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NCT03771898 · ClinicalTrials.gov registry record · Phase 2
A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy
A Phase 2 study of Metachromatic Leukodystrophy (MLD), sponsored by Shire.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 20
- Study locations
NCT03771898 is a Phase 2 study of Metachromatic Leukodystrophy (MLD) that is active but no longer recruiting, run by Shire. The registered enrollment target is 36 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT03771898, a Phase 2 study of Metachromatic Leukodystrophy (MLD), is active but no longer recruiting, sponsored by Shire.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG SHP611
Study Locations (20)
Other
- UZ Antwerpen - Edegem
- Hospital de Clínicas de Porto Alegre - Porto Alegre
- Hôpital Bicêtre - Paris Sud - Le Kremlin-Bicêtre
- CHU Lenval - Nice
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
California
- Los Angeles Biomedical Research Institute at Harbor-UCLA - Torrance
Colorado
- Childrens Hospital Colorado - Aurora
Georgia
- Rare Disease Research, LLC - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Iowa
- University of Iowa Stead Family Children's Hospital - Iowa City
Minnesota
- Mayo Clinic - PPDS - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-05-13 |
| Est. Completion | 2026-03-16 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03771898
The ClinicalTrials.gov registry entry for NCT03771898 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metachromatic Leukodystrophy (MLD) appearing as the primary indexed condition, and to 1 intervention - of which SHP611 is the first listed.
NCT03771898 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT03771898 about?
NCT03771898 is a clinical study titled "A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy". 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 ar...
What is the current status of trial NCT03771898?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2019-05-13. Estimated completion is 2026-03-16.
What conditions does trial NCT03771898 study?
This clinical trial studies the following conditions: Metachromatic Leukodystrophy (MLD).
What interventions are being tested in trial NCT03771898?
The interventions under investigation include: SHP611 (DRUG).
Who is sponsoring clinical trial NCT03771898?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03771898 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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