Status:
COMPLETED
Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate
Lead Sponsor:
University of Colorado, Denver
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Brief Summary
Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate have not been examined in patients with relapsing forms of multiple sclerosis (MS). As patients on long ter...
Eligibility Criteria
Inclusion
- 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
- 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,
- sick sinus syndrome,
- history of stroke,
- history of traumatic brain injury,
- history of encephalitis,
- dementia (not related to MS).
- Systemic steroid used (oral or IV) within 30 days of the baseline visit.
- Ever treated with chemotherapy.
- Ever having undergone cranial radiation, or intracranial surgery.
- Unable to tolerate an MRI scan.
- Is pregnant or breastfeeding or planning on pregnancy during the study period.
- Is decisionally challenged, illiterate or blind
- Is non-English speaking (as the PRO instruments are only validated in English)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT02307877
Start Date
September 1 2014
End Date
May 1 2018
Last Update
March 8 2022
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045