Endpoint Calibration for a Phase 2 Study of Lisinopril in Multiple Sclerosis
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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedOctober 12, 2017
October 1, 2017
3.6 years
February 10, 2015
October 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Week 6
MSFC Score Comparison
mMSFC scores will be compared to MSFC scores for proof of calibration.
Week 6
Mobile Timed Walk Test Value Comparison
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
Mobile 9HPT time will be compared to 9 HPT time for proof of calibration.
Week 6
Mobile Paced Auditory Serial Addition Test Score Comparison
Mobile PASAT3 scores will be compared to PASAT3 scores for proof of calibration.
Week 6
Study Arms (2)
Group 1
ACTIVE COMPARATORParticipants 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.
Group 2
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tomasz Sablinski, MD, PhD
Transparency Life Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 24, 2015
Study Start
November 1, 2014
Primary Completion
June 1, 2018
Last Updated
October 12, 2017
Record last verified: 2017-10