Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)

Last updated: July 5, 2024
Sponsor: Biogen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myasthenia Gravis (Chronic Weakness)

Muscular Dystrophy

Spinal Muscular Atrophy

Treatment

Nusinersen Sodium Injection

Clinical Study ID

NCT04317794
232SM403
  • All Genders

Study Summary

The primary objective is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in Korea. The secondary objective is to evaluate the effectiveness of nusinersen sodium injection in the postmarketing setting in Korea.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Currently receiving or about to initiate treatment with commercial Spinraza in thepostmarketing setting

  • Genetic documentation of 5q-linked SMA

Exclusion

Key Exclusion Criteria:

  • Hypersensitivity to the active substance or any of the excipients of Spinraza

  • Ongoing participation or participation within 6 months or 5 half-lives of the agent (whichever is longer) of enrollment in other interventional clinical trials for thetreatment of SMA

  • Inability to comply with study requirements

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 145
Treatment Group(s): 1
Primary Treatment: Nusinersen Sodium Injection
Phase:
Study Start date:
July 02, 2019
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • Pusan Natioanl University Hospital

    Busan,
    Korea, Republic of

    Completed

  • Samsung Changwon Hospital

    ChangWon,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si,
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Research site

    Jeonju, 54907
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeonju-si,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea university Anam Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Natioanl University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan,
    Korea, Republic of

    Active - Recruiting

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