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A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy

This study tests Risdiplam's effects on kids with Spinal Muscular Atrophy.

Recruiting
3-24 years
All
Phase 4

Study Purpose: This study looks at how well a medicine called risdiplam works and how safe it is for young children with Spinal Muscular Atrophy (SMA). SMA is a genetic problem that makes muscles weak. The study focuses on kids under 2 years old who have already tried another treatment called onasemnogene abeparvovec but stopped improving or got worse.

Eligibility: To join, kids must be under 2 years old and have a confirmed diagnosis of SMA with 2 copies of a gene called SMN2. They must have had onasemnogene abeparvovec and shown decreased ability to do things like swallow or move.

  • Length: The study requires visits over several months to check progress.
  • Treatment: Participants will receive risdiplam, which is not tested on kids who had other similar treatments.
  • Risks: Eligibility excludes kids with certain health issues, like needing a feeding tube or recent hospital stays.

This study is conducted across multiple centers and does not have a placebo group, so all participants will receive the treatment. This is an open-label study, meaning both doctors and families know the treatment being given.

Study details
    Muscular Atrophy
    Spinal

NCT05861999

Hoffmann-La Roche

23 February 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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