Experimental Design
spasm
DRY EYE, RECRUITMENT, PTOSIS
Participating patients remained on a 3-month BTX injection cycle and were randomized to group A (adjunctive CBD + Botox in cycle 1 followed by placebo + Botox in cycle 2) or group B (placebo + Botox in cycle 1 followed by adjunctive CBD + Botox in cycle 2). Note that although both received BTX, these treatments are labeled “placebo” and “CBD” below for simplicity. Both participants and study staff, including the treating physician, were blinded as to the allocation. Medication was provided by Greenwich Biosciences, Inc. (Carlsbad, CA) in the form of sublingual CBD at 200 mg/day (100 mg BID) under the brand name of Epidiolex. The Epidiolex solution is a clear, colorless liquid with inactive ingredients, including dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.As an initial feasibility trial, dosing was low to establish safety before proceeding to a higher, potentially more efficacious dose (see Discussion). The placebo vehicle oil was also provided by Greenwich Biosciences in an identical vial with instructions to take the corresponding volume of oil. The recruitment and trial began in August of 2020.Patients underwent BTX injections placed according to the standard protocol developed by Dr. Alan Scott and others.The end point of BTX treatment was reached when patients achieved sufficient suppression of spasm or poorly tolerated side effects of BTX, such as weak blink, dry eye, or ptosis. Dosing, which had been established for these long-term patients, was continued without change during the study at the participants’ previously established treatment units (see the Patients were treated with BTX at days 0, 90, and 180 and were filmed at the 0, 45-, 90-, 135-, and 180-day time points, as outlined in Illustration of the two 3-month cycles to which patients were randomized. The y axis demonstrates the clinical effect of BTX on the orbicularis with the red curves showing the course of effect over the 90 day period.