NCT03624374 Natural History Study of Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation (LBSL)
| NCT ID | NCT03624374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
| Condition | Leukoencephalopathies |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-04-01 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2018-04-01 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, we will conduct retrospective chart and imaging reviews and prospective longitudinal virtual assessments of individuals with LBSL.
Eligibility Criteria
Inclusion Criteria: 1. Confirmed DARS2 mutation through genetic analysis 2. Ability of the caregiver or participant to speak and understand English at an 8th-grade level Exclusion Criteria: * The vulnerable populations of prisoners, non-viable neonates, pregnant women, adults lacking the capacity to consent, non-English speakers or children who are in foster care or wards of the state.
Contact & Investigator
Amena S Fine, MD PhD
PRINCIPAL INVESTIGATOR
Moser Center for Leukodystrophies at Kennedy Krieger Institute
Frequently Asked Questions
Who can join the NCT03624374 clinical trial?
This trial is open to participants of all sexes, studying Leukoencephalopathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03624374 currently recruiting?
Yes, NCT03624374 is actively recruiting participants. Contact the research team at makwana@kennedykrieger.org for enrollment information.
Where is the NCT03624374 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03624374 clinical trial?
NCT03624374 is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. The principal investigator is Amena S Fine, MD PhD at Moser Center for Leukodystrophies at Kennedy Krieger Institute. The trial plans to enroll 100 participants.