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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

18 Years
75 Years
Not Enrolling
Multiple Sclerosis

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Trial Information

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.

Inclusion Criteria:

- This trial treats subjects with relapsing variants of MS, including
relapsing-remitting, progressive-relapsing, transitional, or secondary progressive
MS, not amenable to other aggressive therapy, prior relapses, EDSS 2.5-7.0 inclusive.
Most will have generally moderate to severe disability at EDSS >3 (EDSS 2.5-3 if
significant cognitive complaints or MRI activity). Alemtuzumab experienced subjects
at any EDSS level previously treated with alemtuzumab outside of a clinical trial are
also eligible.

Inclusion Criteria for Alemtuzumab Experienced Subjects:

- All clinic patients who have been treated with alemtuzumab with our clinic method
will be offered participation in the study, and may leave the study if desired after
collection of data. Subjects wishing to sign informed consent but who have moved out
of the region and are unable to be seen personally may be interviewed by telephone
and included in the database after signing informed consent.

Exclusion Criteria:

- Subjects are excluded if they have purely slowly progressive or definite primary
progressive MS (e.g. slowly progressive corticosteroid unresponsive myelopathy) with
no documented recent relapses, advanced age (over 75 years), legal minor status, or a
recognized contraindication to alemtuzumab (active infection, malignancy (other than
considered surgical cures by oncologist or basal cell carcinoma), uncontrolled
bleeding disorder, planned pregnancy in immediate future or unwillingness to use
contraception, or if they are in another alemtuzumab clinical trial.

- Prior autoimmunity which is in remission or controlled will be considered at the
investigator's discretion.

- Our clinic experience is that prior Grave's disease is not a contraindication to
alemtuzumab therapy.

- We have not previously excluded patients from alemtuzumab on the basis of any humoral
immune marker (e.g. anti-thyroid), and therefore do not plan to perform such testing
in screening.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Neurostatus Expanded Disability Status Scale

Outcome Time Frame:

Baseline and every 6 months over 5 years

Safety Issue:


Principal Investigator

Samuel F Hunter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Advanced Neurosciences Institute (ANI)


United States: Institutional Review Board

Study ID:




Start Date:

September 2012

Completion Date:

Related Keywords:

  • Multiple Sclerosis
  • Treatment Refractory
  • Multiple Sclerosis
  • Sclerosis



Advanced Neurosciences Institute Franklin, Tennessee  37064