Nusinersen for Spinal Muscular Atrophy

CG
Overseen ByCara Grobbecker
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

An Open Label Individual Patient (OLIP) Study of Nusinersen (BIIB058) in a Participant with Spinal Muscular Atrophy Who Previously Participated in an Investigational Study with Nusinersen

Who Is on the Research Team?

CC

Craig Campbell, MD, FRCPC

Principal Investigator

Children's Hospital, London Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for people with spinal muscular atrophy (SMA) who have already taken part in a previous study using Nusinersen. Participants must meet certain health requirements set by the researchers.

Inclusion Criteria

Completion of Study 232SM302
I am using effective birth control if I can have children.
My parent or guardian and I have signed the required consent forms.
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Exclusion Criteria

Other reasons making the participant unsuitable for enrollment, in the opinion of the Investigator
Any new condition or worsening of an existing condition that would make the participant unsuitable for inclusion, interfere with safety assessment, or compromise ability to undergo study procedures, according to the Investigator
Participants who are pregnant, currently breastfeeding, or intending to become pregnant during the study
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What Are the Treatments Tested in This Trial?

Interventions

  • Nusinersen

Trial Overview

The study is testing ongoing treatment with Nusinersen, an injectable medication designed to treat SMA. It follows individuals who previously received this drug in another clinical trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Open LabelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
678
Recruited
421,000+