Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
In Depth Observational Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients
| NCT number | NCT05423678 |
| Other study ID # | 12207799 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2024 |
| Est. completion date | July 2026 |
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.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | July 2026 |
| Est. primary completion date | July 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patient decides to enroll in clinical trial | 3 months | ||
| Primary | Rate of patients who remain in clinical trial to trial completion | 12 months |
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