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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
MD1003 100mg capsule
Placebo
Sponsored by
MedDay Pharmaceuticals SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, MS, EDSS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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."

Sites / Locations

  • Hopital Pellegrin
  • Hopital de la cote de Nacre
  • Hopital Gabriel Montpied
  • Hopital general du Bocage
  • Hopital Pierre Wertheimer
  • Hopital de la Timone
  • Hopital Gui de Chauliac
  • Hopital Central
  • Hopital Nord Laennec
  • Hopital Pasteur
  • Groupe hospitalier la Pitié-Salpêtrière
  • Fondation Rothschild
  • Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
  • Hopital Maison Blanche
  • Hopital Pontchaillou
  • Hopital Hautepierre
  • Hopital Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MD1003

Placebo

Arm Description

MD1003 100mg capsules, 1 capsule tid for 24 months

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Multiple Sclerosis Walking Scale (MSWS)
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.
Clinical Global Impression / Subject Global Impression (CGI / SGI)
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).
Unidimensional Fatigue Impact Scale (U-FIS)
The U-FIS has 22-items measuring the impact of fatigue.
Multiple Sclerosis Quality of Life Scale (SEP-59)
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.
Hole Peg Test (9-HPT)
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.

Full Information

First Posted
August 18, 2014
Last Updated
March 23, 2017
Sponsor
MedDay Pharmaceuticals SA
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1. Study Identification

Unique Protocol Identification Number
NCT02220933
Brief Title
Effect of MD1003 in Spinal Progressive Multiple Sclerosis
Acronym
MS-SPI
Official Title
Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedDay Pharmaceuticals SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, MS, EDSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MD1003
Arm Type
Experimental
Arm Description
MD1003 100mg capsules, 1 capsule tid for 24 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months
Intervention Type
Drug
Intervention Name(s)
MD1003 100mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25)
Description
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)
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Multiple Sclerosis Walking Scale (MSWS)
Description
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.
Time Frame
Baseline, 12 months, 24 months
Title
Clinical Global Impression / Subject Global Impression (CGI / SGI)
Description
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).
Time Frame
12 months, 24 months
Title
Unidimensional Fatigue Impact Scale (U-FIS)
Description
The U-FIS has 22-items measuring the impact of fatigue.
Time Frame
Baseline, 12 months, 24 months
Title
Multiple Sclerosis Quality of Life Scale (SEP-59)
Description
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.
Time Frame
Baseline, 12 months, 24 months
Title
Hole Peg Test (9-HPT)
Description
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.
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Other Pre-specified Outcome Measures:
Title
Brain MRI
Description
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.
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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."
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Tourbah, MD, PhD
Organizational Affiliation
Hopital Maison Blanche, Reims, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederic Sedel, MD, PhD
Organizational Affiliation
Medday SAS, Paris, France
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hopital de la cote de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Hopital Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hopital general du Bocage
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Pierre Wertheimer
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Hopital de la Timone
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Hopital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Hopital Central
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Hopital Nord Laennec
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hopital Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Groupe hospitalier la Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Fondation Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
Hopital Maison Blanche
City
Reims
ZIP/Postal Code
51000
Country
France
Facility Name
Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Hopital Hautepierre
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hopital Purpan
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.medday-pharma.com
Description
Related Info

Learn more about this trial

Effect of MD1003 in Spinal Progressive Multiple Sclerosis

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