Authorised Therapeutic confirmatory (Phase III) Spinal Muscular Atrophy

Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen (ONWARD)

EU CTIS ID: 2023-505637-27-00

What this study is testing

The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566).

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the study protocol

You likely can't join if

  • Treatment with another investigational therapy or enrollment in another interventional clinical study
  • Treatment with an approved therapy for SMA after the Day 302 Visit of Study 232SM203 (NCT04089566). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

The study team makes the final eligibility decision.

Where it's taking place

  • Chile
  • Canada
  • Taiwan
  • Colombia
  • Japan
  • Mexico
  • Russian Federation
  • United States
  • Saudi Arabia
  • Brazil
  • China
  • Lebanon

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chile; Canada; Taiwan; Colombia; Japan; Mexico and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.