Phase 4 Motor Neurone Disease Trial, Recruiting NCT07223723 Sponsor: Biogen Condition: Motor Neurone Disease
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Phase 4 Motor Neurone Disease Trial, Recruiting

NCT07223723
Recruiting Phase 4

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:

  • People who are 18 years of age or older at the time of signing the consent form
  • People who have been diagnosed with SOD1-ALS (a specific genetic form of ALS caused by a mutation in the SOD1 gene)
  • People taking riluzole (an ALS medication) who have been on a stable dose for at least 30 days before the study starts, and who are expected to stay on that same dose throughout the study
  • People taking edaravone (another ALS medication) who have been on it for at least 60 days (two treatment cycles) before the study starts, and who are expected to stay on that same dose throughout the study
  • Women who could become pregnant must use effective birth control for the duration of the study

Who may not be able to join:

  • People who have had an allergic reaction to tofersen injection or any of its ingredients
  • People who have previously received or are currently receiving tofersen injection, whether through a commercial prescription or another clinical trial
  • People who have previously received or are currently receiving small interfering RNA therapy, stem cell therapy, or gene therapy
  • People who have taken another experimental drug, biological agent, or device within 1 month (or 5 half-lives of that agent, whichever is longer) before the baseline visit
  • People who are pregnant, currently breastfeeding, or planning to become pregnant during the study

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 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Registry
ClinicalTrials.gov
Start date
11 December 2025
Est. completion
16 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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: 26 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