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Last Updated: November 16, 2024

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CLINICAL TRIALS PROFILE FOR SPINRAZA

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All Clinical Trials for SPINRAZA

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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.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for SPINRAZA

Condition Name

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

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Condition MeSH for SPINRAZA
Intervention	Trials
Muscular Atrophy	12
Atrophy	12
Muscular Atrophy, Spinal	12
[disabled in preview]	0
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Clinical Trial Locations for SPINRAZA

Trials by Country

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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

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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

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Clinical Trial Phase for SPINRAZA
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2	3
[disabled in preview]	1
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Clinical Trial Status

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Clinical Trial Status for SPINRAZA
Clinical Trial Phase	Trials
Completed	4
Active, not recruiting	2
Terminated	2
[disabled in preview]	1
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Clinical Trial Sponsors for SPINRAZA

Sponsor Name

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Sponsor Name for SPINRAZA
Sponsor	Trials
Biogen	11
Ionis Pharmaceuticals, Inc.	8
Winthrop University Hospital	1
[disabled in preview]	1
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Sponsor Type

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Sponsor Type for SPINRAZA
Sponsor	Trials
Industry	19
Other	2
[disabled in preview]	0
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