Multiple Sclerosis Clinical Trial
Official title:
Motor Evoked Potentials as a Biomarker in Alemtuzumab Treated Multiple Sclerosis Patients
NCT number | NCT02623946 |
Other study ID # | CNO-004 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | February 2021 |
Verified date | July 2020 |
Source | Clinique Neuro-Outaouais |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 2021 |
Est. primary completion date | December 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of MS (McDonald criteria) and of age 18 and older; - Subjects who meet the prescribing criteria for Alemtuzumab as per product monograph; - An EDSS of 5.0 or less and a pyramidal system functional assessment score of 2 or greater; - Subject who have received the first cycle of Alemtuzumab within the last 3 months. Exclusion Criteria: - Subjects who have begun using extended release Fampridine within 2 months of study baseline visit (Patient on a stable dose of extended release Fampridine for more than 2 months can enter the study); - Subjects with MSSS (Multiple Sclerosis Severity Score) less than 4.0; - Subject with other medical conditions that involve the CST's; - Any other condition that would preclude them from undergoing the MEP's and/or MRI. |
Country | Name | City | State |
---|---|---|---|
Canada | Clinique Neuro-Outaouais | Gatineau | Quebec |
Lead Sponsor | Collaborator |
---|---|
Clinique Neuro-Outaouais | CogState Ltd. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intrapatient correlation coefficient of MEP's | to measure within subject correlation a two-way fixed Intraclass Correlation (ICC) will be calculated for each of 10 participants across sessions measured two weeks apart. The ICC will provide an estimate of the variance of each individual's motor evoked potentials at each paired time point. | obtained between two assessments done two weeks apart | |
Secondary | Correlation coefficient between the changes from baseline MEP results and clinical measures (EDSS, 6MW, T25FWT, 9HPT) | to measure the relationship between MEP change scores and the change scores of the clinical measures, several correlations will be run across 6 months intervals over the 36 month period. The corrrelation between the individual changes in MEP results and the propensity to require a third cycle of alemtuzumab will also be calcutlated. | obtained every 6 months for 36 months | |
Secondary | Correlation between the change in the conduction index and the change in clincal measures | to measure the correlation betwen the conduction index results and the clinical measures and the change in the conduction index over time and the change in the clinical measures over the 36month period. | obtained at baseline and every 6 months over 36 months |
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