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Endpoint Calibration for a Phase 2 Study of Lisinopril in Multiple Sclerosis

NCT02369926 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-10-12

No results posted yet for this study

Summary

This study aims to calibrate the Multiple Sclerosis Functional Composite (MSFC) for home implementation in a phase 2 trial of lisinopril in multiple sclerosis. In this initial stage, participants are required to travel to the study site one day a week for three weeks to complete the MSFC. They are also required to complete the MSFC at home once weekly for three weeks using remote sensing technology and video conferencing.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

PROCEDURE

Multiple Sclerosis Functional Composite

The MSFC is a diagnostic test that measures multiple sclerosis symptoms. It includes a timed walk test, 9-hole peg test, and paced auditory serial addition test. The MSFC is administered in-person at the study site.

PROCEDURE

Mobile Multiple Sclerosis Functional Composite

The mMSFC is a diagnostic test that measures multiple sclerosis symptoms from. It includes a timed walk test, 9-hole peg test, and paced auditory serial addition test. All aspects of this exam are completed from a participant's home using remote sensing technology and video conferencing.

Sponsors & Collaborators

  • Transparency Life Sciences

    lead INDUSTRY

Principal Investigators

  • Tomasz Sablinski, MD, PhD · Transparency Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-06-30

Countries

  • United States

Study Locations

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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 NCT02369926 on ClinicalTrials.gov