ALSNCT05423678
Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients
An observational study of ALS and Amyotrophic Lateral Sclerosis, run by Power Life Sciences Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS, Amyotrophic Lateral Sclerosis
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 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: Amyotrophic Lateral Sclerosis patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and registration.
Who may be able to join
- 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)
Who cannot join
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
- No diagnosis of Amyotrophic Lateral Sclerosis (ALS) confirmed
Trial locations and contacts
No sites are listed yet.
About this study
Official title: In Depth Observational Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients
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
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient decides to enroll in clinical trial
Measured: 3 months
Rate of patients who remain in clinical trial to trial 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 posted21 Jun 2022
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 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 ALSStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- 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
- NCT05423678
- Sponsor's protocol ID
- 12207799
- Status last verified
- Dec 2023
- First submitted
- 14 Jun 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21956723Sabatelli 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.
PubMed 23379621Powell 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.
PubMed 11152082
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
- In Depth Observational Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05423678
- Acronym / sponsor ID
- 12207799
- Conditions
- ALS, Amyotrophic Lateral Sclerosis
- Keywords
- als, als clinical trials, als diversity studies, amyotrophic lateral sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 Jun 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.
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.
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
- Amyotrophic Lateral Sclerosis patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and registration.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
- No diagnosis of Amyotrophic Lateral Sclerosis (ALS) 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
Number of patient decides to enroll in clinical trial
Time frame: 3 months
Rate of patients who remain in clinical trial to trial 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 21956723Chio 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.
- Background: PubMed 23379621Sabatelli 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.
- Background: PubMed 11152082Powell 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.
- 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 ALS and Amyotrophic Lateral 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 4 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, https://www.withpower.com/contact-us@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient decides to enroll in 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 NCT05423678, 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.