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Recruiting NCT06978985

Adult SMA Research and Clinical Hub

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Plain-language summary for patients

Trial Parameters

Condition Spinal Muscular Atrophy (SMA)
Sponsor Newcastle-upon-Tyne Hospitals NHS Trust
Study Type OBSERVATIONAL
Phase N/A
Enrollment 600
Sex ALL
Min Age 16 Years
Max Age N/A
Start Date 2022-07-29
Completion 2027-04-30
Interventions
RisdiplamNusinersen Injectable Product

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Brief Summary

Adult SMA REACH is a data collection study aiming to gain a better understanding of the impact of standards of care and new treatments on the natural history of Spinal Muscular Atrophy (SMA). This study is sponsored by The Newcastle upon Tyne Hospitals NHS Foundation Trust. Adult SMA REACH is funded by Biogen and Roche. Currently, there are three drug treatments available for SMA in the UK: Zolgensma, Nusinersen and Risdiplam. Zolgensma is the only approved drug - Nusinersen and Risdiplam are currently available as part of Managed Access Agreements (MAA).

Eligibility Criteria

Inclusion Criteria: * Age ≥16 years (when patients will begin the transition process to adulthood) * Genetically confirmed diagnosis of 5q SMA * Signed informed consent to take part in the study Exclusion Criteria: * Non-5q SMA * No genetic confirmation * \<16 years of age * No signed informed consent or consent withdrawn

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