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

NCT01624714 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-11

No results posted yet for this study

Summary

The purpose of this study is to treat prospectively documented clinic patients with treatment-refractory multiple sclerosis that are naïve to alemtuzumab. Alemtuzumab shows efficacy and rate of serious adverse events (SAEs) which is equivalent or better than standard of care treatment strategies used previously for treatment-refractory multiple sclerosis.

Conditions

Interventions

DRUG

Alemtuzumab

alemtuzumab 12 mg IV x 5 daily doses at baseline, alemtuzumab 12 mg IV x 3 daily doses at month 12

DRUG

Alemtuzumab immunotherapy

Alemtuzumab 60 mg over 5 days for first annual cycle, then 36 mg over 3 days for subsequent annual cycle, and as needed cycles in subsequent years.

Sponsors & Collaborators

  • Samuel Forrester Hunter, MD, PhD

    lead OTHER

Principal Investigators

  • Samuel F Hunter, MD · Advanced Neurosciences Institute (ANI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-04-30
Completion
2017-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01624714 on ClinicalTrials.gov