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

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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

Tracking Information
First Submitted Date  ICMJE August 18, 2014
First Posted Date  ICMJE August 20, 2014
Last Update Posted Date March 27, 2017
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02220933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
  • 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.
  • 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).
  • Unidimensional Fatigue Impact Scale (U-FIS) [ Time Frame: Baseline, 12 months, 24 months ]
    The U-FIS has 22-items measuring the impact of fatigue.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 19, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of MD1003 in Spinal Progressive Multiple Sclerosis
Official Title  ICMJE Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: MD1003 100mg capsule
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: MD1003
    MD1003 100mg capsules, 1 capsule tid for 24 months
    Intervention: 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
    Interventions:
    • Drug: MD1003 100mg capsule
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 19, 2014)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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."
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02220933
Other Study ID Numbers  ICMJE MD1003CT2013-02MS-SPI
2013-002113-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedDay Pharmaceuticals SA
Study Sponsor  ICMJE MedDay Pharmaceuticals SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ayman Tourbah, MD, PhD Hopital Maison Blanche, Reims, France
Study Director: Frederic Sedel, MD, PhD Medday SAS, Paris, France
PRS Account MedDay Pharmaceuticals SA
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP