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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02369926
• Other study ID #: TLS-002
• Status: Recruiting
• Phase: Phase 2
• First received: February 10, 2015
• Last updated: October 10, 2017
• Start date: November 2014

Study information

• Verified date: October 2017
• Source: Transparency Life Sciences
• Contact: Ruthie Perez
• Email: ruthie.perez[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Transparency Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of mMSFC Tally	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.	Week 6
Primary	MSFC Score Comparison	mMSFC scores will be compared to MSFC scores for proof of calibration.	Week 6
Primary	Mobile Timed Walk Test Value Comparison	Mobile timed walk times will be compared to 25-foot timed walk test times for proof of calibration.	Week 6
Primary	Mobile 9-hole Peg Test Time Comparison	Mobile 9HPT time will be compared to 9 HPT time for proof of calibration.	Week 6
Primary	Mobile Paced Auditory Serial Addition Test Score Comparison	Mobile PASAT3 scores will be compared to PASAT3 scores for proof of calibration.	Week 6