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Enrolling By Invitation
NCT05725759
Rehabilitation in SOD1 ALS Treated With Tofersen
Conditions: Amyotrophic Lateral Sclerosis, Lou Gehrig Disease, Familial Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Motor Neuron Disease, Familial
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 10
Sponsor: Washington University School of Medicine
Location: United States
Summary
The primary objective of this study is to document and describe the effects of a personalized rehabilitation program for patients with SOD1 ALS participating in the tofersen expanded access program.
Participants currently receiving tofersen treatment will be referred to outpatient physical and/or occupational therapy.
Participants will have an initial assessment performed and an individualized rehabilitation program will be prescribed.
Each participant is encouraged to follow the prescribed recommendations that will include scheduled outpatient therapy sessions, functional assessments, and/or a home-based rehabilitation program.
Functional assessments will be done at a minimum of every three months.
Eligibility Criteria
Inclusion Criteria:Confirmed diagnosis of ALS with an SOD1 mutationCurrent enrollment in the tofersen expanded access programAge greater than 18 yearsMedically able to participate in outpatient physical therapy and/or home-based rehabilitation, as determined by the treating health care providerExclusion Criteria:Any comorbidities or conditions that, in the opinion of the treating healthcare provider, would unacceptably increase the risk of participation in outpatient physical therapy and/or home-based rehabilitation
Source: ClinicalTrials.gov (NCT05725759). StuddyBuddy aggregates publicly available trial information.
