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NCT07218575 · ClinicalTrials.gov registry record · Phase 2
Double-Blind Trial of Everolimus for Improving Social Abilities in PTEN Germline Mutations
A Phase 2 study, sponsored by Boston Children's Hospital.
- Not yet
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT07218575: Clinical Trial Phase 2 study, sponsored by Boston Children's Hospital.
NCT07218575 is a Phase 2 study that has not yet begun recruiting, run by Boston Children's Hospital. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07218575, a Phase 2 study, has not yet begun recruiting, sponsored by Boston Children's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The goal of this study is to examine the safety and treatment effects of everolimus in adults and children with PTEN Hamartoma Tumor Syndrome (PHTS) who experience social difficulties. The study will measure if everolimus can safely improve social abilities and functioning in this study population. PTEN Hamartoma Tumor Syndrome (PHTS) is a genetic condition that results from alteration (germline variant) to the PTEN gene. It is associated with a wide range of symptoms and characteristics, which vary from individual to individual. These include symptoms such as harmatomas (non-cancerous lesions), an increased risk of certain types of cancer, having a larger than average head, and abnormalities in blood vessels. Some people also have neurobehavioral problems including social difficulties. It is estimated approximately 25% (1 in 4) of people with PHTS meet the criteria for an autism diagnosis. The study lasts for one year. In the first 6 months half of participants will receive everolimus as a once daily oral tablet, and half will receive placebo tablets. For the second 6 months all participants will receive everolimus. Visits to the study clinic are required at the start, month 3, month 6, month 9 and month 12, with phone calls or virtual visits in between. Assessments include questionnaires, blood tests and urine tests, physical and neurological exams, and vital signs. Everolimus is an existing FDA approved medication used to treat other conditions, including a genetic condition called tuberous sclerosis complex which has some similarities to PHTS, and several types of cancer.
Primary Outcome
The SRS is a well-validated, reliable, and widely used measure for identifying and measuring impairments in social processing and associated behaviors. It is completed by an observer who knows the participant well (e.g. parent, care-giver, partner)
Interventions
- DRUG Placebo
- DRUG Everolimus blinded oral capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2030-09 |
| Phase | Phase 2 |
What is known before NCT07218575 opens enrollment
NCT07218575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07218575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07218575 about?
NCT07218575 is a clinical study titled "Double-Blind Trial of Everolimus for Improving Social Abilities in PTEN Germline Mutations". The goal of this study is to examine the safety and treatment effects of everolimus in adults and children with PTEN Hamartoma Tumor Syndrome (PHTS) who experience social difficulties. The study will measure if everolimus can safely improve social abilities and functioning in this study population. ...
What is the current status of trial NCT07218575?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-09-01. Estimated completion is 2030-09.
What interventions are being tested in trial NCT07218575?
The interventions under investigation include: Placebo (DRUG), Everolimus blinded oral capsules (DRUG).
Who is sponsoring clinical trial NCT07218575?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07218575's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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