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

Interventional study

Status:
Completed
Conditions:
Multiple Sclerosis (MS)
Enrollment:
123 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-397
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

 

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

More information about this study

clinicaltrials.gov