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Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05423678
Recruitment Status : Not yet recruiting
First Posted : June 21, 2022
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Power Life Sciences Inc.

Study Description
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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.

Condition or disease
ALS Amyotrophic Lateral Sclerosis

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: In Depth Observational Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients
Estimated Study Start Date : July 14, 2022
Estimated Primary Completion Date : July 14, 2023
Estimated Study Completion Date : July 14, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patient decides to enroll in clinical trial [ Time Frame: 3 months ]
  2. Rate of patients who remain in clinical trial to trial completion [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria

  • Inability to perform regular electronic reporting
  • Patient does not understand, sign, and return consent form
  • No diagnosis of Amyotrophic Lateral Sclerosis (ALS) confirmed
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05423678


Contacts
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Contact: Michael B Gill 415-900-4227 https://www.withpower.com/contact-us@withpower.com

Sponsors and Collaborators
Power Life Sciences Inc.
Investigators
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Study Director: Michael B Gill Power Life Sciences Inc.
  Study Documents (Full-Text)

Documents provided by Power Life Sciences Inc.:
Informed Consent Form  [PDF] June 14, 2022

More Information
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Publications:

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Responsible Party: Power Life Sciences Inc.
ClinicalTrials.gov Identifier: NCT05423678    
Other Study ID Numbers: 12207799
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Power Life Sciences Inc.:
als
als clinical trials
als diversity studies
amyotrophic lateral sclerosis
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases