NCT02369926

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

Phase 2a, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety, Tolerability, and Proof-of-Concept Efficacy of Lisinopril in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS), Stage 1

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Transparency Life Sciences · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-06-01
• First posted: 2015-02-24
• Last updated: 2017-10-12

Locations

1 site across 1 country: United States