A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy (EMBOLDEN)
A Global, Multicenter, Single-arm, Matched External Control Study of Intrathecal SHP611 in Subjects With Late Infantile Metachromatic Leukodystrophy
Sponsor: Shire
A observational or N/A phase clinical study on Metachromatic Leukodystrophy (MLD), this trial is ongoing. The trial is conducted by Shire and has accumulated 27 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
27 versions recorded-
Apr 16, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE2 → None
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Feb 2026 — Apr 2026 [monthly]
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Nov 2025 — Feb 2026 [monthly]
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Sep 2025 — Nov 2025 [monthly]
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Apr 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE2
▶ Show 22 earlier versions
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Sep 2024 — Apr 2025 [monthly]
Active Not Recruiting PHASE2
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
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Jul 2023 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
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Jan 2023 — Jul 2023 [monthly]
Active Not Recruiting PHASE2
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May 2022 — Jan 2023 [monthly]
Active Not Recruiting PHASE2
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Feb 2021 — May 2022 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Jan 2021 — Feb 2021 [monthly]
Recruiting PHASE2
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Nov 2020 — Jan 2021 [monthly]
Recruiting PHASE2
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Oct 2020 — Nov 2020 [monthly]
Recruiting PHASE2
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Jul 2020 — Oct 2020 [monthly]
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May 2020 — Jul 2020 [monthly]
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Mar 2020 — May 2020 [monthly]
Recruiting PHASE2
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Feb 2020 — Mar 2020 [monthly]
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Jan 2020 — Feb 2020 [monthly]
Recruiting PHASE2
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Nov 2019 — Jan 2020 [monthly]
Recruiting PHASE2
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Oct 2019 — Nov 2019 [monthly]
Recruiting PHASE2
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Sep 2019 — Oct 2019 [monthly]
Recruiting PHASE2
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Aug 2019 — Sep 2019 [monthly]
Recruiting PHASE2
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Jul 2019 — Aug 2019 [monthly]
Recruiting PHASE2
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Jun 2019 — Jul 2019 [monthly]
Recruiting PHASE2
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May 2019 — Jun 2019 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Jan 2019 — May 2019 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
The main aim of the study is to determine if SHP611 given by injection into the spinal fluid that surrounds the brain and spinal cord (intrathecal; IT) prolongs the time for children with Metachromatic Leukodystrophy (MLD) to retain the ability to move from place to place. Other aims of the study are to determine the effects of intrathecal administration of SHP611 on movement and speech functions and to learn how well SHP611 injected in the spinal fluid that surrounds the brain and spinal cord is tolerated. Study participants will receive SHP611 for about 2 years with the possibility of an extended treatment period.
Contact Information
- Shire
- Takeda Development Center Americas, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .