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NCT02386553 · ClinicalTrials.gov registry record · Phase 2

A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy

A Phase 2 study, sponsored by Biogen.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target

NCT02386553 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 25 participants.

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The verdict

NCT02386553, a Phase 2 study, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (SMA). Secondary objectives of this study are to examine the effects of Nusinersen in infants with genetically diagnosed and presymptomatic SMA.

Interventions

  • DRUG Nusinersen

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2015-05-18
Est. Completion 2024-12-17
Phase Phase 2

Sponsor

Biogen

334 total trials

What the Registry Record Tells You About NCT02386553

The ClinicalTrials.gov registry entry for NCT02386553 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Nusinersen is the first listed.

NCT02386553 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02386553 about?

NCT02386553 is a clinical study titled "A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy". The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (SMA). Secondary objectiv...

What is the current status of trial NCT02386553?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2015-05-18. Estimated completion is 2024-12-17.

What interventions are being tested in trial NCT02386553?

The interventions under investigation include: Nusinersen (DRUG).

Who is sponsoring clinical trial NCT02386553?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.