NCT03737812

A Study to Assess the Safety and Efficacy of an Active Drug When Added to Standard of Care in Progressive Forms of Multiple Sclerosis

Brief summary

The purpose of this study is to evaluate the safety and efficacy of an active drug in subjects with progressive Multiple Sclerosis (PMS).

Interventional study

Status:
Active, not recruiting
Conditions:
Multiple Sclerosis (MS)
Enrollment:
90 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-397
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 65 Years.

Inclusion Criteria:

- Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing
secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24
months.

- Evidence of physical disability according to Expanded Disability Status Scale (EDSS)
or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

Exclusion Criteria:

- Treatment with any of the following within the 6 months prior to Screening:
natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil;
intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral,
or intrathecal corticosteroids for the purposes of disease modification.

- Treatment with the following within 1 year prior to Screening: cyclophosphamide or
alemtuzumab.

All the cities where the clinical studies are located

Vancouver - V6T 1Z3

London - N6A 5A5

Ottawa - K1H 8L6

Toronto - M5B 1W8

Greenfield Park - J4V 2J2

Montreal - H2X 0A9

Montreal - H3A 2B4