Status:
COMPLETED
Gilenya's Impact on Cognitive Function and Thalamic Volumes
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This evaluation will be a one-year feasibility study to characterize the neuroprotective benefits of Gilenya and its effects on cognition and grey matter volumes. The study will enroll 15 patients wit...
Detailed Description
Cognitive impairment is a well-recognized manifestation of multiple sclerosis (MS) with prevalence estimates ranging from 43 to 70%. It is also known to occur as early as the first demyelinating event...
Eligibility Criteria
Inclusion
- Inclusion Criteria (MS Patients):
- RRMS phenotype
- Treated with Gilenya for ≥6 months at the time of the baseline visit.
- Age 18-50 inclusive.
- EDSS 0-4.0
- Disease duration of 5-15 years.
- At least 12 years of education (high school diploma or general equivalency diploma).
- Physically capable of completing neurometric testing and MRI studies.
- Inclusion Criteria (Healthy Controls):
- Age 18-50 inclusive.
- At least 12 years of education (high school diploma or general equivalency diploma)
- Physically capable of completing neurometric testing and MRI studies.
- Exclusion Criteria (MS Patients):
- Contraindication to MRI (e.g. metal implants)
- Current use of immunomodulatory or immunosuppressant medications other than Gilenya.
- Disease of the central nervous system other than MS (e.g. Alzheimer disease, stroke, epilepsy).
- Use of anti-psychotic or psychostimulant medications. Patients started on modafinil or armodafinil more than six months prior to enrollment will not be excluded.
- Ongoing major depressive disorder that, in the opinion of the investigator, may affect cognitive functioning.
- MS relapse within 90 days of study entry.
- Treatment with corticosteroids within 90 days of study entry.
- Current illicit substance use.
- History of alcohol or drug abuse.
- Exclusion Criteria (Healthy Controls):
- Contraindication to MRI (e.g. metal implants, claustrophobia).
- Disease of the central nervous system (e.g. MS, Alzheimer disease, stroke, epilepsy).
- Use of anti-psychotic or psychostimulant medications. Patients started on modafinil or armodafinil more than six months ago will not be excluded.
- Ongoing major depressive disorder that, in the opinion of the investigator, may affect cognitive functioning.
- Current illicit substance use.
- History of alcohol or drug abuse.
Exclusion
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03243721
Start Date
October 20 2017
End Date
November 12 2019
Last Update
September 5 2021
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195