Nabilone for Non-motor Symptoms in Parkinson's Disease

NCT03769896 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-03-02

Study results available

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.

Conditions

Parkinson Disease

Interventions

DRUG

Nabilone 0.25 mg

capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis

DRUG

Placebo

capsule, corn starch, daily basis

Sponsors & Collaborators

Medical University Innsbruck
lead OTHER

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: QUADRUPLE
Model: PARALLEL

Eligibility

Min Age: 30 Years
Max Age: 100 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2017-10-03
Primary Completion: 2019-07-15
Completion: 2019-07-15

Countries

Austria

Study Locations

More Related Trials

Entities

Drugs

Placebo