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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02220933 |
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Date of registration:
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18/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of MD1003 in Spinal Progressive Multiple Sclerosis
MS-SPI |
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Scientific title:
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Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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144 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02220933 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Frederic Sedel, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medday SAS, Paris, France |
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Name:
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Ayman Tourbah, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Maison Blanche, Reims, France |
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Key inclusion & exclusion criteria
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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."
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: MD1003 100mg capsule
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Drug: Placebo
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Primary Outcome(s)
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Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25)
[Time Frame: up to 24 months]
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Secondary Outcome(s)
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Unidimensional Fatigue Impact Scale (U-FIS)
[Time Frame: Baseline, 12 months, 24 months]
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Clinical Global Impression / Subject Global Impression (CGI / SGI)
[Time Frame: 12 months, 24 months]
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Multiple Sclerosis Walking Scale (MSWS)
[Time Frame: Baseline, 12 months, 24 months]
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Hole Peg Test (9-HPT)
[Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months]
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Multiple Sclerosis Quality of Life Scale (SEP-59)
[Time Frame: Baseline, 12 months, 24 months]
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Secondary ID(s)
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2013-002113-35
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MD1003CT2013-02MS-SPI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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