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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02579681
• Date of registration: 16/10/2015
• Prospective Registration: No
• Primary sponsor: Biogen
• Public title: Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012 StarTec
• Scientific title: Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012
• Date of first enrolment: April 30, 2014
• Target sample size: 221
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02579681
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Italy

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: dimethyl fumarate

Primary Outcome(s)

Proportion of patients with worsening in cognitive improvement over 2 years. [Time Frame: Up to 2 years]

Secondary Outcome(s)

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). [Time Frame: Up to 2 years]

Annualized relapse rate at year 2. [Time Frame: Up to 2 years]

Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years. [Time Frame: Up to 2 years]

Annualized relapse rate at year 1. [Time Frame: Up to one year]

Change in cognitive impairment index score (CII) over two years [Time Frame: Up to 2 years]

Change from baseline in a self rating version of the Montgomery and Asberg Depression Rating Scale (MADRS) [Time Frame: 2 years]

Change from baseline in fatigue as measured by the Modified Fatigue Impact Scale (MFIS) [Time Frame: 2 years]

Change from baseline in Quality of life (QOL) as measured by the EQ-5D Health Survey [Time Frame: 2 years]

Change from baseline in the Environmental Status Scale (ESS) [Time Frame: 2 years]

Time to relapse over 2 years. [Time Frame: 2 years]

Secondary ID(s)

2013-001422-25

109MS410

ITA-BGT-12-10389

Source(s) of Monetary Support

Please refer to primary and secondary sponsors