Recruiting
Phase 2

Lisinopril

Sponsor:

Transparency Life Sciences

Code:

NCT02369926

Conditions

Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Multiple Sclerosis Functional Composite

Mobile Multiple Sclerosis Functional Composite

Study Details

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study ID

NCT02369926

Start date

Nov, 2014

Status verified date

Oct, 2017

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Group 1

Participants will be separated into two groups for scheduling purposes. Each group will complete the Multiple Sclerosis Functional Composite (MSFC) once weekly at the study site and once weekly at home for three weeks. They will alternate their visit dates with Group 2.

active comparator: Group 2

Participants will be separated into two groups for scheduling purposes. Each group will complete the Multiple Sclerosis Functional Composite (MSFC) once weekly at the study site and once weekly at home for three weeks. They will alternate their visit dates with Group 1.

Interventions

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.

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.

Primary outcome measure

  • Safety of mMSFC Tally [ Time Frame: Week 6 ]
  • MSFC Score Comparison [ Time Frame: Week 6 ]
  • Mobile Timed Walk Test Value Comparison [ Time Frame: Week 6 ]
  • Mobile 9-hole Peg Test Time Comparison [ Time Frame: Week 6 ]
  • Mobile Paced Auditory Serial Addition Test Score Comparison [ Time Frame: Week 6 ]

Central Contacts and Locations

Central contacts

Ruthie Perez

ruthie.perez@mssm.edu

Tarah Gustafson

tarah.gustafson@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Tarah Gustafson

tarah.gustafson@mssm.edu

Principal Investigator:

Fred Lublin, MD

More Information

Sponsor

Transparency Life Sciences

Last update posted

Oct 12, 2017

Last verified

Oct, 2017

Keywords

  • multiple sclerosis
  • telemedicine
  • remote monitoring
  • lisinopril

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Transparency Life Sciences on 2017-10-12.