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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Multiple Sclerosis Functional Composite

Mobile Multiple Sclerosis Functional Composite

About this trial

This is an interventional health services research trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring multiple sclerosis, telemedicine, remote monitoring, lisinopril

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and females between the ages of 18 and 64.
Documented informed consent
Documented diagnosis of RRMS via 2010 McDonald Criteria
Normal blood pressure at baseline: 90-140 mmHg systolic AND 60-90 mmHg diastolic
Baseline score of 0-5.5 on Kurtzke's Expanded Disability Status Scale (EDSS)
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:

Hypotensive at baseline: <90 mmHg systolic or <60 mmHg diastolic
Hypertensive at baseline: >140 mmHg systolic or >90 mmHg diastolic
Bradycardia at baseline: < 50 bpm

Sites / Locations

Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1

Group 2

Arm 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.

Outcomes

Primary Outcome Measures

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.

MSFC Score Comparison

mMSFC scores will be compared to MSFC scores for proof of calibration.

Mobile Timed Walk Test Value Comparison

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

Mobile 9HPT time will be compared to 9 HPT time for proof of calibration.

Mobile Paced Auditory Serial Addition Test Score Comparison

Mobile PASAT3 scores will be compared to PASAT3 scores for proof of calibration.

Secondary Outcome Measures

Full Information

NCT ID

NCT02369926

First Posted

February 10, 2015

Last Updated

October 10, 2017

Sponsor

Transparency Life Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02369926

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Transparency Life Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Relapsing-Remitting

Keywords

multiple sclerosis, telemedicine, remote monitoring, lisinopril

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm Description

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Multiple Sclerosis Functional Composite

Other Intervention Name(s)

MSFC

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Mobile Multiple Sclerosis Functional Composite

Other Intervention Name(s)

mMSFC

Intervention Description

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 Information:

Title

Safety of mMSFC Tally

Description

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.

Time Frame

Week 6

Title

MSFC Score Comparison

Description

mMSFC scores will be compared to MSFC scores for proof of calibration.

Time Frame

Week 6

Title

Mobile Timed Walk Test Value Comparison

Description

Mobile timed walk times will be compared to 25-foot timed walk test times for proof of calibration.

Time Frame

Week 6

Title

Mobile 9-hole Peg Test Time Comparison

Description

Mobile 9HPT time will be compared to 9 HPT time for proof of calibration.

Time Frame

Week 6

Title

Mobile Paced Auditory Serial Addition Test Score Comparison

Description

Mobile PASAT3 scores will be compared to PASAT3 scores for proof of calibration.

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females between the ages of 18 and 64. Documented informed consent Documented diagnosis of RRMS via 2010 McDonald Criteria Normal blood pressure at baseline: 90-140 mmHg systolic AND 60-90 mmHg diastolic Baseline score of 0-5.5 on Kurtzke's Expanded Disability Status Scale (EDSS) 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: Hypotensive at baseline: <90 mmHg systolic or <60 mmHg diastolic Hypertensive at baseline: >140 mmHg systolic or >90 mmHg diastolic Bradycardia at baseline: < 50 bpm

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ruthie Perez

ruthie.perez@mssm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Tarah Gustafson

tarah.gustafson@mssm.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tomasz Sablinski, MD, PhD

Organizational Affiliation

Transparency Life Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tarah Gustafson

tarah.gustafson@mssm.edu

First Name & Middle Initial & Last Name & Degree

Fred Lublin, MD

12. IPD Sharing Statement

Learn more about this trial

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

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