12000 Participants Needed

Biorepository Project for Leukodystrophy

(MDBP Trial)

Recruiting at 25 trial locations
OS
CB
Overseen ByConstance Besnier
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather and study data and samples from individuals with leukodystrophy, a rare disorder affecting the brain's white matter. Researchers hope to identify new genetic causes, develop diagnostic tools, and improve future treatments. Individuals with a confirmed or suspected diagnosis of leukodystrophy, supported by brain imaging, may be suitable for participation. The trial also welcomes healthy individuals, such as caregivers, who do not have the disorder. As an unphased trial, participants can contribute to groundbreaking research that may enhance the understanding and treatment of leukodystrophy.

Why are researchers excited about this trial?

The Myelin Disorders Biorepository Project is unique because it focuses on collecting and analyzing biological samples from patients with myelin disorders to better understand these conditions. Unlike current treatments that primarily aim to manage symptoms, this project seeks to uncover the underlying mechanisms and potential biomarkers of myelin disorders, which could lead to more effective and targeted therapies in the future. Researchers are excited because this comprehensive data collection and analysis could pave the way for breakthroughs in diagnosing and treating myelin disorders, potentially transforming the standard of care for patients.

Who Is on the Research Team?

AV

Adeline Vanderver, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

Inclusion Criteria

Male or female of any age;
Suspected or confirmed diagnosis of leukodystrophy or other disorder affecting the white matter of the brain based primarily on the finding of central nervous system neuroimaging consistent with this diagnosis or on an existing diagnosis of a leukodystrophy or genetic leukoencephalopathy as defined in existing classification systems;
Documentation of informed consent by the subject, parent, or legal guardian, and, if appropriate, documentation of assent;
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection and Biorepository Development

Collection and analysis of clinical data and biological samples from leukodystrophy patients to support research projects

10 years

Next-Generation Sequencing Assessment

Assess the utility and validity of next-generation sequencing in the diagnosis of leukodystrophies

10 years

Follow-up

Participants are monitored for changes in care, clinical state, and natural history of leukodystrophy

10 years

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

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749
Recruited
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Ionis Pharmaceuticals, Inc.

Industry Sponsor

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Recruited
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Dr. Brett P. Monia profile image

Dr. Brett P. Monia

Ionis Pharmaceuticals, Inc.

Chief Executive Officer since 2020

PhD in Pharmacology from the University of Pennsylvania, BSc in Molecular Biology and Analytical Chemistry from Stockton State College

Dr. Eric Bastings profile image

Dr. Eric Bastings

Ionis Pharmaceuticals, Inc.

Chief Medical Officer

MD

Sana Biotechnology

Industry Sponsor

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United MSD Foundation

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Don't Forget Me Foundation

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Pennsylvania Department of Health

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PMD Foundation

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Takeda Pharmaceutical Co. Limited

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