Gene therapy zolgensma tested in kids with SMA who stopped other drugs

NCT ID NCT05386680

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a one-time gene therapy called OAV101 (Zolgensma) in 27 children aged 2 to 18 with spinal muscular atrophy (SMA) who had previously stopped taking other SMA medications (Spinraza or Evrysdi). The goal was to see if the treatment is safe and can help maintain or improve muscle function. The therapy is given as a single injection into the spinal fluid.

What this could mean

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

Active substance

OAV101 (Zolgensma), a gene therapy given as a one-time spinal injection

What this could lead to

If successful, this could offer a one-time gene therapy option for children with SMA who have stopped other treatments, potentially stabilizing or improving motor function.

What could go wrong

This is a small, single-arm study (27 participants) with no comparison group, so results may not be generalizable. Risks include liver toxicity, low platelets, and other serious side effects.

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.

Kennedy disease muscle tissue disorder muscular atrophy spinal muscular atrophy

As listed by the trial registrant

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

Contacts and locations

Locations

  • Boston Childrens Hospital

    Boston, Massachusetts, 02215, United States

  • Child Hosp Of The Kings Daughters

    Norfolk, Virginia, 23507, United States

  • Novartis Investigative Site

    Parkville, Victoria, 3052, Australia

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    Bron, 69677, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011, Japan

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 162 8666, Japan

  • Novartis Investigative Site

    Utrecht, 3584, Netherlands

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035, Spain

  • University of Wisconsin Madison Medical School

    Madison, Wisconsin, 53792-7375, United States