Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients

NCT05423678 | Not Yet Recruiting

• 1 other identifier: 12207799
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical trial participation has always been substantially skewed toward certain demographic groups. However, there has been little study on whether trial qualities impact participation in either a positive or negative way. The goal of this research is to identify the characteristics that consistently restrict patients' ability to participate in or complete a trial in which they were initially interested. This data will be analyzed via a number of demographic lenses in order to find trends that could benefit future ALS sufferers.

Conditions

ALS; Amyotrophic Lateral Sclerosis

Keywords

als; als clinical trials; als diversity studies; amyotrophic lateral sclerosis

Outcome Measures

Primary Outcomes (2)

• Number of patient decides to enroll in clinical trial

  3 months

• Rate of patients who remain in clinical trial to trial 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

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

You may qualify if:

• Lives in the United States
• Is 18+ years old
• Participant has a diagnosis of Amyotrophic Lateral Sclerosis (ALS)
• Participant has enrolled in an interventional clinical for ALS (self-reported)

You may not qualify if:

• Inability to perform regular electronic reporting
• Patient does not understand, sign, and return consent form
• No diagnosis of Amyotrophic Lateral Sclerosis (ALS) confirmed

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• Chio A, Canosa A, Gallo S, Cammarosano S, Moglia C, Fuda G, Calvo A, Mora G; PARALS group. ALS clinical trials: do enrolled patients accurately represent the ALS population? Neurology. 2011 Oct 11;77(15):1432-7. doi: 10.1212/WNL.0b013e318232ab9b. Epub 2011 Sep 28.

  PMID: 21956723 BACKGROUND

• Sabatelli M, Conte A, Zollino M. Clinical and genetic heterogeneity of amyotrophic lateral sclerosis. Clin Genet. 2013 May;83(5):408-16. doi: 10.1111/cge.12117. Epub 2013 Mar 12.

  PMID: 23379621 BACKGROUND

• Powell JH, Fleming Y. Making medicines for America: the case for clinical trial diversity. J Natl Med Assoc. 2000 Nov;92(11):507-14. No abstract available.

  PMID: 11152082 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; https://www.withpower.com/contact-us@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: June 14, 2022
• First Posted: June 21, 2022
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12