Higher doses of SMA drug tested for Long-Term safety

NCT ID NCT04729907

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This long-term study is testing higher doses of nusinersen (Spinraza) in people with spinal muscular atrophy who already completed a previous nusinersen study. The main goal is to check safety over several years, including side effects, heart health, and growth. Participants receive the drug via lumbar puncture every 4 months for up to 64 months. The study involves 115 people and is not recruiting new participants.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

nusinersen (Spinraza)

What this could lead to

If this works, it could show that higher doses of nusinersen are safe and help maintain or improve motor function for people with spinal muscular atrophy over the long term.

What could go wrong

This is an extension study with no placebo group, so results may be less clear. Higher doses could also bring new side effects. The study is small (115 people) and focused on safety, not proof of effectiveness.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

spinal muscular atrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611-260, United States

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280, Mexico

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Medical Center

    Plano, Texas, 75024, United States

  • Clinica MEDS La Dehesa

    Santiago, 7691236, Chile

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 168, Italy

  • Fondazione Serena Onlus - Centro Clinico Nemo

    Milan, 20162, Italy

  • Guangzhou Woman and Children's Medical Center

    Guangzhou, Guangdong, 510623, China

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, Mexico City, 6720, Mexico

  • Hospital Sant Joan de Deu

    Esplugues Del Llobregat, Barcelona, 8950, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario San Ignacio

    Bogotá, 110231, Colombia

  • Hospital das Clinicas - FMUSP

    São Paulo, 5403900, Brazil

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Hyogo Medical University Hospital

    Nishinomiya-shi, Hyōgo, 663-8501, Japan

  • Instituto Nacional de Pediatria

    Mexico City, Mexico City, 4530, Mexico

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • King Fahad Specialist Hospital

    Dammam, 31444, Saudi Arabia

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 11211, Saudi Arabia

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011, Japan

  • London Health Sciences Centre (LHSC) - Children's Hospital

    London, Ontario, N6A 5W9, Canada

  • National Guard Health Affairs: King Abdulaziz Medical City

    Jeddah, 21423, Saudi Arabia

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Regional Pediatric Clinical Hospital #1

    Yekaterinburg, 620149, Russia

  • Russian Children Neuromuscular Center of Veltischev

    Moskva, 125412, Russia

  • Saint George University Hospital Medical Center

    Beirut, 11 00 2807, Lebanon

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • Stanford University Medical Center

    Sacramento, California, 94304, United States

  • Tallinn Children's Hospital

    Tallinn, 13419, Estonia

  • The Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052, China

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21205, United States

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo-To, 162-8666, Japan

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, Hesse, 35392, Germany