS).
- Satisfies the approved therapeutic indication(s) for Dimethyl fumarate (DMF).
Exclusion Criteria:
- Inability to comply with study requirements or, at the discretion of the
Investigator, is deemed unsuitable for study participation.
- History of significant Gastrointestinal (GI) disease, chronic use of Gastrointestinal
(GI) symptomatic therapy, active malignancies.
- Is participating in any interventional clinical trial.
We found this trial at
21
sites
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