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

Phase 2

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Procedure: Multiple Sclerosis Functional Composite; Procedure: Mobile Multiple Sclerosis Functional Composite

• Registration Number: NCT02369926
• Lead Sponsor: Transparency Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-24
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-12
• Primary Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Multiple Sclerosis Functional Composite	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.
Group 2	Multiple Sclerosis Functional Composite	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.
Group 1	Mobile Multiple Sclerosis Functional Composite	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.
Group 2	Mobile Multiple Sclerosis Functional Composite	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States