Inspire Upper Airway Stimulation Post-FDA Approval Study
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of the Inspire Upper Airway Stimulation System to treat obstructive sleep apnea.
A Non-randomized, Exploratory, Study to Assess Clinical Response to Gilenya® (Fingolimod) in a Cohort of Relapsing Remitting Hispanic MS Forms
The primary objective of this study is to determine the success of Gilenya® (fingolimod)
treatment in patients with MS of Hispanic descent relative to their ancestral background.
Therapeutic success will be determined by annualized relapse rate (ARR; defined as the
number of relapses divided by the person years followed) after initiation of treatment with
Gilenya® (fingolimod)in comparison to the relapse rate in the previous 12 months. This will
be determined based on medical chart extraction, in-person assessment and regular clinical
follow-up.
A secondary objective of this study is to investigate whether the efficacy of Gilenya®
(fingolimod) is superior or equal in HW which have higher loads of Amerindian versus
Caucasian background with opticospinal MS (OSMS-NMO neg) versus classical MS (CMS) in the
first 12 months using radiological and clinical parameters. The following measures will be
obtained:
1. Number of relapse-free patients over the investigational period
2. Site of relapse defined as brain or spinal cord.
3. Sustained Disability progression will be defined as a one point (1) increase from
baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5)
increase in patients with baseline EDSS score of 5-5.5 or above after 3 months.
4. MRI changes as described as number of new T2 lesions and number of Gd-enhancing lesions
after 12 months from baseline.
Unknown status | Multiple Sclerosis | Not Multisite
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