drugset / Trial / NCT03773796

Nabilone for Non-motor Symptoms in Parkinson's Disease

NCT03773796

Phase 3 Completed 22 enrolled Medical University Innsbruck
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label extension study for participants of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study, assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients with Parkinson´s Disease (PD). 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. Eligible patients will be re-tapered in an open-label nabilone dose optimization phase followed by an open-label period of 6 months on a stable nabilone dose.

Timeline

Start
2018-08-06
Primary completion
2020-01-31
Completion
2020-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nabilone Other / unclassified 0.25 mg Oral
Subject Nabilone Other / unclassified 2 mg Oral

Indications