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

MedDay Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: MD1003 100mg capsule; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02220933

2013-002113-35 (EudraCT Number)

MD1003CT2013-02MS-SPI

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

MD1003

Experimental group

Description:

MD1003 100mg capsules, 1 capsule tid for 24 months

Treatment:

Drug: MD1003 100mg capsule

Placebo

Placebo Comparator group

Description:

Placebo capsule, 1 capsule tid for 12 months, then switch to MD1003 100mg capsule, 1 capsule tid for 12 months

Treatment:

Drug: Placebo

Drug: MD1003 100mg capsule