Nabilone for Non-motor Symptoms in Parkinson's Disease

NCT03773796 | Completed Phase 3 Results

• 1 other identifier: 1.3
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson´s Disease; cannabinoids; non-motor symptoms

Outcome Measures

Primary Outcomes (9)

• AEs in PD Patients Taking Nabilone, Between V 1 and V 3

  Safety and tolerability will be evaluated with reference to the following: Adverse Events (AE)

  6 months

• Number of Subjects (%) Who Discontinue the Study Due to an AE Between V 1 and V 3

  Safety and tolerability will be evaluated with reference to the following: Number of subjects (%) who discontinue the study due to an AE The reasons for discontinuation will be grouped in "discontinuation due to an AE" and "discontinuation due to other reasons". Both results will be provided separately.

  6 months

• Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3

  Safety and tolerability will be evaluated with reference to the following: Number of subjects (%) who discontinue the study due to other reasons than an AE The reasons for discontinuation will be grouped in "discontinuation due to an AE" and "discontinuation due to other reasons". Both results will be provided separately.

  6 months

• Suicidality in PD Patients Taking Nabilone Between V 1 and V 3 Using the Columbia-Suicide Severity Rating Scale

  Change in aggregated data of the Columbia-Suicide Severity Rating Scale (C-SSRS). Different questions for suicidality with the possible answers yes or no. Yes represents a worse outcome. Count of participants with new suicidality is given.

  between V 1 and V 3 (6 months)

• Hallucinations in PD Patients Taking Nabilone Between V 1 and V 3

  Changes in points of the: Hallucination item (1.2) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Each item has a minimum of 0 and a maximum of 4 points with higher score values representing a worse outcome. Participant count with a change in the hallucination item is reported.

  between V 1 and V 3 (6 months)

• Day-time Sleepiness in PD Patients Taking Nabilone Between V 1 and V 3

  Changes in points of the: Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Each item has a minimum of 0 and a maximum of 4 points with higher score values representing a worse outcome.

  between V 1 and V 3 (6 months)

• Orthostatic Hypotension in PD Patients Taking Nabilone Between V 1 and V 3

  Changes in points of the: Orthostatic hypotension item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Each item has a minimum of 0 and a maximum of 4 points with higher score values representing a worse outcome.

  between V 1 and V 3 (6 months)

• Subject Compliance in PD Patients Taking Nabilone.

  subject incompliance as per drug accountability (%)

  between V 1 and V 3 (6 months)

• Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3

  changes in supine and standing blood pressure measurements (mmHg) Row titles: 1. Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at V 1 2. Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at V 3 3. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at V 1 4. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at V 3

  between V 1 and V 3 (6 months)

Secondary Outcomes (11)

• Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3

  between V 1 and V 3 (6 months)

• Changes in Non-motor Symptoms (NMSS) in Patients With PD Taking Nabilone Between V 1 and V 3

  between V 1 and V 3 (6 months)

• Changes in Non-motor Symptoms (HADS) in Patients With PD Taking Nabilone Between V 1 and V 3

  between V 1 and V 3 (6 months)

• Changes in Quality of Life in Patients With PD Taking Nabilone Between V 1 and V 3

  between V 1 and V 3 (6 months)

• Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3

  between V 1 and V 3 (6 months)

Other Outcomes (3)

• Eye-tracking Evaluation in PD Patients Taking Nabilone at Visit V 2 to Assess Changes in Reaction Time.

  a maximum of 2 years, measurement at V2 visit

• Eye-tracking Evaluation in PD Patients Taking Nabilone at Visit V 2 to Assess Changes in Attention Span.

  a maximum of 2 years, measurement at V2 visit

• Eye-tracking Evaluation in PD Patients Taking Nabilone at Visit V 2 to Assess Changes in the Ability to Concentrate.

  a maximum of 2 years, measurement at V2 visit

Study Arms (1)

Treatment Group

OTHER

Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg

Drug: Nabilone 0.25 mg

Interventions

Nabilone 0.25 mg DRUG

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

Also known as: Canemes

Treatment Group

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Only patients without a drug-related serious adverse event (SAE) or (drug-related) 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

You may not qualify if:

• Patients with any of the following characteristics will be excluded from entering the study:
• Patients with PArkinson´s Disease (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 (drug-related) 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 investigator´s 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).

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Department of Neurology - Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

nabilone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Prof. Klaus Seppi
• Organization: Medical University of Innsbruck

klaus.seppi@tirol-kliniken.at

004351250481553

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: None, open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: open-label

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: December 12, 2018
• Study Start: August 6, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 2, 2021
• Results First Posted: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)