Multiple SclerosisNCT05503524
Finding Patterns In Clinical Study Experiences of Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Power Life Sciences Inc..
Trial summary
Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple Sclerosis patients who are actively considering involvement in an interventional clinical trial, but have not yet completed enrollment and registration.
Who may be able to join
- Participant has a diagnosis of Multiple Sclerosis
- Patient has self-identified as planning to enroll in an interventional clinical trial for Multiple Sclerosis
- Patient is at least 18 years of age
Who cannot join
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
- No diagnosis of Multiple Sclerosis confirmed
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Extensive Clinical Trial Experiences of Multiple Sclerosis Patients To Determine Trial Attributes Affecting Completion Rates For Specific Demographic Groups
Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This study will admit a wide range of data on the clinical trial experience of Multiple Sclerosis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Multiple Sclerosis patients.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Sclerosis
- Medical subject headings
- Multiple Sclerosis, Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a Multiple Sclerosis Clinical Trial
Measured: 3 months
Number of patients who remain in Multiple Sclerosis clinical trial until completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503524
- Sponsor's protocol ID
- 98852353
- Status last verified
- Dec 2023
- First submitted
- 12 Aug 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He A, Merkel B, Brown JWL, Zhovits Ryerson L, Kister I, Malpas CB, Sharmin S, Horakova D, Kubala Havrdova E, Spelman T, Izquierdo G, Eichau S, Trojano M, Lugaresi A, Hupperts R, Sola P, Ferraro D, Lycke J, Grand'Maison F, Prat A, Girard M, Duquette P, Larochelle C, Svenningsson A, Petersen T, Grammond P, Granella F, Van Pesch V, Bergamaschi R, McGuigan C, Coles A, Hillert J, Piehl F, Butzkueven H, Kalincik T; MSBase study group. Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study. Lancet Neurol. 2020 Apr;19(4):307-316. doi: 10.1016/S1474-4422(20)30067-3. Epub 2020 Mar 18.
PubMed 32199096Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.
PubMed 24871874Belbasis L, Bellou V, Evangelou E, Ioannidis JP, Tzoulaki I. Environmental risk factors and multiple sclerosis: an umbrella review of systematic reviews and meta-analyses. Lancet Neurol. 2015 Mar;14(3):263-73. doi: 10.1016/S1474-4422(14)70267-4. Epub 2015 Feb 4.
PubMed 25662901
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extensive Clinical Trial Experiences of Multiple Sclerosis Patients To Determine Trial Attributes Affecting Completion Rates For Specific Demographic Groups
- ClinicalTrials.gov ID
- NCT05503524
- Acronym / sponsor ID
- 98852353
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Aug 2022 (actual)
- 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.
Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This study will admit a wide range of data on the clinical trial experience of Multiple Sclerosis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Multiple Sclerosis patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Sclerosis patients who are actively considering involvement in an interventional clinical trial, but have not yet completed enrollment and registration.
Key inclusion criteria (3 listed)
- Participant has a diagnosis of Multiple Sclerosis
- Patient has self-identified as planning to enroll in an interventional clinical trial for Multiple Sclerosis
- Patient is at least 18 years of age
Key exclusion criteria (3 listed)
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
- No diagnosis of Multiple Sclerosis confirmed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of patients who decide to enroll in a Multiple Sclerosis Clinical Trial
Time frame: 3 months
Number of patients who remain in Multiple Sclerosis clinical trial until completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Background: PubMed 32199096He A, Merkel B, Brown JWL, Zhovits Ryerson L, Kister I, Malpas CB, Sharmin S, Horakova D, Kubala Havrdova E, Spelman T, Izquierdo G, Eichau S, Trojano M, Lugaresi A, Hupperts R, Sola P, Ferraro D, Lycke J, Grand'Maison F, Prat A, Girard M, Duquette P, Larochelle C, Svenningsson A, Petersen T, Grammond P, Granella F, Van Pesch V, Bergamaschi R, McGuigan C, Coles A, Hillert J, Piehl F, Butzkueven H, Kalincik T; MSBase study group. Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study. Lancet Neurol. 2020 Apr;19(4):307-316. doi: 10.1016/S1474-4422(20)30067-3. Epub 2020 Mar 18.
- Background: PubMed 24871874Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.
- Background: PubMed 25662901Belbasis L, Bellou V, Evangelou E, Ioannidis JP, Tzoulaki I. Environmental risk factors and multiple sclerosis: an umbrella review of systematic reviews and meta-analyses. Lancet Neurol. 2015 Mar;14(3):263-73. doi: 10.1016/S1474-4422(14)70267-4. Epub 2015 Feb 4.
- Individual participant dataSharing planned: Undecided
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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.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Power Life Sciences Inc..
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 3 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Michael B Gill (415-900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to enroll in a Multiple Sclerosis Clinical Trial (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503524, which also lists 3 linked publications.
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 2 Jan 2024.