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

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 unknownPhase 2Relapsing MSNCT02369926

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Multiple Sclerosis Functional Composite
  • Mobile Multiple Sclerosis Functional Composite

What it measured

Main measures

  • Safety of mMSFC Tally

    Week 6

    Walking and mobilitySafety

  • MSFC Score Comparison

    Week 6

    Disability progression

  • Mobile Timed Walk Test Value Comparison

    Week 6

    Walking and mobility

  • Mobile 9-hole Peg Test Time Comparison

    Week 6

    Disability progression

  • Mobile Paced Auditory Serial Addition Test Score Comparison

    Week 6

Who could take part

Relapsing MS · 18 to 64

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Nov 2014

      2. Main results due

        Jun 2018

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