Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02307877 : Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate
PhaseN/A
AgesMin: 18 Years Max: 55 Years
Eligibility
Inclusion Criteria:

- Must be able to provide written informed consent

- Between 18-55 years of age at the time of informed consent.

- Diagnosis of any form of MS as defined by the 2010 revised McDonald criteria

- Currently taking fingolimod or glatiramer acetate for a minimum of two years at the
time of the initial baseline visit

- Must be willing and able to comply with the protocol requirements for the duration of
the study

Exclusion Criteria:

- -Patients suffering from comorbidities that could confound the MRI outcomes or are
(relative) contraindicated to receive treatment with fingolimod such as diabetes,
myocardial infarction, unstable angina, transient ischemic attack, decompensated
heart failure, history of Mobitz Type II 2nd or 3rd degree atrioventricular block or
sick sinus syndrome, history of stroke, traumatic brain injury, encephalitis, and
dementia (not related to MS).

- Systemic steroid used (oral or IV) within 30 days of the baseline visit.

- Patients who were ever treated with chemotherapy.

- Patients ever having undergone cranial radiation, or intracranial surgery.

- Patients who are unable to tolerate an MRI scan. -Patient who is pregnant or
breastfeeding or planning on pregnancy during the study period-

- Patient who is decisionally challenged, illiterate or blind

- Patient is non-English speaking (as the PRO instruments are only validated in
English)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02307877      |      Link to official Clinicaltrials.gov listing
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