好色先生

好色先生

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Abstract Details

Tuberous Sclerosis Complex (TSC)–Associated Neuropsychiatric Disorder (TAND) Outcomes Following Add-on Cannabidiol (CBD) Treatment: 3-Month Analysis of Open-Label Phase 3b/4 Trial EpiCom
Epilepsy/Clinical Neurophysiology (EEG)
P8 - Poster Session 8 (8:00 AM-9:00 AM)
9-005
To investigate behavioral and co-occurring outcomes after initiation of add-on CBD treatment in patients with TSC who experience seizures (NCT05864846).
Epidiolex® is a plant-derived highly purified pharmaceutical formulation of CBD approved for treatment of seizures associated with TSC; anecdotal evidence suggests neuropsychiatric improvements. 
In this open-label study, participants received CBD (100 mg/mL oral solution) ≤25 mg/kg/day and standard of care (SOC) for 26 weeks, followed by CBD with SOC/SOC alone up to 52 weeks. Most problematic behavior (MPB) on TAND Self-Report Quantified Checklist (TAND-SQ) and Aberrant Behavior Checklist (ABC) were assessed at week 13, and Caregiver Global Impression of Severity (CareGI-S) and Clinician Global Impression of Severity (CGI-S) scales were assessed at weeks 4 and 13. 
Of 24 participants enrolled, 19 started CBD (median [range] age 21 [5–42] years); ≥1 postbaseline assessment was available for 17. A median (range) of 3 (1–5) antiseizure medications were used. At baseline, MPB numerical rating scale (NRS) value was 8.8 (1.01), suggesting severe TAND problems. At week 13 (n=5), mean (95% CI) change from baseline in MPB NRS was −4.6 (−8.1, −1.1). Greatest changes were in dysregulated behavior (−3.5 [−6.5, −0.5]) and overactivity/impulsivity scores (−2.9 [−7.1, 1.3]) among 7 TAND-SQ clusters and in irritability (−12.2 [−22.3, −2.1]) and hyperactive noncompliance (−11.0 [−25.1, 3.1]) in ABC. Compared with baseline, smaller proportions of caregivers and clinicians rated behavioral problems as severe/very severe at weeks 4 and 13, respectively (severe: 41%, 7%, 0% [CareGI-S] and 38%, 7%, 0% [CGI-S]; very severe: 6%, 0%, 0% [for both]). Adverse events occurred in 12/19 participants (63%); most common were diarrhea (42%), vomiting, decreased appetite, and lethargy (11% each). 
After initiating CBD, improvements were seen on TAND-SQ and ABC subscales and in severity of psychiatric and behavioral problems reported by caregivers and clinicians. 
Authors/Disclosures
Sarah L. Wilson, MD (UT Houston Medical School)
PRESENTER 		Dr. Wilson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz Pharmaceuticals.
Agnies van Eeghen, PhD The institution of Dr. van Eeghen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz Pharmaceuticals . The institution of Dr. van Eeghen has received research support from jazz pharmaceuticals . The institution of Dr. van Eeghen has received research support from ForWishdoem . The institution of Dr. van Eeghen has received research support from European Commission / ERN ITHACA .
Douglas M. Smith, MD (Minnesota Epilepsy Group) Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pyros Pharma. Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz Pharmaceuticals. Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Upsher-Smith. Dr. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. Dr. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB.
Roy E. Strowd III, MD, FAAN (Wake Forest School Of Medicine) Dr. Strowd has received personal compensation for serving as an employee of Kaplan. Dr. Strowd has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Monteris Medical, Inc. Dr. Strowd has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novocure. The institution of Dr. Strowd has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SpringWorks . Dr. Strowd has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for 好色先生. The institution of Dr. Strowd has received research support from Southeastern Brain Tumor Foundation. The institution of Dr. Strowd has received research support from Jazz Pharmaceuticals. The institution of Dr. Strowd has received research support from National Institutes of Health. The institution of Dr. Strowd has received research support from Alpha Omega Alpha. The institution of Dr. Strowd has received research support from American Board of Psychiatry and Neurology. Dr. Strowd has received publishing royalties from a publication relating to health care. Dr. Strowd has received publishing royalties from a publication relating to health care.
Jane Boggs, MD (Wake Forest University neurology) The institution of Dr. Boggs has received research support from Liva Nova. Dr. Boggs has a non-compensated relationship as a Chairman PAB with Epilepsy Alliance North Carolina that is relevant to AAN interests or activities.
Teresa Greco Teresa Greco has nothing to disclose.
Joanne Stevens, BA (Jazz Pharmaceuticals) Ms. Stevens has stock in Jazz Pharmaceuticals.
Lisa Moore-Ramdin, MBBS Dr. Moore-Ramdin has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Moore-Ramdin has stock in Jazz Pharmaceuticals.