Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson Disease: Interim Report on Tolerability (1592)

Objective: To determine the tolerability of relatively high cannabidiol (CBD) and low 9-D-tetrahydrocannabinol (THC) in Parkinson disease (PD).

Background: Cannabis use is frequent in PD, despite limited data regarding its effects.

Design/Methods: This randomized, double-blind, controlled, parallel study investigates a CBD cannabis extract (from National Institute of Drug Abuse) oral sesame oil solution with 100 mg/ml CBD and 3.33 mg/ml THC. Study drug started at 1.25 mg/kg/day, and increased to 2.5 mg/kg/day CBD (taken twice daily) for 10–14 days.

Results: Between 09/2018 and 04/2020, 51 persons enrolled, and 41 (66% men) took study drug: mean age 69.2 (SD 7.4), H&Y 2.6 (0.6). Mean final dose was 2.3 (0.4) mg/kg/day, i.e., 189 (55) mg CBD and 6.3 (1.8) mg THC, and participants were on study drug for 17.3 (7.0) days.

Unblinded study staff assigned participant data to two groups according to treatment randomization, which were matched in age, sex and H&Y. Group A (n=22), reported AEs 206 times, and 19 (86%) reported an AE: dizziness (56%); fatigue, feeling of relaxation, headache, decreased concentration, (36%); feeling abnormal, feeling drunk, nausea, somnolence (27%); confusion, (23%); dry mouth, fall, increased appetite (18%); agitation, disorientation, increased concentration, thinking abnormal, weakness (14%). Group B (n=19) reported AEs 93 times, and 17 (89%) reported an AE: headache (37%); somnolence (28%); feeling of relaxation (21%); cold, cough, diarrhea, fatigue, insomnia, nausea, (16%); anorexia, decreased concentration, depression, dizziness, elevated mood, feeling drunk (11%). Most AEs were mild; in Group A they occurred more at 1.25 mg/kg/day, in Group B at 2.5 mg/kg/day. Two serious AEs occurred in Group A, none in Group B. No significant changes in physical exam, safety labs and EKG occurred. One participant withdrew due to intolerance.

Conclusions: Interim data suggests relatively high CBD/low THC (likely Group A) is tolerated in PD, with many mild AEs.

Disclosure: Dr. Leehey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Connected Research and Consulting. Dr. Leehey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Leehey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Trinity Partners. Dr. Leehey has received personal compensation in the range of $0-$499 for serving as a Consultant for Sphenix Global Insight. Dr. Leehey has received personal compensation in the range of $0-$499 for serving as a Consultant for Olson Research Group. The institution of Dr. Leehey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Iris Medicine. The institution of Dr. Leehey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Huron Consulting Services. Dr. Leehey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Zynerba. The institution of Dr. Leehey has received research support from Michael J Fox Foundation. The institution of Dr. Leehey has received research support from Colorado Dept of Public Health and Environment. The institution of Dr. Leehey has received research support from Biogen. The institution of Dr. Leehey has received research support from US World Meds. The institution of Dr. Leehey has received research support from Vtesse. The institution of Dr. Leehey has received research support from NeuroDerm. The institution of Dr. Leehey has received research support from Denali. Ying Liu has nothing to disclose. The institution of Stefan Sillau has received research support from Alzheimer's Association. The institution of Stefan Sillau has received research support from Hewitt Family Foundation; State of Colorado. The institution of Stefan Sillau has received research support from PCORI. The institution of Stefan Sillau has received research support from NINR. The institution of Stefan Sillau has received research support from Michael J. Fox Foundation. The institution of Stefan Sillau has received research support from Department of Defense. The institution of Stefan Sillau has received research support from Colorado Department of Public Health and Environment. The institution of Stefan Sillau has received research support from Benign Essential Blepharospasm Research Foundation. Stefan Sillau has a non-compensated relationship as a Statistician with Novartis that is relevant to AAN interests or activities. Stefan Sillau has a non-compensated relationship as a Statistician with Biogen that is relevant to AAN interests or activities. The institution of Sarah Fischer has received research support from Colorado Department of Public Health and Environment. The institution of Sarah Fischer has received research support from Colorado Department of Public Health and Environment. The institution of Jost Klawitter has received research support from NIH. Cristina Sempio has nothing to disclose. Dr. Fullard has received research support from American Brain Foundation, Parkinson Foundation, American Academy of Neurology. Dr. Hawkins has nothing to disclose. Dr. Seeberger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Reata. Dr. Seeberger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avexis. The institution of Dr. Seeberger has received research support from Biohaven. The institution of Dr. Seeberger has received research support from VACCINEX. The institution of Dr. Seeberger has received research support from Intec. Emil DiGuilio has nothing to disclose. David Vu has nothing to disclose. Tristan Seawalt has nothing to disclose. Grace Chin has nothing to disclose. The institution of Dr. Bainbridge has received research support from CDPHE. The institution of Dr. Bainbridge has received research support from CDPHE.