Clinical trial NCT02220933: Effect of MD1003 in Spinal Progressive Multiple Sclerosis
Official title: Effect of MD1003 in Spinal Progressive Multiple Sclerosis: a Pivotal Randomized Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
EDSS
Lead sponsor: MedDay Pharmaceuticals SA
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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."

Primary outcomes:
measure: Proportion of patients improved on either Expanded Disability Status Scale (EDSS) or time to walk 25 feet (TW25)
timeFrame: up to 24 months
Secondary outcomes:
measure: Multiple Sclerosis Walking Scale (MSWS)
timeFrame: Baseline, 12 months, 24 months
measure: Clinical Global Impression / Subject Global Impression (CGI / SGI)
timeFrame: 12 months, 24 months
measure: Unidimensional Fatigue Impact Scale (U-FIS)
timeFrame: Baseline, 12 months, 24 months
measure: Multiple Sclerosis Quality of Life Scale (SEP-59)
timeFrame: Baseline, 12 months, 24 months
measure: Hole Peg Test (9-HPT)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Other outcomes:
measure: Brain MRI
timeFrame: Baseline, 12 months
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Caen
country: France
facility: Hopital de la cote de Nacre
city: Clermont Ferrand
country: France
facility: Hopital Gabriel Montpied
city: Dijon
country: France
facility: Hopital general du Bocage
city: Lyon
country: France
facility: Hopital Pierre Wertheimer
city: Marseille
country: France
facility: Hopital de la Timone
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
city: Nancy
country: France
facility: Hopital Central
city: Nantes
country: France
facility: Hopital Nord Laennec
city: Nice
country: France
facility: Hopital Pasteur
city: Paris
country: France
facility: Groupe hospitalier la Pitié-Salpêtrière
city: Paris
country: France
facility: Fondation Rothschild
city: Poissy
country: France
facility: Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye
city: Reims
country: France
facility: Hopital Maison Blanche
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Strasbourg
country: France
facility: Hopital Hautepierre
city: Toulouse
country: France
facility: Hopital Purpan
Study officials:
affiliation: Hopital Maison Blanche, Reims, France
name: Ayman Tourbah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medday SAS, Paris, France
name: Frederic Sedel, MD, PhD
role: STUDY_DIRECTOR
References: