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

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ClinicalTrials.gov Identifier: NCT02369926
Recruitment Status : Unknown
Verified October 2017 by Transparency Life Sciences.
Recruitment status was:  Recruiting
First Posted : February 24, 2015
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Transparency Life Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Procedure: Multiple Sclerosis Functional Composite Procedure: Mobile Multiple Sclerosis Functional Composite Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : November 2014
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Lisinopril

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

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

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369926


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

Locations
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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
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Study Director: Tomasz Sablinski, MD, PhD Transparency Life Sciences
More Information
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Responsible Party: Transparency Life Sciences
ClinicalTrials.gov Identifier: NCT02369926    
Other Study ID Numbers: TLS-002
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Keywords provided by Transparency Life Sciences:
multiple sclerosis
telemedicine
remote monitoring
lisinopril
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases