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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220933
Recruitment Status : Unknown
Verified March 2017 by MedDay Pharmaceuticals SA.
Recruitment status was:  Active, not recruiting
First Posted : August 20, 2014
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: MD1003 100mg capsule Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study
Actual Study Start Date : October 2013
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MD1003
MD1003 100mg capsules, 1 capsule tid for 24 months
 Drug: MD1003 100mg capsule
Placebo Comparator: Placebo
Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months
 Drug: MD1003 100mg capsule
Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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.

  2. 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).


  3. Unidimensional Fatigue Impact Scale (U-FIS) [ Time Frame: Baseline, 12 months, 24 months ]
    The U-FIS has 22-items measuring the impact of fatigue.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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."
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220933


Locations
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Sponsors and Collaborators
MedDay Pharmaceuticals SA
Investigators
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Principal Investigator: Ayman Tourbah, MD, PhD Hopital Maison Blanche, Reims, France
Study Director: Frederic Sedel, MD, PhD Medday SAS, Paris, France
More Information
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Additional Information:

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Responsible Party: MedDay Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02220933    
Other Study ID Numbers: MD1003CT2013-02MS-SPI
2013-002113-35 ( EudraCT Number )
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Keywords provided by MedDay Pharmaceuticals SA:
Multiple Sclerosis
MS
EDSS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes