Finding Patterns In Clinical Study Experiences of Multiple Sclerosis Patients

NCT05503524 | Not Yet Recruiting

• 1 other identifier: 98852353
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a Multiple Sclerosis Clinical Trial

  3 months

• Number of patients who remain in Multiple Sclerosis clinical trial until completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multiple Sclerosis patients who are actively considering involvement in an interventional clinical trial, but have not yet completed enrollment and registration.

You may qualify if:

• 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

You may not qualify if:

• Inability to perform regular electronic reporting
• Patient does not understand, sign, and return consent form
• No diagnosis of Multiple Sclerosis confirmed

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 32199096 BACKGROUND

• Lublin 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.

  PMID: 24871874 BACKGROUND

• Belbasis 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.

  PMID: 25662901 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 16, 2022
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12