Study of ALS Reversals 2: Genetic Analyses

Completed

Conditions studied: Amyotrophic Lateral Sclerosis, Progressive Muscular Atrophy

In brief

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.

Key facts

Study ID

NCT03464903

Run by

Duke University

People needed

26

Starts

2018-06-22

Expected to finish

2023-12-01

Last updated by the study team

2024-01-11

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Prior participation in the Phenotype Genotype and Biomarkers in ALS and Related Disorders (RDCRN #8001) protocol

Where it is running

• Duke ALS Clinic / DUSOM Dept of Neurology / DUHS — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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