ClinicalTrials.gg
Not yet recruitingNCT07838779Updated Sep 24, 2026

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

An interventional study of Nusinersen Injectable Product in SMA - Spinal Muscular Atrophy, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Not yet recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies testing nusinersen in Muscular Atrophy, Spinal — 3 open to participants now, 4 under way, 2 of them phase 3. nusinersen · Muscular Atrophy, Spinal.

Planned enrollment
17th of 19
1 · median 34
Started
2026
with 1 other
No phase
2 of 19
1 open now
Registered
18th of 19
by date
Lead sponsor
2 of 19
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Among the 19 studies testing nusinersen in Muscular Atrophy, Spinal, this one is the 17th largest by planned enrollment, is one of 2 that started in 2026, is one of 2 with no phase, and was the 18th registered.

Muscular Atrophy, Spinal

282 studies on the registry are indexed under Muscular Atrophy, Spinal; 73 are open to participants now.

Browse Muscular Atrophy, Spinal studies →

Open to participants now

3 of the 19 studies testing nusinersen in Muscular Atrophy, Spinal are open now, in 8 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

About nusinersen

nusinersen: first FDA approval 2016 (SPINRAZA), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 58 Muscular Atrophy, Spinal studies recruiting now, 28 (48%) set no upper age limit and 27 (47%) stop at 75 or younger; 46 take children under 18; 11 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies testing nusinersen in Muscular Atrophy, Spinal, or all of them as a file.
02

Study summary

This study is an open label individual patient study of the drug Nusinsersen.

Read the detailed description

This is a Single Patient Study (SPS)/Open Label Individual Patient (OLIP) long-term extension study to evaluate the safety, tolerability, and efficacy of nusinersen administered by intrathecal injection at a higher dose (28 mg maintenance) for up to 5 years to a participant who has previously participated in Biogen Study 232SM302.

03

Conditions studied

  • SMA - Spinal Muscular Atrophy
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed of parent(s) or legal guardian(s) and signed informed assent of the participant, if indicated per participant's capacity to assent and institutional guidelines.
  2. Completion of Study 232SM302.
  3. Ability to complete all study procedures, measurements, and visits, and parent(s) or legal guardian(s)/participant has adequately supportive psychosocial circumstances, in the opinion of the Investigator.
  4. Meets age-appropriate institutional criteria for the use of anesthesia/sedation, if use is planned for study procedures (as assessed by the Investigator and either anesthesiologist or pulmonologist).
  5. All female participants of (defined as any female physiologically capable of becoming pregnant) and all male participants of reproductive age must practice effective .

Exclusion criteria

Exclusion Criteria:

  1. Any new condition or worsening of an existing condition that, according to the Investigator, would make the participant unsuitable for inclusion, could interfere with the assessment of safety, or would compromise the ability of the participant to undergo study procedures.
  2. Treatment with another therapy or enrollment in another interventional clinical study after the final dose in Study 232SM302.
  3. Treatment with an approved therapy for Spinal Muscular Atrophy after the final dose in Study 232SM302.
  4. History of systemic reaction to nusinersen, the contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study.
  5. Participants who are pregnant or currently breastfeeding and those intending to become pregnant during the study.
  6. The participant's parent(s) or legal guardian(s) is not willing or able to meet guidelines in the consensus statement for standard of care in Spinal Muscular Atrophy [Finkel 2018; Mercuri 2018] or provide nutritional and respiratory support throughout the study, per the Investigator's judgment.
  7. Other unspecified reasons that, in the opinion of the Investigator, make the participant unsuitable for enrollment.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (estimated)

Study arms

  • Experimental
    Open label

    Open label

    Drug: Nusinersen Injectable Product

Interventions

06

What researchers measure

Primary outcomes

  1. Long-term safety and tolerability of Nusinersen 28mg dosing through adverse events experienced

    The descriptors of adverse events experienced

    Time frame: From enrollment to the end of treatment of one year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — We have no plans to publish the data.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.

Of 48 non-industry interventional studies with no phase under Muscular Atrophy, Spinal, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 27 months is close to that.

Counting every sponsor, half of 57 studies reached it within 27 months; a quarter within 17 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 24, 2026
StartEst.
Sep 17, 2026
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07838779
Responsible party
Craig Campbell (Paediatric Neurologist, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Sep 24, 2026
Start date
Sep 17, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

Cara Grobbecker
Contact
cara.grobbecker@lhsc.on.ca
519-685-8500 ext. 56216

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Nusinersen

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