Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months

Multiple Sclerosis Clinical Trial

— GZA  

Official title:

Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881191
• Other study ID #: GZ-2013-10958
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: February 11, 2016
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will evaluate the effects of Aubagio on changes in the brain using MRI.

Description:

Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a questionnaire on environmental risk factors to evaluate changes in the brain and on disease progression. A healthy control group will also complete the same testing regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects aged 18-65

• Clinically definite MS according to the Polman criteria, 52

• Relapsing MS or Healthy Control (no neurological disorders)

• Expanded Disability Status Scale (EDSS) scores =5.5

• Disease duration <30 years

• Normal kidney function (creatinine clearance >59 mL/min) (patients only)

• Signed informed consent

• None of the exclusion criteria

Exclusion Criteria:

• MS patients with hepatic impairment

• Nursing mothers or pregnant women who will need to undergo 12 months follow-up

• Women of childbearing potential not using reliable contraception

• Patients currently treated with leflunomide

• Serum alanine aminotransferase (ALT) >1.5 times the upper limit of normal

• A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment

• Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol

• Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study

• Other pathology related to MRI abnormalities

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• MRI

Locations

Country	Name	City	State
United States	Buffalo Neuroimaging Analysis Center	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS) using MRI.		baseline, 6 month and 12 month	No
Secondary	The secondary objective of this study is to define the effect of teriflunomide on subcortical deep gray matter (SDGM) pathology using MRI over 12 months.		baseline, month 6 and month 12	No