Effect of MD1003 in Spinal Progressive Multiple Sclerosis (MS-SPI)

March 23, 2017 updated by: MedDay Pharmaceuticals SA

Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France, 33000
        • Hôpital Pellegrin
      • Caen, France, 14000
        • Hôpital de la Côte de Nacre
      • Clermont Ferrand, France, 63000
        • Hôpital Gabriel Montpied
      • Dijon, France, 21000
        • Hopital general du Bocage
      • Lyon, France, 69000
        • Hopital Pierre Wertheimer
      • Marseille, France, 13000
        • Hôpital de la Timone
      • Montpellier, France, 34000
        • Hopital Gui de Chauliac
      • Nancy, France, 54000
        • Hôpital Central
      • Nantes, France, 44000
        • Hôpital Nord Laennec
      • Nice, France, 06000
        • Hopital PASTEUR
      • Paris, France, 75019
        • Fondation Rothschild
      • Paris, France, 75013
        • Groupe Hospitalier La Pitie-Salpetriere
      • Poissy, France, 78300
        • Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
      • Reims, France, 51000
        • Hôpital Maison Blanche
      • Rennes, France, 35000
        • Hôpital Pontchaillou
      • Strasbourg, France, 67000
        • Hôpital Hautepierre
      • Toulouse, France, 31000
        • Hopital Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MD1003
MD1003 100mg capsules, 1 capsule tid for 24 months
Placebo Comparator: Placebo
Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25)
Time Frame: up to 24 months

Proportions of patients in each treatment arm:

- with decreased EDSS at M9 confirmed at Month12 (where decreased EDSS is defined as a decrease of at least 0.5 point if initial EDSS from 6 to 7 and a decrease of at least 1 point if initial EDSS from 4.5 to 5.5)

or

- with improved TW25 of at least 20% at Month 9 and Month12

compared to the best EDSS and TW25 scores among screening visit (Month-1) and randomization visit (baseline)

up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple Sclerosis Walking Scale (MSWS)
Time Frame: Baseline, 12 months, 24 months
The 12-item multiple sclerosis walking scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability.
Baseline, 12 months, 24 months
Clinical Global Impression / Subject Global Impression (CGI / SGI)
Time Frame: 12 months, 24 months

The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

The clinical global impression will be assessed by the patient (subject global impression, SGI) and by the clinician (clinician global impression, CGI).

12 months, 24 months
Unidimensional Fatigue Impact Scale (U-FIS)
Time Frame: Baseline, 12 months, 24 months
The U-FIS has 22-items measuring the impact of fatigue.
Baseline, 12 months, 24 months
Multiple Sclerosis Quality of Life Scale (SEP-59)
Time Frame: Baseline, 12 months, 24 months
The SEP-59 is a multidimensional health-related quality of life measure that combines 36 generic items and 29 MS-specific items into a single instrument.
Baseline, 12 months, 24 months
Hole Peg Test (9-HPT)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
The 9-HPT apparatus comprises a container with nine pegs and an empty pegboard with nine holes, set three by three. The pegs must be picked up one at a time and placed in the holes as quickly as possible until all holes are filled. Then, without pausing, the pegs should be removed one at a time, again as quickly as possible. This should be performed twice for each hand. If a peg falls onto the table, the peg should be picked up with the hand which is being tested. If a peg falls onto the floor, it is picked up by the examiner. The time is recorded in seconds, starting as the patient picks up the first peg and ending when the last peg drops into the container.
Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain MRI
Time Frame: Baseline, 12 months
Brain MRI using at least T2 and T1 sequences with gadolinium injection will be performed in a subset of 72 patients i.e 24 in the placebo group and 48 in the treated group, at study onset and after 12 months. Safety of MD1003 will be assessed by comparing novel T2 hypersignals as well as T1 post-gadolinium enhancing lesions in the two groups.
Baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ayman Tourbah, MD, PhD, Hôpital Maison Blanche, Reims, France
  • Study Director: Frederic Sedel, MD, PhD, Medday SAS, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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