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Motor Evoked Potentials as a Biomarker in Alemtuzumab Treated Multiple Sclerosis Patients

NCT02623946 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-07-28

No results posted yet for this study

Summary

Study Design:

Phase 4, pilot, single center, observational study. MEP's will be obtained twice, two weeks apart at baseline and every 6 months for 36 months (total of 14 sessions of MEP's)

MEP's will include:

1. Onset latencies and CMCT to bilateral abductor pollicis brevis and tibialis anterior muscles
2. MEP amplitudes and the ratio of the central to peripherally obtained motor amplitudes (MEP-M ratio) to bilateral abductor pollicis brevis and tibialis anterior muscles Clinical measures (EDSS, MEP's, T25FWT, 6MWT, 9HPT) will be obtained at baseline and every 6 months for 36 months.

Study location: Single center in Canada

Study Objectives:

Primary: To evaluate the reliability of MEP's in Alemtuzumab treated MS patients over a 36 month period.

Secondary: To determine the degree of correlation between MEP's and presently used clinical measures of efficacy (EDSS, 6MWT, T25FWT, 9HPT) and to determine if MEP's can predict who will require a third cycle of Alemtuzumab.

Conditions

Sponsors & Collaborators

  • CogState Ltd.

    collaborator INDUSTRY

  • Clinique Neuro-Outaouais

    lead OTHER

Principal Investigators

  • Francois H Jacques, MD · Clinic Neuro-Outaouais; Director

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-12-09
Completion
2021-02-28

Countries

  • Canada

Study Locations

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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 NCT02623946 on ClinicalTrials.gov