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

October 10, 2017 updated by: Transparency Life Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Fred Lublin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
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.
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.
Other Names:
  • MSFC
Procedure: 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.
Other Names:
  • mMSFC
Active Comparator: Group 2
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.
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.
Other Names:
  • MSFC
Procedure: 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.
Other Names:
  • mMSFC

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transparency Life Sciences

Investigators

  • Study Director: Tomasz Sablinski, MD, PhD, Transparency Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLS-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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