Clinical trial NCT03773796: Nabilone for Non-motor Symptoms in Parkinson's Disease
Official title: Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: Parkinson´s Disease
cannabinoids
non-motor symptoms
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label
Primary purpose: TREATMENT

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.

Detailed 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 Parkinson´s 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 investigator´s 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 patient´s 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.

Eligibility criteria: Inclusion Criteria:

In order to be eligible for participation in the study, subjects must meet all inclusion criteria:

1. 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.
2. 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.
3. 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
4. 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.
5. Patients must be willing and able to take oral medication and able to comply with the study specific procedures.
6. 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:

1. Patients with PArkinson´s Disease (PD) who have not participated in the randomized double-blind phase of the previous NMS-Nab Study.
2. 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.
3. Patients who are unable or unwilling to comply with the study procedures in the investigator´s opinion.
4. 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).

Primary outcomes:
measure: AEs in PD Patients Taking Nabilone, Between V 1 and V 3
timeFrame: 6 months
measure: Number of Subjects (%) Who Discontinue the Study Due to an AE Between V 1 and V 3
timeFrame: 6 months
measure: Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3
timeFrame: 6 months
measure: Suicidality in PD Patients Taking Nabilone Between V 1 and V 3 Using the Columbia-Suicide Severity Rating Scale
timeFrame: between V 1 and V 3 (6 months)
measure: Hallucinations in PD Patients Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Day-time Sleepiness in PD Patients Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Orthostatic Hypotension in PD Patients Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Subject Compliance in PD Patients Taking Nabilone.
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
Secondary outcomes:
measure: Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Non-motor Symptoms (NMSS) in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Non-motor Symptoms (HADS) in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Quality of Life in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Fatigue in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Pain in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Impulsive-compulsive Behaviour in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Overall Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: between V 1 and V 3 (6 months)
measure: Changes in Cognitive Function (MoCA) in Patients With PD Taking Nabilone Between V 1 and V 3
timeFrame: from Screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion)
measure: Changes in Cognitive Function (MMSE) in Patients With PD Taking Nabilone
timeFrame: from screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion)
Other outcomes:
measure: Eye-tracking Evaluation in PD Patients Taking Nabilone at Visit V 2 to Assess Changes in Reaction Time.
timeFrame: a maximum of 2 years, measurement at V2 visit
measure: Eye-tracking Evaluation in PD Patients Taking Nabilone at Visit V 2 to Assess Changes in Attention Span.
timeFrame: a maximum of 2 years, measurement at V2 visit
measure: Eye-tracking Evaluation in PD Patients Taking Nabilone at Visit V 2 to Assess Changes in the Ability to Concentrate.
timeFrame: a maximum of 2 years, measurement at V2 visit
Locations:
city: Innsbruck
country: Austria
facility: Department of Neurology - Medical University Innsbruck
state: Tyrol
Study officials:
References: