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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02369926

Enrollment

Registered

2015-02-24

Start date

2014-11-30

Completion date

Unknown

Last updated

2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

multiple sclerosis, telemedicine, remote monitoring, lisinopril

Brief 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.

Interventions

PROCEDUREMultiple 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.

PROCEDUREMobile 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

1. Males and females between the ages of 18 and 64. 2. Documented informed consent 3. Documented diagnosis of RRMS via 2010 McDonald Criteria 4. Normal blood pressure at baseline: 90-140 mmHg systolic AND 60-90 mmHg diastolic 5. Baseline score of 0-5.5 on Kurtzke's Expanded Disability Status Scale (EDSS) 6. 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.

Exclusion criteria

1. Hypotensive at baseline: \<90 mmHg systolic or \<60 mmHg diastolic 2. Hypertensive at baseline: \>140 mmHg systolic or \>90 mmHg diastolic 3. Bradycardia at baseline: \< 50 bpm

Design outcomes

Primary

Measure	Time frame	Description
Safety of mMSFC Tally	Week 6	Safety of remote video administration of the mMSFC will be calculated at the end of the study by calculating and comparing the instances of balance-related safety issues.
MSFC Score Comparison	Week 6	mMSFC scores will be compared to MSFC scores for proof of calibration.
Mobile Timed Walk Test Value Comparison	Week 6	Mobile timed walk times will be compared to 25-foot timed walk test times for proof of calibration.
Mobile 9-hole Peg Test Time Comparison	Week 6	Mobile 9HPT time will be compared to 9 HPT time for proof of calibration.
Mobile Paced Auditory Serial Addition Test Score Comparison	Week 6	Mobile PASAT3 scores will be compared to PASAT3 scores for proof of calibration.

Countries

United States

Contacts

Primary ContactRuthie Perez

ruthie.perez@mssm.edu

Backup ContactTarah Gustafson

tarah.gustafson@mssm.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026