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

NCT01881191 | Completed

• 1 other identifier: GZ-2013-10958
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; relapsing remitting; MRI; teriflunomide; aubagio; gray matter atrophy; gray matter pathology

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Aubagio MRI

Patients with relapsing-remitting multiple sclerosis who take Aubagio will have an MRI, eye test, blood drawn, and complete a questionnaire.

Other: MRI

Healthy controls

Subjects who are otherwise healthy, without neurological disorders will have an MRI, eye test, blood drawn, and complete a questionnaire.

Other: MRI

Interventions

MRI OTHER

Aubagio MRI; Healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Aubagio as their disease modifying therapy. Healthy controls from the general population.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, 14203, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum to be retained.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Robert Zivadinov, MD,PhD,FAAN

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Buffalo Neuroimaging Analysis Center, Professor

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 19, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

US (1)