Clinical trial NCT02579681: Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012
Official title: Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Cognition
Tecfidera
RRMS
BG00012
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients with worsening in cognitive improvement over 2 years.
timeFrame: Up to 2 years
Secondary outcomes:
measure: Change in cognitive impairment index score (CII) over two years
timeFrame: Up to 2 years
measure: Annualized relapse rate at year 1.
timeFrame: Up to one year
measure: Annualized relapse rate at year 2.
timeFrame: Up to 2 years
measure: Time to relapse over 2 years.
timeFrame: 2 years
measure: 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).
timeFrame: Up to 2 years
measure: Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.
timeFrame: Up to 2 years
measure: Change from baseline in a self rating version of the Montgomery and Asberg Depression Rating Scale (MADRS)
timeFrame: 2 years
measure: Change from baseline in fatigue as measured by the Modified Fatigue Impact Scale (MFIS)
timeFrame: 2 years
measure: Change from baseline in Quality of life (QOL) as measured by the EQ-5D Health Survey
timeFrame: 2 years
measure: Change from baseline in the Environmental Status Scale (ESS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Research site
city: Cagliari
country: Italy
facility: Research site
city: Catania
country: Italy
facility: Research site
city: Cefalu
country: Italy
facility: Research site
city: Chieti
country: Italy
facility: Research site
city: Ferrara
country: Italy
facility: Research site
city: Fidenza
country: Italy
facility: Research site
city: Firenze
country: Italy
facility: Research site
city: Gallarate
country: Italy
facility: Research site
city: Genova
country: Italy
facility: Research site
city: L'aquila
country: Italy
facility: Research site
city: Milano
country: Italy
facility: Research site
city: Napoli
country: Italy
facility: Research site
city: Orbassano
country: Italy
facility: Research site
city: Padova
country: Italy
facility: Research site
city: Palermo
country: Italy
facility: Research site
city: Pavia
country: Italy
facility: Research site
city: Roma
country: Italy
facility: Research site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: