Cannabis Oil for Pain in Parkinson's Disease

Full Title: A phase II, randomized, open-label, double-blind, two-center study to evaluate the tolerability, safety and dose-finding of oil cannabis preparation for pain in Parkinson's disease. Short title: Cannabis oil for pain in Parkinson's disease Sample Size: N = 15 Study Population: Patients with Parkinson's disease and pain, without cognitive impairment. Study Duration: July 2018 - July 2019 Study Agent/ Intervention: Cannabis oil: mixed oil cannabis preparation consisting of 3 different formulations of ∆-9THC and cannabidiol - 18:0; 10:10; and 1:20 respectively. Cannabis oil will be administered orally once per day, as required for pain; or taken 4h before bedtime, if no pain. Primary objective: to determine the safety and tolerability of different formulations of Cannabis oil for pain in PD patients (incidence and severity of adverse events). Secondary objective: to assess change from the start of treatment (V2) to end of treatment (V5) in frequency and severity of pain, sleep, dystonia and motor symptoms in PD patients.