NCT02579681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2014

Typical duration for phase_3

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

October 16, 2015

Last Update Submit

April 26, 2017

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

CognitionTecfideraRRMSBG00012

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 2 years

Secondary Outcomes (10)

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

    Up to 2 years

  • Annualized relapse rate at year 1.

    Up to one year

  • Annualized relapse rate at year 2.

    Up to 2 years

  • Time to relapse over 2 years.

    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).

    Up to 2 years

  • +5 more secondary outcomes

Study Arms (1)

BG00012

EXPERIMENTAL

BG00012 administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter.

Drug: dimethyl fumarate

Interventions

dimethyl fumarateDRUG

dimethyl fumarate administered as per the arm description

Also known as: Tecfidera, DMF, BG00012
BG00012

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Research site

Bari, Italy

Location

Research site

Cagliari, Italy

Location

Research site

Catania, Italy

Location

Research site

Cefalù, Italy

Location

Research site

Chieti, Italy

Location

Research site

Ferrara, Italy

Location

Research site

Fidenza, Italy

Location

Research site

Florence, Italy

Location

Research site

Gallarate, Italy

Location

Research site

Genova, Italy

Location

Research site

L’Aquila, Italy

Location

Research site

Milan, Italy

Location

Research site

Napoli, Italy

Location

Research site

Orbassano, Italy

Location

Research site

Padua, Italy

Location

Research site

Palermo, Italy

Location

Research site

Pavia, Italy

Location

Research site

Roma, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

April 30, 2014

Primary Completion

December 21, 2016

Study Completion

December 21, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

IT(18)