MSFrontier

MS-SPI

Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study
Status unknownPhase 3Progressive MSNCT022209332013-002113-35

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“A total of 13 (12.6%) MD1003-treated patients achieved the primary endpoint versus none of the placebo-treated patients (p = 0.005).”
Read by software from the paper's abstract

proportion of patients with disability reversal at month 9, confirmed at month 12, defined as an EDSS decrease of ⩾1 point (⩾0.5 for EDSS 6-7) or a ⩾20% decrease in timed 25-foot walk time · month 9, confirmed at month 12

GroupnValue
MD100313 (12.6%)

p = 0.005

Total participants: 154

Read by software from the paper's abstract

What was tested

Treatment tested

  • MD1003 100mg capsule
  • Biotin

Placebo or sham

  • Placebo

What it measured

Main measures

  • Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25)

    up to 24 months

    Disability progressionWalking and mobility

  • Proportion of patients with decreased EDSS at M12 (defined as a decrease of at least 0.5 point if initial EDSS between 6 and 7 and a decrease of at least 1 point if initial EDSS between 4.5 and 5.5)

    Disability progression

Other measures (6)

  • Multiple Sclerosis Walking Scale (MSWS)

    Baseline, 12 months, 24 months

    Walking and mobility

  • Clinical Global Impression / Subject Global Impression (CGI / SGI)

    12 months, 24 months

  • Unidimensional Fatigue Impact Scale (U-FIS)

    Baseline, 12 months, 24 months

    Fatigue

  • Multiple Sclerosis Quality of Life Scale (SEP-59)

    Baseline, 12 months, 24 months

    Quality of life (reported by participants)

  • Hole Peg Test (9-HPT)

    Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

    Walking and mobility

  • - Proportion of patients with increased EDSS score of at least 0.5 at M12 (or M24 during the extension phase)

    Disability progression

Who could take part

Progressive MS · 18 to 75

Inclusion Criteria: * Diagnosis criteria of secondary or primary progressive MS with clinical evidence of spastic paraparesis fulfilling revised McDonald criteria (2010) and Lublin criteria (1996) * Progression of the EDSS during the past two years of at least 1 point if EDSS from 4.5 to 5.5 and at least 0.5 point if EDSS from 6 to 7 * EDSS score from 4.5 to 7 (measured away from a relapse and confirmed at 6 months) * Informed consent prior to any study procedure * Patient aged 18-75 years Exclusion Criteria: * Any general chronic handicapping disease other than MS * Intensive physical therapy program within the 3 months prior to inclusion * Impossibility to perform the TW25 test * New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine * Pregnancy or woman with childbearing potential without contraception * Evidence of inflammatory activity of the disease defined as "clinical evidence of a relapse during the year before inclusion or evidence of new gadolinium-enhanced lesions on a brain MRI performed the year before inclusion."

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

About this trial

In the sponsor's words

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.

Papers

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Related trials

History

    1. Started

      Oct 2013

    2. Main results due

      Jan 2016

    3. Finished

      Jan 2018

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