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Weber Syndrome

Pharmaceutical Solutions

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Anti-Infective Agents

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Sirolimus

Temsirolimus

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Immunologic Factors

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.

Anne M Comi, M.D.

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.

Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome

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.

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).

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.

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.

Children's Hospital Medical Center, Cincinnati

Pfizer

National Institutes of Health (NIH)

Faneca 66 Foundation

National Institute of Neurological Disorders and Stroke (NINDS)

Anne Comi, MD

Principal Investigator, Director Sturge-Weber Center, Kennedy Krieger Institute, Professor Johns Hopkins University School of Medicine

The Rare Diseases Clinical Research Network defines an adverse event as "...an unfavorable and unintended sign, symptom or disease associated with a participants' participation in a Rare Disease Clinical Research Network Study." The three types of adverse events are serious adverse events, unexpected adverse events and expected adverse events. This classification is using Common Terminology Criteria for Adverse Events developed and maintained by CTEP at National Cancer Institute.

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.

Sirolimus: Low dose oral sirolimus

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Research Assistant

National Institute of Health Toolbox Vocabulary Baseline

National Institute of Health Toolbox Vocabulary Follow-up

National Institute of Health Toolbox Attention Baseline

National Institute of Health Toolbox Attention Follow-up

National Institute of Health Toolbox Working Memory Baseline

National Institute of Health Toolbox Working Memory Follow-up

National Institute of Health Toolbox Executive Function Baseline

National Institute of Health Toolbox Executive Function Follow-up

National Institute of Health Processing Speed Baseline

National Institute of Health Processing Speed Follow-up

National Institute of Health Toolbox Sequential Memory Baseline

National Institute of Health Toolbox Sequential Memory Follow-up

National Institute of Health Toolbox Recognition Baseline

National Institute of Health Toolbox Recognition Follow-up

Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Baseline

Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Follow-up

Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Baseline

Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Follow-up

Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Baseline

Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Follow-up

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

Patient-Reported Outcomes Measurement Information System Pain (PROMIS) Interference Follow-up

Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Baseline

Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Interference Follow-up

Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relations Baseline

Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relations Follow-up

Grip Strength Dominant Baseline

Grip Strength Dominant Follow-up

Grip Strength Non-Dominant Baseline

Grip Strength Non-Dominant Follow-up

Dexterity Dominant Baseline

Dexterity Dominant Follow-up

Dexterity Non-Dominant Baseline

Dexterity Non-Dominant Follow-up

Change in Cognitive Function as Assessed by the National Institute of Health (NIH) Toolbox Cognitive Battery

Patients with Stroke-Like Episodes Baseline

Patients with Stroke-Like Episodes Follow-up

Patients without Stroke-like episodes Baseline

Patients without stroke-line episodes follow-up

Difference in Mean Power Asymmetry of the Occipital Alpha Frequency Band

Composite Score Baseline

Composite Score Follow-up

Seizure Score Baseline

Seizure Score Follow-Up

Hemiparesis Score Baseline

Hemiparesis Score Follow-up

Visual Field Cut Score Baseline

Visual Field Cut Score Follow-up

Cognitive Function Score Baseline

Cognitive Function Score Follow-Up

Change in Sturge-Weber Syndrome Clinical Neuroscore

Number of Participants With a Change in Sturge-Weber Syndrome Birthmark Score

Overall Study

Anti-Arrhythmia Agents

Antihypertensive Agents

Timolol

Lubricant Eye Drops

Maleic acid

Ophthalmic Solutions

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Participants in this group will receive topical timolol

Participants in this group will receive Preservative free artificial tear gel.

0.5% timolol maleate ophthalmic gel-forming solution applied once

Preservative free artificial tear gel applied topically twice a day.

Preservative free artificial tear gel.

Alex V Levin, MD, MHSc

Primary Objective:

• To assess the possible utility of topical timolol in the management of port-wine mark (PWM) in Sturge-Weber syndrome in children.

Port-wine mark (PWM) represents a congenital capillary malformation,characterized by dilation and malformation of dermal capillaries that lack endothelial proliferation. It is frequently seen in the facial distribution of the trigeminal nerve. PWM persists throughout life and involves \~0.3% of the population. Although PWMs are found in other circumstances, \~ 3% of patients with facial PWM are also afflicted with Sturge-Weber syndrome. PWMs are cosmetic entities that often have serious social consequences, producing psychological trauma to both children and their parents. PWM does not involute with time, and, if left untreated, can develop deep purple coloration, tissue hypertrophy, and nodularity.

Laser therapy, which selectively destroys specific targets within the skin, is currently the most commonly used approach for treating PWM, although complete blanching of the PWM after laser is rarely achieved for most patients, and only 10-45% of patients with Sturge-Weber have shown satisfactory outcomes. Complications of pulsed dye laser treatment for PWM include pyogenic granuloma, scabbing, cutaneous scarring, and permanent hypo/hyperpigmentation. Laser treatment is relatively contraindicated in children with darker skin coloration due to the resulting hypopigmentation which may be equally unsightly. Laser treatment causes substantial discomfort and pain to patients, and often requires general anesthesia in children. This is particularly true since earlier treatment in infancy is desirable and yields increased successful resolution of the PWM. The hypertrophic PWM in later years is resistant to any treatment. Recently, propranolol was reported to successfully treat capillary hemangioma in infants.13 While the mechanism by which beta blockade improves hemangioma is unclear, ß2-mediated vasoconstrictive effects and the ensuing apoptosis of capillary endothelial cells may contribute to the positive therapeutic results.

Oral application of propranolol can cause severe systemic complications, including bronchospasm, vasospasm, hypoglycemia, hypotension, severe bradycardia, heart block, and congestive heart failure. Topical timolol solution, a β-blocker, has shown a similar ability to reduce capillary hemangioma of eyelids with little or no systemic effects in a small pilot study. Similar to capillary hemangioma, which is a proliferative lesion characterized by increased endothelial cell turnover, PWM is a capillary malformation with abnormal endothelial cells and large surface area of dilated capillaries. Thus, both capillary hemangioma and PWM share the similar characteristic of abnormal capillary endothelial cells.

This pilot study is designed to explore the potential role of topical timolol in the management of PWM. As PWM is so frequently associated with Sturge-Weber syndrome, a disorder in which approximately 50% of patients will develop glaucoma, this study will be conducted in an ophthalmology setting.

This study will consist of two arms. One group will receive timolol and the second group a placebo preservative free artificial tear gel. The groups will be divided with a ratio of 1:1 and the Timolol group will be matched with the placebo group by PWM location, age and race.

Both medications are to be applied and rubbed in by fingertip to the treatment site twice a day for 6 months by subject's parents/guardian. (Treatment site: 1x1 cm at inferior edge of facial PWM)

Follow-up schedule: 1 week after treatment initiation and then every 2 months for a period of six months.

Treatment of Port-wine Mark in Sturge-Weber Syndrome Using Topical Timolol

Changes of color and size of PWM at treatment site will determine efficacy of the topical timolol.

University of Medicine and Dentistry of New Jersey

Wills Eye

Chief, Pediatric Ophthalmology and Ocular Genetics

Anticonvulsants

Cannabidiol

All subjects will receive the experimental Epidiolex (cannabidiol) oral solution to be taken at home twice a day, and will be treated on an outpatient basis. The drug will be taken for 24 weeks unless the subject chooses to participate in the extension phase of the study, in which case the subject will continue to receive the drug for one additional year or until the drug is approved for clinical use for the treatment of cognitive impairments in patients with Sturge-Weber syndrome.

Initiation of treatment will begin with 5 mg/kg/day given in two divided doses. The dose will be increased by 5 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 20 mg/kg/day given.

Anne M Comi, MD

The purpose of this study is to better understand the utility of cannabidiol (CBD/ Epidiolex) for improving the treatment of cognitive impairments in Sturge-Weber syndrome (SWS).

The investigators hope to gain an understanding of the utility of pharmaceutical grade CBD used for the treatment of cognitive impairments in SWS in this open-label study. Anecdotal evidence from a phase I trial investigating the use of CBD for medically refractory seizures suggests CBD may also have a beneficial effect on cognition, mood, and behavior. The investigators hypothesize that CBD/ Epidiolex will improve SWS brain function resulting in improved cognitive function, social interactions, mood, motor function and behavior, as well as reduced migraines. This is an open-label prospective oral drug trial of Epidiolex in 10 subjects. Assessments will be done at baseline and repeated after 6 months on study drug.

Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome

Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome: A Phase II Trial

Data on cognitive function was collected using the List Sorting Working Memory Test from the NIH Toolbox. Data was collected on working memory performance, which was transformed into a t-score from 0 to 100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and after 6 months on study drug.

Data on cognitive function was collected using the Picture Vocabulary subtest from the NIH Toolbox. Single words are presented via an audio file, paired simultaneously with 4 screen images of objects, actions, and/or depictions of concepts. The task is to pick the picture that matches the spoken word. Performance on the task was transformed into a t-score from 0 to 100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and after 6 months on study drug.

Change in seizure frequency by seizure score at pre-treatment baseline and after six months. The seizure score is taken from the Sturge-Weber Neuroscore on a scale of 0 to 4 where 0=none, 1=1+. but controlled, 2=Breakthrough, 3=monthly, 4=Weekly+. Higher scores indicate worse outcome.

Data on migraine severity will be collected using patient responses to questions on a standard six-point scale. Data will be collected on the frequency of an event (e.g. feelings of frustration, performance of daily activities) which will be transformed into a score from 0 to 100 where higher scores indicate a less migraine severity and better outcomes. Data will be collected at baseline and after 6 months on study drug.

Data on motor function was collected using a Modified House Classification. Data was collected on the ability to complete a task with the subject's non-dominant hand which was transformed into a score from 1 to 8 and 0 to 32 where higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug.

Data on motor function was collected using the Erhardt Developmental Prehension assessment. Data was collected on the ability to complete a task with each hand, which was scored as age equivalence of task performance (in months). Higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug.

Data on motor function was collected using the Pediatric Evaluation of Disability Inventory Computer Adapted Test. Data was collected on the subject's ability to complete tasks involved in daily activities, mobility, and social/ cognitive activities. The data was transformed into scaled scores ranging from 20 to 80, where higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug.

Data on motor function was collected using the ABILHAND questionnaire, a measure of manual ability for adults with upper limb impairments. Data was collected on the subject's ability to complete daily activities that involve the upper limbs. Score was collected as a patient measure with scores ranging from -10 to 10. Higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug.

Data on cognitive function was collected using selected subtests, from either the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale (WAIS-IV). For the WISC-V and WAIS-IV subtests selected, scaled scores were derived from the normative data which account for age and demographic information. The selected WISC-V/WAIS-IV subtests were as follows: Digit Span, Symbol Search, Coding and Processing Speed; the first three subtests were scored from 0-10, the fourth subtest from 0-100, and for all subtests higher score is better. The selected subtests, from the WISC-V and the WAIS-IV, were combined to increase statistical power.

Statistically rare changes in individual test scores were determined using a reliable change index methodology based upon normative information for these assessments.

Data on cognitive function was collected using Neurological Quality of Life scales from the NIH Toolbox. Data on frequency of an event (e.g. forgetting schoolwork) was collected and transformed into a t-score from 0 to 100 where higher t-scores indicate worse anger, worse anxiety, worse pain, better social relationships, worse stigma, worse depression, better cognitive function, and worse fatigue. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug.

Data on executive function was collected using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). Data on the frequency of an event (e.g. becomes upset too easily) was collected and transformed into a t-score. The following BRIEF-2 subtests were evaluated: Behavioral Regulation Index, Emotional Regulation Index, Cognitive Regulation Index, and Global Executive Composite. For each BRIEF-2 subtest, t-scores range from 0 to 100; a score of 50 indicates the population mean with a standard deviation of 10. For all BASC-3 subtests, higher scores are worse outcome.

Data on social function was collected using the Social Responsiveness Scale-Second Edition (SRS-2). Data on a child's ability to engage in emotionally appropriate reciprocal social interactions in naturalistic settings was collected and transformed into a t-score from 0 to 100 where higher scores indicate greater impairment in social function. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug.

Data on behavioral function was collected using the Behavioral Assessment System for Children, Third Edition (BASC-3). Data on the frequency of a behavior (e.g. avoids eye contact) was collected and transformed into a t-score. Subscales for the BASC-3 scored were: External Problems Composite, the Internal Problems Composite, the Behavioral Symptoms Index, and the Adaptive Skills Composite. For the first three subscales, lower t-score indicates better outcome; for the fourth, a lower t-score indicates worse outcome. T-scores for all the BASC-3 subscales range from 0 to 100, and a t-score of 50 indicates the population mean with a standard deviation of 10.

Data on anxiety was collected using the Screen for Child Anxiety Related Disorders (SCARED). Data on the truthfulness of a statement (e.g. I am nervous) was collected and transformed into a score from 0 to 82 where higher scores indicate greater anxiety. Data was collected at baseline and 6 months on study drug.

Data on quality of life was collected using the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55). Data on the frequency of an event (e.g. had trouble concentrating on a task) was collected and transformed into a score from 0 to 100 where higher scores reflect better quality of life. Data was collected at baseline and 6 months on study drug.

Safety of Epidiolex was measured by the number of adverse events and serious adverse events that result from study drug.

Data on neurological function was collected using the Neuroscore. Data on frequency of seizures, extent of hemiparesis, assessment of visual field cut, and degree of cognitive functioning was transformed into a score from 0 to 15 where higher scores indicate worse neurologic function. Data was collected at baseline and 6 months on study drug.

Data on facial port-wine birthmarks was collected using the Port-wine Birthmark Score. Data on percent of face covered, thickness of birthmark, and darkness of birthmark color was collected and transformed into a score from 0 to 43 where higher scores indicate greater severity and greater surface area involved. Data was collected at baseline and 6 months on study drug.

Data on cognitive function was collected using Neurological Quality of Life scales from the NIH Toolbox. Data on frequency of an event was collected and transformed into a t-score from 0 to 100. Higher t-scores indicate better communication, better ability to participate in social activity, worse anxiety, worse depression, worse emotional and behavioral dyscontrol, worse fatigue, better positive affect, worse sleep disturbance, better lower and upper extremity functions, worse stigma, better satisfaction with social roles, and better cognitive function. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug.

Jazz Pharmaceuticals

Serious adverse events include those events that: result in death; are life-threatening; require hospitalization or prolongation of existing hospitalization; create persistent, significant disability, or birth defects.

Expected adverse events are those that are identified in the research protocol as having been previously associated with participation in the study. All reported adverse events will be classified using the Common Terminology Criteria for Adverse Events Version 4.0.

All subjects will receive the experimental Epidiolex (cannabidiol) oral solution to be taken at home twice a day, and will be treated on an outpatient basis. The drug will be taken for 24 weeks unless the subject chooses to participate in the extension phase of the study, in which case the subject will continue to receive the drug for one additional year or until the drug is approved for clinical use for the treatment of cognitive impairments in patients with Sturge-Weber syndrome.

Cannabidiol: Initiation of treatment will begin with 5 mg/kg/day given in two divided doses. The dose will be increased by 5 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 20 mg/kg/day given.

Cannabidiol/ Epidiolex

Subjects took oral cannabidiol for 6 months (doses ranged from 5 mg/kg/day to 20 mg/kg/day). Neuropsychological, psychiatrics and motor assessments were administered at baseline and six months follow-up.

Brain Involvement

Skin Involvement

Eye Involvement

Due to the COVID-19 , visits transitioned from an in-person setting to a remote setting. Four subjects had baseline testing conducted in person and follow-up virtually, and 5 subjects had both baseline and follow-up testing virtually. The differences in testing environment and the context of the pandemic may have affected results. Also, due to variability in subject age and the small number of subjects, some participants were outside of assessment age norms.

Dr. Anne Comi

Baseline List Sorting Working Memory Fully Adjusted Score

Follow-Up List Sorting Working Memory Fully Adjusted Score

Subject 1 was unable to complete this assessment due to lack of understanding of the instructions. Subject 10 was unable to complete this assessment due to a system error, where the fully adjusted score was not obtained. Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.

List Sorting Working Memory Test

Baseline Mean of the Fully Adjusted Picture Vocabulary Score

Follow-up Mean of the Fully Adjusted Picture Vocabulary Score

Subject 10 did not complete this assessment due to a technical issue where the fully adjusted score was not calculated. Subject 9 was withdrawn from the study prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.

Picture Vocabulary Test

Baseline Seizure Score from Sturge-Weber Neuroscore

Follow-up Seizure Score from Sturge-Weber Neuroscore

Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome	NCT03047980	Sturge-Weber Sy...	Sirolimus	3 Years - 31 Years	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome	NCT03047980	Sturge-Weber Sy...	Sirolimus	3 Years - 31 Years	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Treatment of Port-wine Mark in Sturge-Weber Syndrome Using Topical Timolol	NCT01533376	Sturge Weber Sy... Port-wine Mark	Timolol Preservative fr...	2 Years - 10 Years	Wills Eye
Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome	NCT04447846	Sturge-Weber Sy...	Cannabidiol	3 Years - 50 Years	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome	NCT03047980	Sturge-Weber Sy...	Sirolimus	3 Years - 31 Years	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Spots Global Cancer Trial Database for sws

Every month we try and update this database with for sws cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sws

Every month we try and update this database with for sws cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sws cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.