Adults With SMA Treated With Nusinersen

NCT04591678 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2021-09-22

No results posted yet for this study

Summary

This is a single center, 22-month observational study of nusinersen treatment in adult patients with spinal muscular atrophy (SMA). There will be a total of seven visits. Nusinersen is provided as standard of care and not considered research in this study. Information will be collected regarding the general health, and function including muscle strength of, as well as any positive and/or adverse events experienced by the study participants.

Conditions

Interventions

DRUG

nusinersen

SPINRAZA (nusinersen) is FDA approved to treat spinal muscular atrophy (SMA) through intrathecal injection.

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY
  • Cure SMA

    collaborator OTHER
  • Ohio State University

    lead OTHER

Principal Investigators

  • Bakri Elsheikh, MD · Ohio State University

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-05-14
Completion
2021-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04591678 on ClinicalTrials.gov