Safety and tolerability of full spectrum cannabis oil (CBD:THC 10:1) for spasticity in children and young adults with cerebral palsy - preliminary results

Abstract

Objective: to evaluate the safety and tolerability of full spectrum cannabis oil (FSCO) with CBD: THC in a 10:1 ratio for the treatment of spasticity in patients aged 5-25 years with cerebral palsy (CP) GMFCS grade IV and V.

Methods: A pilot open-label study with 7 CP patients receiving FSCO was followed by a prospective double-blind randomized trial (DBT) with 33 participants. The double-blind phase (DBP) lasted 6 weeks, after which randomization was opened and FSCO was introduced to patients in the placebo arm, while patients in the FSCO arm opted to continue treatment over the next 6 weeks. Patient demographic characteristics and the frequency and occurrence of adverse effects (AE) were analysed.

Results: The median age of the patients was 15 years. The median FSCO dose, gradually titrated to AE or effect, was 0.29 mg/THC/kg body weight (BW) twice daily (range, 0.1-0.48 mg/THC/kg BW). The most common AE was drowsiness (in 50% of all 40 participants), followed by contact difficulty (30%), agitation (22.5%), nausea, and sleep disturbance (20% each). Seven patients (17%) reported no side effects, while others had some type of AE, median 3 with a range of 1-7 AE. In the DBP, the odds of side effects occurring were significantly higher (p=0.0028) in the FSCO group (N = 18) than in the placebo group (N = 15), while the odds of study discontinuation due to AE were not higher (p=0.12). In the DBP, a total of 11 patients (9 on FSCO and 2 on placebo) discontinued the study due to AE. In the other 22 patients who experienced any type of AE, dose adjustment resulted in relief AE.

Of all 38 patients in whom treatment with FSCO was initiated, 22 participants (57%) chose to continue treatment with FSCO at the end of the study period (week 12), and 12 (31%) of them continued treatment over the next six months.

Only three serious AE were reported: Two FSCO-treated patients experienced allergic reactions and fever during a respiratory infection; one patient receiving placebo experienced more frequent seizures. In the first two patients, AE ceased after discontinuation of FSCO, which was reintroduced without AE. The third patient discontinued the study drug (placebo), and seizures ceased.

Conclusions: The AE reported with FSCO therapy were quite frequent but mild to moderate in severity, and most of them could be controlled by dose adjustment, whereas 3 patients required treatment discontinuation. Our results suggest that FSCO is a safe option for the treatment of spasticity in children with CP grade IV and V.