NCT03737851

A Study to Assess the Safety and Efficacy of an Active Drug When Added to Standard of Care in Relapsing 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 relapsing Multiple Sclerosis (RMS).

Interventional

Interventional study

Status:
Completed
Conditions:
Multiple Sclerosis (MS)
Enrollment:
208 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M18-918
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:

- Participant has diagnosis of relapsing remitting multiple sclerosis (RRMS) or
secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24
months.

- Participant has cranial magnetic resonance imaging (MRI) demonstrating lesion(s)
consistent with multiple sclerosis (MS).

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

Exclusion Criteria:

- Participants must not have experienced or be recovering from a clinical MS relapse within
6 months of Screening.

All the cities where the clinical studies are located

Ottawa - K1H 8L6

More information about this study

clinicaltrials.gov