Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012

Biogen221 enrolled

Overview

The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue, quality of life, and work and social life activity.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

221

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

dimethyl fumarateDRUG

dimethyl fumarate administered as per the arm description

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005). * Must have a baseline EDSS between 0.0 and 5.0, inclusive. * Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of gadolinium-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization. Key Exclusion Criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening: * Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996) * Severe depression (MADRS score \>34) (Montgomery and Asberg 1979) * History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment) * An MS relapse that has occurred within the 30 days prior to inclusion AND/OR the participant has not stabilized from a previous relapse prior to inclusion.

Locations (18)

Research site

Bari, Italy

Research site

Cagliari, Italy

Research site

Catania, Italy

Outcomes

Primary Outcomes

Proportion of patients with worsening in cognitive improvement over 2 years.

As measured by at least 2 standard deviation (SD) below Italian normative data of the Rao's Brief Repeatable Battery of Neuropsychological Tests (BRB) and a 100-item version of the Stroop Test. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) is a sensitive measure of cognitive impairment in multiple sclerosis (MS) patients. The Stroop Test is a test used to measure a person's sustained attention for word reading and color naming with and without interference.

Time frame: Up to 2 years

Secondary Outcomes

Change in cognitive impairment index score (CII) over two years

An individual cognitive change index will be measured by calculating changes on the cognitive impairment index (CII) for each participant between year 0 and year 1, and year 0 and year 2. The CII is an individual cognitive change index aimed at providing a more precise assessment of the amount and direction of cognitive changes over time.

Time frame: Up to 2 years

Annualized relapse rate at year 1.

Time frame: Up to one year

Annualized relapse rate at year 2.

Time frame: Up to 2 years

Time to relapse over 2 years.

Time frame: 2 years

Proportion of patients with 6-month sustained progression of disability as measured by at least a 1.0 point increase from a baseline EDSS>1.0 or at least a 1.5 point increase from a baseline EDSS=0).

The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. Each functional system is scored on a scale of 0 (no disability) to 5 or 6 (more severe disability). EDSS steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.

Data from ClinicalTrials.gov

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