Trial · NCT02451696
A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD
NCT02451696, Phase 2, Completed, NYU Langone Health; results first posted 2021-09-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD. Trials, record NCT02451696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02451696
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD
- NCT number
- NCT02451696
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Epilepsy, Tuberous Sclerosis Complex, Focal Cortical Dysplasia
- Interventions
- Everolimus
- First posted
- 2015-05-22
- Last updated
- 2021-09-01
- Results first posted
- 2021-09-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Adverse Events | 6 weeks | .Adverse event monitoring should be continued for at least 30 days (or 5 half-lives, whichever is longer) following the last dose of study treatment |
| Secondary | Blood Everolimus Levels | 28 days | mTOR signaling in blood |
| Secondary | Blood Total VEGF Levels (Not Only VEGF-D) | 28 days | |
| Secondary | mTOR Brain Tissue-S6 Phosphate by Western Blot | 28 days | |
| Secondary | HMGB1 Expression in Brain Tissue | 28 days | HMGB1 expression is measured through label-free quantification (LFQ). LFQ is a method in mass spectroscopy that determines the relative amount of proteins in biological samples. The unit of measure is LFQ intensity; a higher LFQ intensity indicates greater HMGB1 expression. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Adverse Events | 6 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Blood Everolimus Levels | 28 days | ng/ml | MEAN | |
| SECONDARY | Blood Total VEGF Levels (Not Only VEGF-D) | 28 days | pg/ml | MEAN | |
| SECONDARY | mTOR Brain Tissue-S6 Phosphate by Western Blot | 28 days | normalized val-protein relative to actin | MEAN | |
| SECONDARY | HMGB1 Expression in Brain Tissue | 28 days | LFQ intensity | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Adverse Events | Treated Subjects | 0 | Participants | ||
| Number of Patients With Adverse Events | Reference Subjects | 0 | Participants | ||
| Blood Everolimus Levels | Treated Subjects | 12.35 | Standard Deviation 5.36 | ng/ml | |
| Blood Everolimus Levels | Reference Subjects | 2 | Standard Deviation 0 | ng/ml | |
| Blood Total VEGF Levels (Not Only VEGF-D) | Treated Subjects | 56.5 | Standard Deviation 46.9 | pg/ml | |
| Blood Total VEGF Levels (Not Only VEGF-D) | Reference Subjects | 50.85 | Standard Deviation 54.1 | pg/ml | |
| mTOR Brain Tissue-S6 Phosphate by Western Blot | Treated Subjects | 0.49 | Standard Deviation 0.54 | normalized val-protein relative to actin | |
| mTOR Brain Tissue-S6 Phosphate by Western Blot | Reference Subjects | 0.81 | Standard Deviation 0.22 | normalized val-protein relative to actin | |
| HMGB1 Expression in Brain Tissue | Treated Subjects | 14.85 | Standard Deviation 0.6 | LFQ intensity | |
| HMGB1 Expression in Brain Tissue | Reference Subjects | 15.06 | Standard Deviation 0.35 | LFQ intensity |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treated Subjects | 5 | |
| Overall Study | STARTED | Reference Subjects | 10 | |
| Overall Study | COMPLETED | Treated Subjects | 4 | |
| Overall Study | COMPLETED | Reference Subjects | 10 | |
| Overall Study | NOT COMPLETED | Treated Subjects | 1 | |
| Overall Study | NOT COMPLETED | Reference Subjects | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treated Subject | 0 | 4 |
| Total, all-cause mortality | Reference Subject | 0 | 10 |
| Total, other adverse events | Treated Subject | 0 | 4 |
| Total, other adverse events | Reference Subject | 0 | 10 |
| Total, serious adverse events | Treated Subject | 0 | 4 |
| Total, serious adverse events | Reference Subject | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35587487 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treated Subjects vs Reference Subjects: Number of Patients With Adverse Events | Trial comparisons |
| Treated Subject vs Reference Subject: deaths from any cause | Trial comparisons |
| Treated Subject vs Reference Subject: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02451696
GET https://conductscience.org/api/trials/v1/NCT02451696/registered