Gastrointestinal Tolerability Study Of Dimethyl Fumarate (DMF) In Participants With Relapsing-Remitting Multiple Sclerosis In Germany

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— TOLERATE  

Official title:

A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects With Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125604
• Other study ID #: 109MS407
• Secondary ID: 2013-001486-17
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2014
• Last updated: April 9, 2016
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal-related events reported by participants with relapsing-remitting multiple sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice setting.

The secondary objectives of this study in this study population are as follows: To evaluate gastrointestinal-related events requiring symptomatic therapy and the role of those therapies over time; To evaluate gastrointestinal-related events that lead to a physician's decision to manage the events with BG00012 dose modification; and To evaluate gastrointestinal-related events that lead to BG00012 discontinuation after the use of symptomatic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Have a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the current McDonald Criteria and satisfy the therapeutic indication as described in the official local registration for Tecfidera (dimethyl fumarate).

• Naïve to dimethyl fumarate (DMF) and fumaric acid esters.

Key Exclusion Criteria:

• Female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study

• History of significant gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries), or chronic use of gastrointestinal -related symptomatic therapy as determined by the Investigator (or =7 consecutive days of gastrointestinal -related symptomatic therapy

• Known active malignancies

• History of anaphylaxis or severe allergic reactions or known drug hypersensitivity

• Current use of B vitamin supplements

• In the opinion of the Investigator, blood test values suggestive of a low lymphocyte count or renal or hepatic impairment, as described in the product label precautions for use.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
BG00012 capsules administered according to the prevailing product label.

Locations

Country	Name	City	State
Germany	Research Site	Augsburg
Germany	Research Site	Bamburg
Germany	Research Site	Bayreuth
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Bonn
Germany	Research Site	Erbach
Germany	Research Site	Erlangen
Germany	Research Site	Freiburg
Germany	Research Site	Hamburg
Germany	Research Site	Leipzig
Germany	Research Site	Marburg
Germany	Research Site	Minden
Germany	Research Site	Mittweida
Germany	Research Site	Munchen
Germany	Research Site	Munster
Germany	Research Site	Osnabruck
Germany	Research Site	Potsdam
Germany	Research Site	Siegen

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Of Gastrointestinal-Related Events In Participants Who Utilize Symptomatic Therapy During The 12-Week Treatment Period	Gastrointestinal-related events as measured by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) and Modified Acute Gastrointestinal Symptom Scale (MAGISS)	Up to Week 12	Yes
Primary	Severity Of Gastrointestinal -Related Events In Participants Who Utilize Symptomatic Therapy During The 12-Week Treatment Period		Up to Week 12	Yes
Primary	Duration Of Gastrointestinal -Related Events In Participants Who Utilize Symptomatic Therapy During The 12-Week Treatment Period		Up to Week 12	Yes
Secondary	Percentage Of Participants Requiring Gastrointestinal Symptomatic Therapy During The 12-Week Treatment Period		Up to Week 12	Yes
Secondary	Number of Participants Who Used Symptomatic Therapies for Gastrointestinal -Related Events During the 12-Week Treatment Period		Up to Week 12	Yes
Secondary	Duration of Use of Symptomatic Therapies for Gastrointestinal -Related Events During the 12-Week Treatment Period		Up to Week 12	Yes
Secondary	Kaplan-Meier Estimates for the Proportion of Participants Who Require BG00012 Dose Reduction In Response To Gastrointestinal -Related Events		Up to Week 12	Yes
Secondary	The Percentage of Participants Who Discontinue BG00012 Due To Gastrointestinal -Related Events		Up to Week 12	Yes