Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01624714
• Date of registration: 18/06/2012
• Prospective Registration: Yes
• Primary sponsor: Samuel Forrester Hunter, MD, PhD
• Public title: Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced Subjects
• Scientific title: 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
• Date of first enrolment: September 2012
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01624714
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Samuel F Hunter, MD
• Affiliation: Advanced Neurosciences Institute (ANI)

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Alemtuzumab

Drug: Alemtuzumab immunotherapy

Primary Outcome(s)

Change in Neurostatus Expanded Disability Status Scale [Time Frame: Baseline and every 6 months over 5 years]

Change in MS Severity Scale [Time Frame: Baseline and every 6 months for 5 years]

Secondary Outcome(s)

Number of treatment days with high dose corticosteroids [Time Frame: Every 6 months during study]

Change in annualized relapse rate [Time Frame: Every 6 months during study]

Rate of serious adverse events [Time Frame: Duration of study]

MRI-based cerebral volumes and burden of disease (in selected subjects) [Time Frame: Baseline and yearly X 5 years]

Secondary ID(s)

NPI-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors