Page 97 - Demo

Cannabidiol for severe behavioral manifestations in TSC, MPS III, and FXS954Enrollment*AllocationBaselineDose titrationTaperWashoutCycle 1Cycle 2Follow-upTime point (weeks; variable) 0 2 5 7 8-31 32-55Enrolment Eligibility screen XInformed consent XAllocation XInterventions CBD X X X X XPlacebo X X XAssessments VABS-III XEEG recordings XABC irritability (weekly) X X X XTotal ABC X X X XCGI X X X XSyndrome-specific outcome measures / PedsQLX X X XADAMS X X X XSCQ X X X XSRS-2 X X X XSSP X X X XOBVL X X X XGAS X X X X XPQ X X X X XSeizure frequency X X X X X X XHepatic enzyme levels X X X X XSide effects X X X X XFigure 2. Time schedule of enrolment, interventions, and assessments.Crosses (X) indicate research steps to be conducted. Underlined crosses (X) indicate assessments via phone calls. ABC, Aberrant Behavior Checklist; ADAMS, Anxiety, Depression, and Mood Scale; CBD, cannabidiol; CGI, Clinical Global Impression; EEG, electroencephalogram; GAS, Goal Attainment Scaling; OBVL, parenting stress questionnaire; PedsQL, Pediatric Quality of Life Inventory; PQ, personal questionnaire; SCQ, Social Communication Questionnaire; SSP, Short Sensory Profile; SRS-2, Social Responsiveness Scale; VABS-III, Vineland Adaptive Behavior Scale-III. In case of a drop-out, completed weeks before withdrawal will still be analyzed and a new participant will be recruited with a newly randomized sequence.Annelieke Muller sHL.indd 95 14-11-2023 09:07