Recruiting

Gilenya

Sponsor:

McGill University

Code:

NCT02408380

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis.

Conditions

Multiple Sclerosis

Study ID

NCT02408380

Start date

Sep, 2014

Status verified date

Mar, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Treatment with Gilenya

Exclusion Criteria:

  • Subject is under 18 or over 65.
  • Subject has less than 4 weeks of discontinuation with steroid treatment for a relapse.
  • Subject cannot communicate reliably with investigator.
  • Vulnerable subjects exclude, namely patients defined as those without freedom by the law (e.g. prisoners or by administrative decision) or people hospitalized without their consent.

Study Design

Enrollment

216 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in expression of a biomarker signature [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Leslie Fitz-Gerald, MSc.

514-398-7192leslie.fitz-gerald@mail.mcgill.ca

Locations

McGill University

Recruiting

Montreal, Quebec, Canada, H3A 2B4

Contacts

Leslie Fitz-Gerald, MSc

5143987192leslie.fitz-gerald@mail.mcgill.ca

Principal Investigator:

David Haegert, MD

More Information

Sponsor

McGill University

Last update posted

Apr 3, 2015

Last verified

Mar, 2015

Keywords

  • biomarker
  • disease progression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2015-04-03.