MSFrontier

StarTec

Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012
CompletedPhase 3Relapsing MSNCT025796812013-001422-25

What it found

No result found

We found no results in the registry or in papers.

This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

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

    Up to 2 years

    Thinking and memory

  • Proportion of patients with worsening in CI.

Other measures (10)

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

    Up to 2 years

    Thinking and memory

  • Annualized relapse rate at year 1.

    Up to one year

    Relapses

  • Annualized relapse rate at year 2.

    Up to 2 years

    Relapses

  • Time to relapse over 2 years.

    2 years

    Relapses

  • 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

    Disability progressionFatigue

  • Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.

    Up to 2 years

    FatigueMood and sleepQuality of life (reported by participants)

  • Change from baseline in a self rating version of the Montgomery and Asberg Depression Rating Scale (MADRS)

    2 years

    Mood and sleep

  • Change from baseline in fatigue as measured by the Modified Fatigue Impact Scale (MFIS)

    2 years

    Thinking and memoryFatigue

  • Change from baseline in Quality of life (QOL) as measured by the EQ-5D Health Survey

    2 years

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • Change from baseline in the Environmental Status Scale (ESS)

    2 years

Who could take part

Relapsing MS · 18 and over

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

Related trials

History

    1. Started

      Apr 2014

    2. Main results due

      Dec 2016

    3. Finished

      Dec 2016

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error