Nabilone for Non-motor Symptoms in Parkinson's Disease

  • STATUS
    Recruiting
  • participants needed
    48
  • sponsor
    Medical University Innsbruck
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Updated on 19 February 2024
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parkinson's disease
motor symptoms

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 Parkinsons 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.
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.

Description

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 Parkinsons Disease. Nabilone is an analogue of tetrahydrocannabinol (THC), the psychoactive component of cannabis.
Eligible subjects will be re-tapered with open-label nabilone, optimally up to the dose the patient had in the NMS-Nab Trial. It is the investigators decision to modify this dose, if necessary. The re-tapering will be performed up to a maximum dose of 1 mg twice daily. Treatment responders will enter the open-label treatment period for 6 months with visits being performed every 3 months in the context of the patients regularly scheduled visits in the specialized outpatient department. The last visit will be the Termination Visit. Following this, nabilone will be tapered. During this period the patients will receive phone calls every other day. A Safety Follow-Up Visit will be performed.

Details
Condition Parkinson's Disease, Parkinson's Disease
Age 30-100 years
Treatment Nabilone 0.25 mg
Clinical Study IdentifierNCT03773796
SponsorMedical University Innsbruck
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

In order to be eligible for participation in the study, subjects must meet all
inclusion
criteria
In order to be eligible for the study, patients must have completed the double-blind phase of the NMS-Nab trial as responders within the last 2 months
For patients that completed NMS-Nab Study over 2 months prior to the Screening / Baseline Visit, and meet all other inclusion criteria, eligibility should be discussed on a case-by-case basis
Only patients without a drug-related serious adverse event (SAE) or moderate or severe AE during the NMS-Nab Study can be included in the study
Patients must be able and willing to provide written informed consent prior to any study related procedure being performed. Patients with a legal guardian should be consented according to local requirements
Patients must be willing and able to take oral medication and able to comply with the study specific procedures
The patient is in good health as determined by medical examination and based on the investigator's judgement

Exclusion Criteria

Patients with any of the following characteristics will be excluded from
entering the
study
Patients with PD who have not participated in the randomized double-blind phase of the previous NMS-Nab Study
Patients that experienced a drug-related SAE or had a moderate or severe AE during the NMS-Nab Study will be excluded in the study
Patients who are unable or unwilling to comply with the study procedures in the investigators opinion
Patients with any clinically significant or unstable medical or surgical condition at the Screening / Baseline Visit that may preclude safety and the completion of the study participation (based on the investigator's judgement)
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