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NCT02141503 · ClinicalTrials.gov registry record
Clinical Biomarkers in Alpha-mannosidosis
A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- 11
- Enrollment target
NCT02141503: Completed study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT02141503 is a clinical trial that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02141503 has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- 11 participants
- Enrollment target
Study Summary
Background: \- Alpha-mannosidosis is a rare inherited disorder. It causes problems in many organs and tissues of the body. It can occur in children and adults. Because there is no treatment for this disease, researchers want to find out more about it. Objective: \- To learn more about Alpha-mannosidosis. Eligibility: \- People ages 5-60 with Alpha-mannosidosis. Design: * Participants will be recruited from patient support organizations and medical genetics clinics. * Participants will have 3 study visits, about once a year. A final evaluation will be made after 3 years. * Participants will have a medical history and a physical exam. * Blood samples and a urine sample will be collected. * Cerebrospinal fluid will be collected. A small area of the lower back will be numbed with medicine. A thin needle will be inserted between the spine bones. About 2 tablespoons of spinal fluid will be removed. * Brain magnetic resonance spectroscopy (MRS) scans will be done at each visit. MRS uses a strong magnetic field and radio waves to take pictures of chemicals in the brain with a scanner. The participant will lie on a table that can slide in and out of the cylinder. While in the scanner the participant will hear loud knocking noises. They will get earplugs or earmuffs to muffle the sound. Medicines might be used to keep the participant asleep during the MRS. * Participants will have a skin biopsy at the first visit only. A small area of the participant s skin will be numbed. A small circle of skin will be removed with a biopsy tool.
Primary Outcome
Identify cerebrospinal fluid biomarkers that could serve as candidate surrogate markers of treatment effect in a future clinical trial.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-07-24 |
| Est. Completion | 2019-11-29 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT02141503 record still lists
NCT02141503 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02141503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02141503 about?
NCT02141503 is a clinical study titled "Clinical Biomarkers in Alpha-mannosidosis". Background: \- Alpha-mannosidosis is a rare inherited disorder. It causes problems in many organs and tissues of the body. It can occur in children and adults. Because there is no treatment for this disease, researchers want to find out more about it. Objective: \- To learn more about Alpha-manno...
What is the current status of trial NCT02141503?
This trial is currently completed. The enrollment target is 11 participants. The study started on 2014-07-24. Estimated completion is 2019-11-29.
Who is sponsoring clinical trial NCT02141503?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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