A Phase 2/3 interventional study of Sirolimus in Sturge-Weber Syndrome, sponsored by Anne Comi, MD. Completed at 2 sites in United States. Open to participants aged 3 Years to 31 Years. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by Anne Comi, MD · Phase 2/3, Interventional, and Treatment
Among 1,418 studies in Cognitive Dysfunction with a site in United States — 328 open to participants now, 432 under way, 13 of them phase 3. Cognitive Dysfunction · United States.
Among the 1,418 studies in Cognitive Dysfunction with a site in United States, this one is the 1,036th largest by enrollment of the 1,143 interventional ones, is one of 76 that started in 2017, is one of 12 in phase 2/3, and was the 456th registered.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's enrollment of 10 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →328 of the 1,418 studies in Cognitive Dysfunction with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 3 Years to 31 Years · all sexes · no healthy volunteers.
The full table on the hub →1,418 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 76 started in 2017.
Median enrollment 58 across the 1,143 interventional studies, 150 across the 270 observational. Of the 885 that completed or were terminated, 377 (43%) have results posted.
209 of 1,418 have an industry lead sponsor. The 10 most frequent:
Anne Comi, MD is the lead sponsor of 3 studies on the registry; none are open to participants now.
Anne Comi, MD has 2 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
180 of the studies in Cognitive Dysfunction with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT06191965Phase 3Mclean HospitalMitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction | 2027-01-31 |
| NCT06950190Phase 3Ellis MedicineEvaluating Cognitive Changes on Patients in Chemotherapy (ECCPC) | 2027-02-20 |
| NCT03560960Boston UniversityMulti-Center Development of a Novel Diagnostic Test for Alzheimer's Disease | 2026-11 |
Among the 1,418 studies in Cognitive Dysfunction with a site in United States, from their registry updates:
The purpose of this research study is to gain a preliminary understanding of the safety of sirolimus in Sturge-Weber syndrome (SWS) and determine best outcomes to be used to assess the utility of sirolimus for the treatment of cognitive impairments related to Sturge-Weber syndrome.
Sirolimus will be administered as an adjunct to all current medications. The impact of sirolimus upon cognitive functioning in Sturge-Weber syndrome is the primary outcome measure. This outcome will be assessed using a panel of testing selected based upon extensive experience in testing cognitive function in adults and children with SWS at the Kennedy Krieger Sturge-Weber Center. Changes in a quantitative EEG before and after the trial, Sturge-Weber syndrome clinical neuroscore, port-wine birthmark score, and the impact of sirolimus upon seizures will be assessed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cognitive impairment as defined by the following:
SWS cognitive neuroscore of ≥ 1
Adequate liver function as shown by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will receive the sirolimus oral solution to be taken at home twice daily and will be treated on an outpatient basis. The drug will be taken for six months.
Drug: Sirolimus
Low dose oral sirolimus
Also known as: Rapamycin, Rapamune
Change in Cognitive Function as Assessed by the National Institute of Health (NIH) Toolbox Cognitive Battery
Change over six months in cognitive functioning in Sturge-Weber syndrome is the primary outcome measure. This outcome will be assessed using the NIH Toolbox Cognitive Battery, a panel of testing which includes the following measures: * the Flanker Inhibitory Control and Attention Test (executive function and attention) * the Dimensional Change Card Sort Test (executive function) * Picture Sequence Memory Test (episodic memory) * Oral Reasoning Recognition Test and Picture Vocabulary Test (language skills) * Pattern Comparison Processing Speed Test (processing speed) * List Sorting Working Memory Test (working memory) * 9-hole Peg Test (dexterity) * Grip Strength Test (grip strength) and * Patient-Reported Outcomes Measurement Information System (PROMIS) (self-report emotional functioning). These scores are rescaled to T scores (mean = 50, standard deviation (SD) = 10), referenced against the US population. Higher scores indicate better outcome. T scores only were analyzed.
Time frame: Baseline and at 6 months on the study drug
Difference in Mean Power Asymmetry of the Occipital Alpha Frequency Band
Change in mean laterality score (by qEEG power analysis) was done comparing hemispheres and occipital lobes in the following frequency bands; delta, theta, alpha, beta, as previously described. As post-hoc analysis, baseline and follow-up qEEG of patients with and without stroke-like episodes were compared. Greater asymmetry with decreased power on the affected side is worse. We calculated a mean Laterality Score (LSb) for each band, averaged over 30 epochs and included channel pairs. Laterality Scores less than zero indicate lower power on the side ipsilateral to the port wine birthmark. In subjects who had a bilateral port wine birthmark, the side of maximal involvement was used (or the side of known involvement by MRI findings, where present).
Time frame: Baseline and at 6months on the study drug
Change in Sturge-Weber Syndrome Clinical Neuroscore
Change in clinical neuroscore over the course of the study were measured. The neuroscore is comprised of frequency of seizures (0-4) , extent of hemiparesis (0-4), assessment of visual field cut (0-2) , and degree of cognitive functioning (0-5) with a minimum total score of 0 and a maximum total score of 15. Higher scores mean worsening of symptoms.
Time frame: Baseline and at 6 months on the study drug
Number of Participants With a Change in Sturge-Weber Syndrome Birthmark Score
Frontal and profile photograph will be taken under standardized conditions with scoring of the port-wine birthmark for percent of face covered, thickness of birthmark, and darkness of birthmark color.
Time frame: Visits at 2 weeks (baseline) and 28 weeks (study end)
| Milestone | Sirolimus |
|---|---|
| Started | 10 |
| Completed | 9 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Change over six months in cognitive functioning in Sturge-Weber syndrome is the primary outcome measure. This outcome will be assessed using the NIH Toolbox Cognitive Battery, a panel of testing which includes the following measures: * the Flanker Inhibitory Control and Attention Test (executive function and attention) * the Dimensional Change Card Sort Test (executive function) * Picture Sequence Memory Test (episodic memory) * Oral Reasoning Recognition Test and Picture Vocabulary Test (language skills) * Pattern Comparison Processing Speed Test (processing speed) * List Sorting Working Memory Test (working memory) * 9-hole Peg Test (dexterity) * Grip Strength Test (grip strength) and * Patient-Reported Outcomes Measurement Information System (PROMIS) (self-report emotional functioning). These scores are rescaled to T scores (mean = 50, standard deviation (SD) = 10), referenced against the US population. Higher scores indicate better outcome. T scores only were analyzed.
| T score | Sirolimus |
|---|---|
| National Institute of Health Toolbox Vocabulary Baseline | 44.2 ± 12.5 |
| National Institute of Health Toolbox Vocabulary Follow-up | 42.3 ± 12.3 |
| National Institute of Health Toolbox Attention Baseline | 34.1 ± 10.5 |
| National Institute of Health Toolbox Attention Follow-up | 35.2 ± 14.1 |
| National Institute of Health Toolbox Working Memory Baseline | 26.3 ± 9.8 |
| National Institute of Health Toolbox Working Memory Follow-up | 28.1 ± 3.9 |
| National Institute of Health Toolbox Executive Function Baseline | 33.1 ± 10.2 |
| National Institute of Health Toolbox Executive Function Follow-up | 35.7 ± 15.4 |
| National Institute of Health Processing Speed Baseline | 27.0 ± 14.5 |
| National Institute of Health Processing Speed Follow-up | 36.4 ± 17.6 |
| National Institute of Health Toolbox Sequential Memory Baseline | 39.3 ± 12.3 |
| National Institute of Health Toolbox Sequential Memory Follow-up | 40.9 ± 8.6 |
| National Institute of Health Toolbox Recognition Baseline | 37.7 ± 12.8 |
| National Institute of Health Toolbox Recognition Follow-up | 36.0 ± 10.4 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Baseline | 43.5 ± 8.3 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Follow-up | 35.4 ± 20.5 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Baseline | 45.9 ± 7.9 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Follow-up | 35.7 ± 20.4 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Baseline | 53.8 ± 5.1 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Follow-up | 36.7 ± 15.3 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference | 49.2 ± 11.1 |
| Patient-Reported Outcomes Measurement Information System Pain (PROMIS) Interference Follow-up | 36.1 ± 18.8 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Baseline | 46.9 ± 10.9 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Interference Follow-up | 41.9 ± 15.7 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relations Baseline | 49.8 ± 10.9 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relations Follow-up | 44.1 ± 17.5 |
| Grip Strength Dominant Baseline | 39.0 ± 14.4 |
| Grip Strength Dominant Follow-up | 42.0 ± 5.1 |
| Grip Strength Non-Dominant Baseline | 26.1 ± 28.2 |
| Grip Strength Non-Dominant Follow-up | 20.6 ± 28.9 |
| Dexterity Dominant Baseline | 30.6 ± 16.8 |
| Dexterity Dominant Follow-up | 31.6 ± 14.3 |
| Dexterity Non-Dominant Baseline | 31.6 ± 14.3 |
| Dexterity Non-Dominant Follow-up | 30.1 ± 19.9 |
Change in mean laterality score (by qEEG power analysis) was done comparing hemispheres and occipital lobes in the following frequency bands; delta, theta, alpha, beta, as previously described. As post-hoc analysis, baseline and follow-up qEEG of patients with and without stroke-like episodes were compared. Greater asymmetry with decreased power on the affected side is worse. We calculated a mean Laterality Score (LSb) for each band, averaged over 30 epochs and included channel pairs. Laterality Scores less than zero indicate lower power on the side ipsilateral to the port wine birthmark. In subjects who had a bilateral port wine birthmark, the side of maximal involvement was used (or the side of known involvement by MRI findings, where present).
| score on a scale | Sirolimus |
|---|---|
| Patients with Stroke-Like Episodes Baseline | 0.686 ± 0.03 |
| Patients with Stroke-Like Episodes Follow-up | 0.426 ± 0.19 |
| Patients without Stroke-like episodes Baseline | 0.167 ± 0.23 |
| Patients without stroke-line episodes follow-up | 0.247 ± 0.13 |
Change in clinical neuroscore over the course of the study were measured. The neuroscore is comprised of frequency of seizures (0-4) , extent of hemiparesis (0-4), assessment of visual field cut (0-2) , and degree of cognitive functioning (0-5) with a minimum total score of 0 and a maximum total score of 15. Higher scores mean worsening of symptoms.
| score on a scale | Sirolimus |
|---|---|
| Composite Score Baseline | 4.5 (0 to 15) |
| Composite Score Follow-up | 4.5 (0 to 15) |
| Seizure Score Baseline | 1 (0 to 4) |
| Seizure Score Follow-Up | 1 (0 to 4) |
| Hemiparesis Score Baseline | 1 (0 to 4) |
| Hemiparesis Score Follow-up | 1 (0 to 4) |
| Visual Field Cut Score Baseline | 0.5 (0 to 2) |
| Visual Field Cut Score Follow-up | 0 (0 to 2) |
| Cognitive Function Score Baseline | 2.5 (0 to 5) |
| Cognitive Function Score Follow-Up | 2.5 (0 to 5) |
Frontal and profile photograph will be taken under standardized conditions with scoring of the port-wine birthmark for percent of face covered, thickness of birthmark, and darkness of birthmark color.
| Participants | Sirolimus |
|---|---|
| Improved Port-Wine Score | 4 |
| No Change Port-Wine Score | 2 |
| Worsened Port-Wine Score | 2 |
| No Port-Wine Birthmark | 2 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sirolimus | 0/10 (0%) | 2/10 (20%) | 9/10 (90%) |
| Event | Sirolimus |
|---|---|
| HeadacheNervous system disorders | 1/10 |
| HeadacheNervous system disorders | 1/10 |
| AnemiaBlood and lymphatic system disorders | 1/10 |
| Event | Sirolimus |
|---|---|
| HypertriglyceridemiaMetabolism and nutrition disorders | 4/10 |
| Skin Ulceration in MouthSkin and subcutaneous tissue disorders | 3/10 |
| Increased aspartate aminotransferaseInvestigations | 2/10 |
| Decreased HDL CholesterolInvestigations | 2/10 |
| HeadacheNervous system disorders | 2/10 |
| Personality ChangeProduct Issues | 2/10 |
| Abdominal PainGastrointestinal disorders | 1/10 |
| NauseaGastrointestinal disorders | 1/10 |
| Upper Respiratory InfectionInfections and infestations | 1/10 |
| Increased Alanine AminotransferaseInvestigations | 1/10 |
| Age, Categorical(Participants) | Sirolimus |
|---|---|
| <=18 years | 9 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Age, Continuous(years) | Sirolimus |
|---|---|
| Mean | 12.58 ± 5.17 |
| Sex: Female, Male(Participants) | Sirolimus |
|---|---|
| Female | 5 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Sirolimus |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Sirolimus |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Sirolimus |
|---|---|
| United States | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jan 2017, a primary completion of Jun 2019 and a completion of Oct 2020. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2021, 2 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sirolimus