Spinal Muscular Atrophy Trial, Recruiting (NCT05789758)

Spinal Muscular Atrophy Trial, Recruiting NCT05789758 Sponsor: Biogen Condition: Spinal Muscular Atrophy

Printed from Voxsanity (voxsanity.com.au) — NCT05789758 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Spinal Muscular Atrophy

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 are currently pregnant, or were pregnant during the relevant time period, and are already registered in one of these specific patient registries in the US, UK, Germany, Austria, or Switzerland
You have genetic test results confirming a diagnosis of spinal muscular atrophy (SMA) linked to a specific gene location called chromosome 5q
You received a medication called nusinersen either up to about 14 months before your last menstrual period before becoming pregnant, or at any point during your pregnancy

Who may not be able to join:

You received a different SMA medication called risdiplam at any time from the start of your last menstrual period, or in the two weeks before you became pregnant, or you are planning to take risdiplam at any point during your pregnancy

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: Medical Director, Biogen

Phone: 866-633-4636

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT05789758

Sponsor: Biogen

Phase: Not Applicable

Status: Recruiting

Condition: Spinal Muscular Atrophy

Trial contact: 866-633-4636

More information: https://clinicaltrials.gov/study/NCT05789758

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You are currently pregnant, or were pregnant during the relevant time period, and are already registered in one of these specific patient registries in the US, UK, Germany, Austria, or Switzerland
You have genetic test results confirming a diagnosis of spinal muscular atrophy (SMA) linked to a specific gene location called chromosome 5q
You received a medication called nusinersen either up to about 14 months before your last menstrual period before becoming pregnant, or at any point during your pregnancy

Who may not be able to join:

You received a different SMA medication called risdiplam at any time from the start of your last menstrual period, or in the two weeks before you became pregnant, or you are planning to take risdiplam at any point during your pregnancy

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Biogen

Registry

ClinicalTrials.gov

Start date

15 December 2023

Est. completion

31 October 2032

Where this trial is recruiting

🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Number of Pregnancy Terminations; Number of Spontaneous Abortions; Number of Fetal Deaths; Number of Live Births; Number of Neonatal, Perinatal, and Infant Deaths; Number of Major Congenital Malformations (MCMs); Number of Infants Small for Gestational Age Birth; Number of Ectopic and Molar Pregnancies; Number of Maternal Deaths; Number of Infants With Abnormal Postnatal Growth and Development and Neurobehavioral Impairment

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