A Phase 2 interventional study of Everolimus in Sturge Weber Syndrome, sponsored by Baylor College of Medicine. Withdrawn at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-05-05.
Sponsored by Baylor College of Medicine · Phase 2, Interventional, and Treatment
Among 792 studies in Epilepsy with a site in United States — 164 open to participants now, 197 under way, 17 of them phase 3. Epilepsy · United States.
Among the 792 studies in Epilepsy with a site in United States, this one is the 563rd largest by enrollment of the 587 interventional ones, is one of 28 that started in 2014, is one of 103 in phase 2, and was the 322nd registered.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
Browse Epilepsy studies →164 of the 792 studies in Epilepsy with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 285 Epilepsy studies recruiting now, 113 (40%) set no upper age limit and 149 (52%) stop at 75 or younger; 139 take children under 18; 56 take healthy volunteers.
This study: 2 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →792 studies; the count open now beside each. This study's row is marked.
First in 1975; this study’s year is marked. 28 started in 2014.
Median enrollment 40 across the 587 interventional studies, 90 across the 193 observational. Of the 525 that completed or were terminated, 243 (46%) have results posted.
294 of 792 have an industry lead sponsor. The 10 most frequent:
Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Baylor College of Medicine has 5 studies filed under Epilepsy — fewer than ten, so there is no comparison to draw.
75 of the studies in Epilepsy with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06132893Phase 3Biohaven Therapeutics Ltd.A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | 2026-12 |
| NCT07010471Phase 3Praxis Precision MedicinesA Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine | 2026-12 |
| NCT07019922Phase 3Praxis Precision MedicinesA Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety | 2026-12 |
| NCT06660394Phase 3Longboard PharmaceuticalsA Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS) | 2026-12-31 |
| NCT05431595Phase 3M.D. Anderson Cancer CenterManaging Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy | 2027-02-02 |
Among the 792 studies in Epilepsy with a site in United States, from their registry updates:
Sturge Weber Syndrome (SWS) is a rare disease that affects the patient's brain and causes benign (non-cancerous) tumors to grow in the brain. One of the symptoms of SWS is epilepsy. People with epilepsy have seizures. Some patients may also have eye problems and a red mark on their facial skin.
This study is being done to find out if the study drug, everolimus, is safe and has helpful effects in patients with SWS who have seizures and are not responding to their current anti-epileptic medication.
The study drug, everolimus (Afinitor®), is supplied by Novartis Pharmaceuticals Corporation.
The main study part has 3 phases. The first phase is called the baseline phase and consists of 1-2 study site visit(s). During this phase, the investigators will gather information about the subject, his/her medical history, and current health.
During the second phase of the study, the subject will start taking the study drug. It will take approximately 4 weeks to find out the right amount of study drug the subject should be taking. This process is called the titration phase. There will be 2 visits during the titration phase.
Once the subject are on the right amount of study drug, he/she will take that dose for about 12 weeks. This phase is called the maintenance phase and consists of 3 study site visits.
At the end of the maintenance phase, if the study doctor determines that taking everolimus has helped to reduce the number of seizures the subject has, he/she will have the choice to continue taking the study drug for an extended time. There will be 4 total study site visits during the extension phase.
Study assessments:
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.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Afinitor tablets will be administered at a starting dosage of 5 mg/ m2/ day, dosed once per day in the morning. To achieve appropriate doses for all subjects 2mg, 3mg, 5mg of everolimus Disperz tablets will be used. Subjects will take one or more of these tablets in combination to achieve the required dose. Dosages will be rounded to the nearest 2 mg when calculating doses for individual subjects.
Drug: Everolimus
Afinitor tablets will be administered at a starting dosage of 5 mg/ m2/ day, dosed once per day in the morning. To achieve appropriate doses for all subjects 2mg, 3mg, 5mg of everolimus Disperz tablets will be used. Subjects will take one or more of these tablets in combination to achieve the required dose. Dosages will be rounded to the nearest 2 mg when calculating doses for individual subjects.
Also known as: Afinitor, RAD001
Evaluate the clinical effectiveness of Everolimus as an adjunct treatment to reduce the seizure activity
The primary efficacy parameter will be the percentage of subjects classified as responders (greater than 50% reduction in seizure frequency during the maintenance phase as compared to the baseline phase) or near-responders (25-50% reduction in seizure frequency during the maintenance phase as compared to the baseline phase), as reported by caregivers via seizure diaries.
Time frame: 2 years
Clinical progression of facial and/or body port-wine hemangioma
Presence and progression (location and size) of the facial and/or body port-wine hemangioma assessed during dermatological examinations. This will be done using an ordinal scale 0- None; 1-Pink and flat; 2- Red and flat; 3-Red and hypertrophied; 4- Red, hypertrophied and cobblestoning
Time frame: 2 years
Clinical progression of glaucoma
Presence and progression of glaucoma will be monitored through intraocular pressure assessment done at ophthalmologic exams.
Time frame: 2 years
The record gives a start of Apr 2014, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Everolimus