Rehabilitation in SOD1 ALS Treated With Tofersen

NCT ID: NCT05725759

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-08

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis Lou Gehrig Disease Familial Amyotrophic Lateral Sclerosis Motor Neuron Disease Motor Neuron Disease, Familial

Study Groups

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Rehabilitation Arm

Participants will participate in outpatient physical and/or occupational therapies while participating in the tofersen early access program (EAP)

Rehabilitation

Intervention Type BEHAVIORAL

Particapants currently receiving tofersen treatment will be referred to outpatient physical and/or occupational therapy.

Interventions

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Rehabilitation

Particapants currently receiving tofersen treatment will be referred to outpatient physical and/or occupational therapy.

Intervention Type BEHAVIORAL

Other Intervention Names

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physical therapy occupational therapy

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of ALS with an SOD1 mutation
* Current enrollment in the tofersen expanded access program
* Age greater than 18 years
* Medically able to participate in outpatient physical therapy and/or home-based rehabilitation, as determined by the treating health care provider

Exclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sean E Smith

Instructor in Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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https://alscenter.wustl.edu

Washington University ALS Center website

Other Identifiers

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202208170

Identifier Type: -

Identifier Source: org_study_id

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