Effect of MD1003 in Spinal Progressive Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MS-SPI  

Official title:

Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02220933
• Other study ID #: MD1003CT2013-02MS-SPI
• Secondary ID: 2013-002113-35
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 18, 2014
• Last updated: March 23, 2017
• Start date: October 2013
• Est. completion date: January 2018

Study information

• Verified date: March 2017
• Source: MedDay Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: January 2018
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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."

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• MD1003 100mg capsule

• Placebo

Locations

Country	Name	City	State
France	Hopital Pellegrin	Bordeaux
France	Hopital de la cote de Nacre	Caen
France	Hopital Gabriel Montpied	Clermont Ferrand
France	Hopital general du Bocage	Dijon
France	Hopital Pierre Wertheimer	Lyon
France	Hopital de la Timone	Marseille
France	Hopital Gui de Chauliac	Montpellier
France	Hopital Central	Nancy
France	Hopital Nord Laennec	Nantes
France	Hopital Pasteur	Nice
France	Fondation Rothschild	Paris
France	Groupe hospitalier la Pitié-Salpêtrière	Paris
France	Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye	Poissy
France	Hopital Maison Blanche	Reims
France	Hopital Pontchaillou	Rennes
France	Hopital Hautepierre	Strasbourg
France	Hopital Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
MedDay Pharmaceuticals SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brain MRI	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.	Baseline, 12 months
Primary	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	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.	Baseline, 12 months, 24 months
Secondary	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).	12 months, 24 months
Secondary	Unidimensional Fatigue Impact Scale (U-FIS)	The U-FIS has 22-items measuring the impact of fatigue.	Baseline, 12 months, 24 months
Secondary	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.	Baseline, 12 months, 24 months
Secondary	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.	Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

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