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

Status unconfirmed · Phase 2

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT02369926

Run by

Transparency Life Sciences

People needed

20

Starts

2014-11-01

Last updated by the study team

2017-10-12

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females between the ages of 18 and 64.
• Documented informed consent
• Documented diagnosis of RRMS via 2010 McDonald Criteria
• Normal blood pressure at baseline: 90-140 mmHg systolic AND 60-90 mmHg diastolic
• Baseline score of 0-5.5 on Kurtzke's Expanded Disability Status Scale (EDSS)
• Availability of a person in the home who is physically able and willing to steady the subject if s/he loses balance during the walk test.

You may not qualify if…

• Hypotensive at baseline: <90 mmHg systolic or <60 mmHg diastolic
• Hypertensive at baseline: >140 mmHg systolic or >90 mmHg diastolic
• Bradycardia at baseline: < 50 bpm

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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