Nabilone for Non-motor Symptoms in Parkinson's Disease
Status:
Completed
Trial end date:
2019-07-15
Target enrollment:
Participant gender:
Summary
This is a randomized placebo-controlled, double-blind, parallel-group, enriched enrollment
randomized withdrawal study assessing the efficacy and safety of nabilone for non-motor
symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of
tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a
partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and
therefore mimics the effect of THC but with more predictable side effects and less euphoria.
Part 1 is an open-label dose adjustment phase of the study. In eligible patients, a screening
period is followed by an open-label nabilone dose optimization phase and a stable phase for
at least 1 week. Treatment responders will be included in Part 2 of the study (randomized
placebo-controlled, double-blind, parallel-grouped).
Part 2 is the placebo-controlled, double-blind, parallel-group randomized withdrawal phase of
the study.