Multiple Sclerosis, Relapsing-RemittingPhase 2NCT02369926
Endpoint Calibration for a Phase 2 Study of Lisinopril in Multiple Sclerosis
A Phase 2 study testing Multiple Sclerosis Functional Composite and Mobile Multiple Sclerosis Functional Composite in people with Multiple Sclerosis, Relapsing-Remitting, run by Transparency Life Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Multiple Sclerosis Functional Composite and Mobile Multiple Sclerosis Functional Composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ruthie Perez contact
Tarah Gustafson contact
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Tarah Gustafson, tarah.gustafson@mssm.edu
Fred Lublin, MD
About this study
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
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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Multiple Sclerosis Functional Composite, Mobile Multiple Sclerosis Functional Composite
- Keywords
- multiple sclerosis, telemedicine, remote monitoring, lisinopril
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Sclerosis Functional CompositeProcedure or surgery
Also called MSFC
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.
Mobile Multiple Sclerosis Functional CompositeProcedure or surgery
Also called mMSFC
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 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. Receives: Procedure: Multiple Sclerosis Functional Composite; Procedure: Mobile Multiple Sclerosis Functional Composite |
| Group 2 | Active comparator | 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. Receives: Procedure: Multiple Sclerosis Functional Composite; Procedure: Mobile Multiple Sclerosis Functional Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 6
MSFC Score Comparison
mMSFC scores will be compared to MSFC scores for proof of calibration.
Measured: 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.
Measured: Week 6
Mobile 9-hole Peg Test Time Comparison
Mobile 9HPT time will be compared to 9 HPT time for proof of calibration.
Measured: Week 6
Mobile Paced Auditory Serial Addition Test Score Comparison
Mobile PASAT3 scores will be compared to PASAT3 scores for proof of calibration.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transparency Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomasz Sablinski, MD, PhD, Study director, Transparency Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369926
- Sponsor's protocol ID
- TLS-002
- Status last verified
- Oct 2017
- First submitted
- 10 Feb 2015
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02369926
- Acronym / sponsor ID
- TLS-002
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- multiple sclerosis, telemedicine, remote monitoring, lisinopril
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Transparency Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jun 2018 (estimated)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Multiple Sclerosis Functional Composite, Procedure: Mobile Multiple Sclerosis Functional CompositeParticipants 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 comparator | Procedure: Multiple Sclerosis Functional Composite, Procedure: Mobile Multiple Sclerosis Functional CompositeParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Sclerosis Functional CompositeAlso: MSFCThe 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. | Procedure or surgery | Group 1, Group 2 |
| Mobile Multiple Sclerosis Functional CompositeAlso: mMSFCThe 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. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruthie Perez contact
Tarah Gustafson contact
Tomasz Sablinski, MD, PhD study director
Transparency Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multiple Sclerosis Functional Composite and Mobile Multiple Sclerosis Functional Composite in people with Multiple Sclerosis, Relapsing-Remitting, run by Transparency Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruthie Perez (ruthie.perez@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of mMSFC Tally (time frame: Week 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.