NCT02220933

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P25-P50 for phase_3 multiple-sclerosis

Timeline
Completed

Started Oct 2013

Typical duration for phase_3 multiple-sclerosis

Geographic Reach
1 country

17 active sites

Status
unknown

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

October 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

August 18, 2014

Last Update Submit

March 23, 2017

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisMSEDSS

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (5)

  • Multiple Sclerosis Walking Scale (MSWS)

    Baseline, 12 months, 24 months

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

    12 months, 24 months

  • Unidimensional Fatigue Impact Scale (U-FIS)

    Baseline, 12 months, 24 months

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

    Baseline, 12 months, 24 months

  • Hole Peg Test (9-HPT)

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

Other Outcomes (1)

  • Brain MRI

    Baseline, 12 months

Study Arms (2)

MD1003

EXPERIMENTAL

MD1003 100mg capsules, 1 capsule tid for 24 months

Drug: MD1003 100mg capsule

Placebo

PLACEBO COMPARATOR

Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months

Drug: MD1003 100mg capsuleDrug: Placebo

Interventions

MD1003 100mg capsuleDRUG
MD1003Placebo
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any general chronic handicapping disease other than MS
  • Impossibility to perform the TW25 test
  • Pregnancy or woman with childbearing potential without contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hopital Pellegrin

Bordeaux, 33000, France

Location

Hopital de la cote de Nacre

Caen, 14000, France

Location

Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Hopital general du Bocage

Dijon, 21000, France

Location

Hopital Pierre Wertheimer

Lyon, 69000, France

Location

Hopital de la Timone

Marseille, 13000, France

Location

Hopital Gui de Chauliac

Montpellier, 34000, France

Location

Hopital Central

Nancy, 54000, France

Location

Hopital Nord Laennec

Nantes, 44000, France

Location

Hopital Pasteur

Nice, 06000, France

Location

Groupe hospitalier la Pitié-Salpêtrière

Paris, 75013, France

Location

Fondation Rothschild

Paris, 75019, France

Location

Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye

Poissy, 78300, France

Location

Hopital Maison Blanche

Reims, 51000, France

Location

Hopital Pontchaillou

Rennes, 35000, France

Location

Hopital Hautepierre

Strasbourg, 67000, France

Location

Hopital Purpan

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ayman Tourbah, MD, PhD

    Hopital Maison Blanche, Reims, France

    PRINCIPAL INVESTIGATOR

  • Frederic Sedel, MD, PhD

    Medday SAS, Paris, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 20, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2018

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

FR(17)