Spinal Muscular Atrophy Trial, Recruiting NCT04174157 Sponsor: Novartis Pharmaceuticals Condition: Spinal Muscular Atrophy
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Spinal Muscular Atrophy Trial, Recruiting

NCT04174157
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been treated with a gene therapy called OAV-101 (also known as Zolgensma) and have been diagnosed with Spinal Muscular Atrophy (SMA) confirmed by genetic testing, no matter when you were diagnosed.
  • You (or your parent/guardian, if applicable) have agreed and given permission to take part in this registry.

Who may not be able to join:

  • You are currently taking part in another clinical trial that is testing an investigational (not yet fully approved) medicine for SMA.

Important notes about eligibility:

  • If you received OAV-101 (Zolgensma) through a special access or compassionate use program — such as a Managed Access Program, Expanded Access Program, Single Patient program, or Named Patient Program — you may still be eligible to join this registry, regardless of when your SMA was diagnosed (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Phone: 1-888-669-6682

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
25 September 2018
Est. completion
30 June 2038

Where this trial is recruiting

🇬🇷 Greece 🇮🇪 Ireland 🇮🇱 Israel 🇯🇵 Japan 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇰🇷 South Korea 🇹🇼 Taiwan 🇺🇸 United States

Primary endpoints

Change in probability of survival of all patients with SMA using Kaplan Meier method to estimate; Change from baseline Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) in infants with pre-symptomatic or type I SMA; Change from baseline Hammersmith Infant Neurological Examination (HINE) in infants with pre-symptomatic, type I or type II SMA; Change from baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) for patients with type II and III SMA; Incidence of treatment emergent adverse events; Incidence of treatment emergent serious adverse events...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov