TOLERATE - A Study that evaluates the Gastrointestinal Tolerability of DMF in Multiple Sclerosis Patients

• Register: EUCTR
• Last refreshed on: 25 April 2016
• Main ID: EUCTR2013-001486-17-DE
• Date of registration: 05/03/2014
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Research Limited
• Public title: TOLERATE - A Study that evaluates the Gastrointestinal Tolerability of DMF in Multiple Sclerosis Patients
• Scientific title: A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects with Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE)
• Date of first enrolment: 06/05/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001486-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Germany

Contacts

• Name: Clinical Trials - Neurology
• Affiliation: Biogen Idec Research Limited

• Name: Clinical Trials - Neurology
• Affiliation: Biogen Idec Research Limited

Key inclusion & exclusion criteria

Inclusion criteria:
Ability to understand the purpose and risks of the study and provide signed and dated informed consent in accordance with national and local patient privacy regulations.

Have a confirmed diagnosis of RRMS according to the current McDonald Criteria and satisfy the therapeutic indication as described in the official local registration for Tecfidera (see Fachinformation).

Age =18 years at the time of informed consent.

Naïve to DMF and fumaric acid esters.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
Inability to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation.

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

History of significant GI disease (e.g., irritable bowel disease, peptic ulcer disease, history of major GI surgeries), or chronic use of GI-related symptomatic therapy as determined by the Investigator (or =7 consecutive days of GI-related symptomatic therapy, e.g., loperamide hydrochloride, omeprazole, esomeprazole, lansoprazole, pantoprazole, paracetamol, acetylsalicylic acid, ranitidine, loratadine, butylscopolamine bromide, metoclopramide, domperidone, or dimethicone within the month prior to enrollment in the study).

Presence of one or more major comorbidities that, in the opinion of the Investigator, may affect the outcome of the study.

Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).

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

Current enrollment in any clinical trial or Biogen Idec sponsored study except the DMF Pregnancy Exposure Registry or other studies that, according to the study Medical Director, do not conflict with this study (e.g., health economics studies or local
registries).

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 Fachinformation precautions for use.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 18.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-

Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Primary end point(s): The frequency, severity, and duration of GI-related events in subjects who utilize symptomatic therapy during the 12-week Treatment Period, as measured by the Modified Overall Gastrointestinal Symptom Scale (MOGISS) and Modified Acute Gastrointestinal Symptom Scale (MAGISS).

Timepoint(s) of evaluation of this end point: 12-weeks

Secondary Objective: To evaluate GI-related events requiring symptomatic therapy and the role of those therapies over time

To evaluate GI-related events that lead to a physician’s decision to manage the events with DMF dose modification

To evaluate GI-related events that lead to DMF discontinuation after the use of symptomatic therapy

Main Objective: The primary objective of this study is to evaluate the effect of symptomatic therapies on GI-related events reported by subjects with RRMS initiating therapy with DMF in the clinical practice setting.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 12-weeks

Secondary end point(s): The cumulative proportion of subjects who require GI symptomatic therapy

The subject-reported type, frequency, and duration of symptomatic therapies used

The cumulative proportion of subjects who require DMF dose reduction in response to GI-related events

The percentage of subjects who discontinue DMF due to GI-related events

Secondary ID(s)

NCT02125604

109MS407

Source(s) of Monetary Support

Biogen Idec Research Limited