NCT03464903Completed
Study of ALS Reversals 2: Genetic Analyses
ALS Reversals: Genetic Analyses (St.A.R. Protocol 2) RDCRN CReATe Protocol #8007
Source: ClinicalTrials.gov · Last updated 11 Jan 2024
Brief summary (registry, in English)
The purpose of this study is to try to understand why reversals of amyotrophic lateral sclerosis (ALS) and primary muscular atrophy (PMA) take place. The study will enroll patients with ALS or PMA reversals to give saliva samples in order to determine if the ALS or PMA reversal is because of certain changes in the genetic code.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 26 (actual)
- First submitted
- 8 Mar 2018
- Start date
- 22 Jun 2018
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Duke University
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT03464903
What you commit to
- Study type: Observational
- Participants enrolled: 26
- From 22 Jun 2018 to the primary completion date, 1 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior participation in the Phenotype Genotype and Biomarkers in ALS and Related Disorders (RDCRN #8001) protocol
Other illness
- History of cognitive impairment severe enough to preclude informed consent, reported by patient on direct questioning or as suspected by research personnel from Documentation of Known ALS Reversals (Duke IRB Pro00076395) study data
Who the study is looking for
- Prior participation in Documentation of Known ALS Reversals (Duke IRB Pro00076395)
- Confirmation of ALS or PMA (primary muscular atrophy) diagnosis through medical record review (previously documented in Documentation of Known ALS Reversals protocol)
- Sustained, robust improvement on at least one objective ALS outcomes measure (ex. ALSFRS-R, FVC, strength testing, EMG) (previously documented in Documentation of Known ALS Reversals protocol)
- Able to understand English
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke ALS Clinic / DUSOM Dept of Neurology / DUHS Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.