Phase I Trial Monitoring Efficacy and Safety in Treatment of Alemtuzumab Naive Subjects and Data Collecting and Monitoring of Alemtuzumab Experienced Subjects With Refractory Multiple Sclerosis
Hypothesis Alemtuzumab manifests efficacy (e.g. improved MS Severity score, and treatment
stability in relapse rate and Expanded Disability Status Scale [EDSS] progression) and
serious adverse events (SAEs) equivalent or better than standard of care treatment
strategies used prior to treatment for treatment-refractory multiple sclerosis.
Objectives Treat prospectively documented clinic patients treatment-refractory multiple
sclerosis that are naïve to alemtuzumab.
Obtain retrospective disability, relapse, and adverse events in alemtuzumab-experienced
subjects previously treated outside of clinical trial settings for treatment-refractory MS.
Obtain prospective safety and efficacy data for multiple sclerosis symptoms, disability, and
adverse effects following the use of alemtuzumab for treatment-refractory MS in a population
with exposures to prior cytotoxic and monoclonal antibody therapy.
Transition alemtuzumab-experienced clinic patients into a clinical trial setting for
additional treatment with alemtuzumab as needed for refractory MS.
Coprimary outcomes will be: change in EDSS and converted EDSS to MS Severity scale.
Secondary outcomes: changes in annualized relapse rate, days of high dose corticosteroids,
MRI-based cerebral volumes and burden of disease (in selected subjects), serious adverse
events, and corticosteroid use. A questionnaire will be used to assess patient satisfaction
with alemtuzumab as compared to prior therapies.
Safety outcomes will be assessed and tabulated.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in Neurostatus Expanded Disability Status Scale
Baseline and every 6 months over 5 years
Samuel F Hunter, MD
Advanced Neurosciences Institute (ANI)
United States: Institutional Review Board
|Advanced Neurosciences Institute||Franklin, Tennessee 37064|