Pre-Symptomatic Study of Intravenous Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy (SMA) for Patients With Multiple Copies of SMN2 (SPR1NT)
A Global Study of a Single, One-Time Dose of AVXS-101 Delivered to Infants With Genetically Diagnosed and Pre-symptomatic Spinal Muscular Atrophy With Multiple Copies of SMN2
Sponsor: Novartis Gene Therapies
A PHASE3 clinical study on Spinal Muscular Atrophy, this trial is completed. The trial is conducted by Novartis Gene Therapies and has accumulated 28 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
28 versions recorded-
Feb 2026 — Present [monthly]
Completed PHASE3
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Sep 2025 — Feb 2026 [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jan 2023 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 23 earlier versions
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Dec 2022 — Jan 2023 [monthly]
Completed PHASE3
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Sep 2022 — Dec 2022 [monthly]
Completed PHASE3
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Feb 2022 — Sep 2022 [monthly]
Completed PHASE3
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Sep 2021 — Feb 2022 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Apr 2021 — Sep 2021 [monthly]
Active Not Recruiting PHASE3
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Jan 2021 — Apr 2021 [monthly]
Active Not Recruiting PHASE3
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Dec 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE3
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Nov 2020 — Dec 2020 [monthly]
Active Not Recruiting PHASE3
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Jun 2020 — Nov 2020 [monthly]
Active Not Recruiting PHASE3
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Feb 2020 — Jun 2020 [monthly]
Active Not Recruiting PHASE3
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Dec 2019 — Feb 2020 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Sep 2019 — Dec 2019 [monthly]
Recruiting PHASE3
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Jun 2019 — Sep 2019 [monthly]
Recruiting PHASE3
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May 2019 — Jun 2019 [monthly]
Recruiting PHASE3
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Mar 2019 — May 2019 [monthly]
Recruiting PHASE3
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Jan 2019 — Mar 2019 [monthly]
Recruiting PHASE3
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Dec 2018 — Jan 2019 [monthly]
Recruiting PHASE3
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Nov 2018 — Dec 2018 [monthly]
Recruiting PHASE3
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Oct 2018 — Nov 2018 [monthly]
Recruiting PHASE3
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Sep 2018 — Oct 2018 [monthly]
Recruiting PHASE3
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Aug 2018 — Sep 2018 [monthly]
Recruiting PHASE3
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Jun 2018 — Aug 2018 [monthly]
Recruiting PHASE3
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May 2018 — Jun 2018 [monthly]
Recruiting PHASE3
First recorded
Apr 2018
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Novartis Gene Therapies
- PRA Health Sciences
For direct contact, visit the study record on ClinicalTrials.gov .