Status:
COMPLETED
Study of ALS Reversals 2: Genetic Analyses
Lead Sponsor:
Duke University
Collaborating Sponsors:
CReATe Consortium (funded by NIH/NCATS/NINDS)
Conditions:
Amyotrophic Lateral Sclerosis
Progressive Muscular Atrophy
Eligibility:
All Genders
Brief Summary
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 rev...
Detailed Description
Amyotrophic Lateral Sclerosis (ALS) is a devastating motor neuron disease that typically causes rapidly progressive muscle weakness, disability and premature death. In spite of a large number of attem...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03464903
Start Date
June 22 2018
End Date
December 1 2023
Last Update
January 11 2024
Active Locations (1)
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1
Duke ALS Clinic / DUSOM Dept of Neurology / DUHS
Durham, North Carolina, United States, 27705