This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    lisinopril multiple sclerosis
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Transparency Life Sciences
Sponsor:
Information provided by (Responsible Party):
Transparency Life Sciences
ClinicalTrials.gov Identifier:
NCT02369926
First received: February 10, 2015
Last updated: October 21, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting Procedure: Multiple Sclerosis Functional Composite Procedure: Mobile Multiple Sclerosis Functional Composite Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Transparency Life Sciences:

Primary Outcome Measures:
  • 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.

  • MSFC Score Comparison [ Time Frame: Week 6 ]
    mMSFC scores will be compared to MSFC scores for proof of calibration.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 20
Study Start Date: November 2014
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: mMSFC

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02369926

Contacts
Contact: Ruthie Perez ruthie.perez@mssm.edu
Contact: Tarah Gustafson tarah.gustafson@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Tarah Gustafson       tarah.gustafson@mssm.edu   
Principal Investigator: Fred Lublin, MD         
Sponsors and Collaborators
Transparency Life Sciences
Investigators
Study Director: Tomasz Sablinski, MD, PhD Transparency Life Sciences
  More Information

Responsible Party: Transparency Life Sciences
ClinicalTrials.gov Identifier: NCT02369926     History of Changes
Other Study ID Numbers: TLS-002
Study First Received: February 10, 2015
Last Updated: October 21, 2016

Keywords provided by Transparency Life Sciences:
multiple sclerosis
telemedicine
remote monitoring
lisinopril

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Lisinopril
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 19, 2017