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Last Updated: December 5, 2021

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CLINICAL TRIALS PROFILE FOR SPINRAZA

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All Clinical Trials for Spinraza

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01494701 ↗ An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) Completed Biogen Phase 1 2011-11-30 This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA).
NCT01494701 ↗ An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) Completed Ionis Pharmaceuticals, Inc. Phase 1 2011-11-30 This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA).
NCT01703988 ↗ An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy Completed Biogen Phase 1/Phase 2 2012-10-31 This study will test the safety, tolerability, and pharmacokinetics of escalating doses of nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over the duration of the trial, in participants with spinal muscular atrophy (SMA). Four dose levels will be evaluated sequentially. Each dose level will be studied in a cohort of approximately 8 participants, where all participants will receive active drug.
NCT01703988 ↗ An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy Completed Ionis Pharmaceuticals, Inc. Phase 1/Phase 2 2012-10-31 This study will test the safety, tolerability, and pharmacokinetics of escalating doses of nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over the duration of the trial, in participants with spinal muscular atrophy (SMA). Four dose levels will be evaluated sequentially. Each dose level will be studied in a cohort of approximately 8 participants, where all participants will receive active drug.
NCT01839656 ↗ A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA) Completed Biogen Phase 2 2013-05-08 The primary objective is to examine the clinical efficacy of multiple doses of nusinersen (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular Atrophy (SMA). The secondary objectives are to examine the safety and tolerability of multiple doses of nusinersen administered intrathecally to participants with infantile-onset SMA and to examine the cerebral spinal fluid (CSF) and plasma Pharmacokinetics (PK) of multiple doses of nusinersen administered intrathecally to participants with infantile-onset SMA.
NCT01839656 ↗ A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA) Completed Ionis Pharmaceuticals, Inc. Phase 2 2013-05-08 The primary objective is to examine the clinical efficacy of multiple doses of nusinersen (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular Atrophy (SMA). The secondary objectives are to examine the safety and tolerability of multiple doses of nusinersen administered intrathecally to participants with infantile-onset SMA and to examine the cerebral spinal fluid (CSF) and plasma Pharmacokinetics (PK) of multiple doses of nusinersen administered intrathecally to participants with infantile-onset SMA.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Spinraza

Condition Name

Condition Name for Spinraza
Intervention Trials
Spinal Muscular Atrophy 10
Muscular Atrophy, Spinal 2
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Condition MeSH

Condition MeSH for Spinraza
Intervention Trials
Muscular Atrophy, Spinal 12
Muscular Atrophy 12
Atrophy 12
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Clinical Trial Locations for Spinraza

Trials by Country

Trials by Country for Spinraza
Location Trials
United States 70
Canada 8
Japan 7
Australia 6
Italy 5
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Trials by US State

Trials by US State for Spinraza
Location Trials
New York 8
California 7
Utah 7
Massachusetts 7
Texas 6
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Clinical Trial Progress for Spinraza

Clinical Trial Phase

Clinical Trial Phase for Spinraza
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Spinraza
Clinical Trial Phase Trials
Completed 4
Active, not recruiting 2
Terminated 2
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Clinical Trial Sponsors for Spinraza

Sponsor Name

Sponsor Name for Spinraza
Sponsor Trials
Biogen 11
Ionis Pharmaceuticals, Inc. 8
NYU Langone Health 1
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Sponsor Type

Sponsor Type for Spinraza
Sponsor Trials
Industry 19
Other 2
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Serving leading biopharmaceutical companies globally:

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