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

Transparency Life Sciences

Status and phase: Unknown; Phase 2

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Procedure: Mobile Multiple Sclerosis Functional Composite; Procedure: Multiple Sclerosis Functional Composite

Study type: Interventional

Funder types: Industry

Identifiers

NCT02369926

TLS-002

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Procedure: Multiple Sclerosis Functional Composite

Procedure: Mobile Multiple Sclerosis Functional Composite

Group 2

Active Comparator group

Description:

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.

Treatment:

Procedure: Multiple Sclerosis Functional Composite

Procedure: Mobile Multiple Sclerosis Functional Composite