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NCT04316546 · ClinicalTrials.gov registry record · Phase 2
MK-7075 (Miransertib) in Proteus Syndrome
A Phase 2 study of Proteus Syndrome, sponsored by National Human Genome Research Institute (NHGRI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04316546 is a Phase 2 study of Proteus Syndrome that is actively recruiting participants, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 45 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04316546, a Phase 2 study of Proteus Syndrome, is actively recruiting participants, sponsored by National Human Genome Research Institute (NHGRI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Proteus syndrome is a rare overgrowth disorder. Most people begin to have symptoms between 6 months and 2 years of age. There are very few living adults with this disease. There is also no known treatment for it. Researchers want to see if a new drug can slow down or stop overgrowth in people with Proteus syndrome. Objective: To learn if miransertib is a safe and effective treatment for Proteus syndrome. Eligibility: People ages 3 and older with Proteus syndrome. Design: Participants will be screened with a medical checkup. They will answer questions about their medical history and current health. They will have a physical exam with vital signs. They will have an electrocardiogram to measure their heartbeat. They will give blood and urine samples. They will repeat the screening tests during the study. Participants will take a miransertib pill once a day. They will bring their empty pill bottles with them to the NIH when they visit. If they can t swallow a pill, researchers will try to find other ways for them to take the drug. Participants will have X-rays, ultrasounds, and imaging scans. Photos may be taken of their feet and other parts of the body that have or develop signs of Proteus syndrome. Participants will have lung function tests to measure how much and how fast air moves out of their lungs. Participants will complete surveys about their levels of pain, physical functioning, and quality of life. Participants may have additional tests performed to assess their individual disease. They may have consultations with other specialists. Participation lasts about 4 years. Participants will have 20-30 visits at the NIH....
Conditions Studied
Interventions
- DRUG MK-7075 (miransertib)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-05-20 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04316546
The ClinicalTrials.gov registry entry for NCT04316546 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Human Genome Research Institute (NHGRI), which has 185 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Proteus Syndrome appearing as the primary indexed condition, and to 1 intervention - of which MK-7075 (miransertib) is the first listed.
NCT04316546 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04316546 about?
NCT04316546 is a clinical study titled "MK-7075 (Miransertib) in Proteus Syndrome". Background: Proteus syndrome is a rare overgrowth disorder. Most people begin to have symptoms between 6 months and 2 years of age. There are very few living adults with this disease. There is also no known treatment for it. Researchers want to see if a new drug can slow down or stop overgrowth in ...
What is the current status of trial NCT04316546?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2022-05-20. Estimated completion is 2028-07-01.
What conditions does trial NCT04316546 study?
This clinical trial studies the following conditions: Proteus Syndrome.
What interventions are being tested in trial NCT04316546?
The interventions under investigation include: MK-7075 (miransertib) (DRUG).
Who is sponsoring clinical trial NCT04316546?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04316546 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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