Nabilone for Non-motor Symptoms in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03773796
• Date of registration: 19/07/2018
• Prospective Registration: Yes
• Primary sponsor: Medical University Innsbruck
• Public title: Nabilone for Non-motor Symptoms in Parkinson's Disease NMS-Nab2
• Scientific title: Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy
• Date of first enrolment: August 6, 2018
• Target sample size: 48
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03773796
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria

Contacts

• Name: Klaus Seppi, Prof. MD

Key inclusion & exclusion 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 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 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 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).



Age minimum: 30 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Nabilone 0.25 mg

Primary Outcome(s)

The primary objective of this study is to evaluate AEs in PD patients taking nabilone. [Time Frame: 6 months]

The primary objective of this study is to evaluate the number of withdrawals in PD patients taking nabilone. [Time Frame: 6 months]

The primary objective of this study is to evaluate changes in supine and standing blood pressure measurements (mmHg) in PD patients taking nabilone. [Time Frame: 6 months]

The primary objective of this study is to evaluate suicidality in PD patients taking nabilone using the Columbia-Suicide Severity Rating Scale. [Time Frame: 6 months]

The primary objective of this study is to evaluate the incidence of AEs in PD patients taking nabilone. [Time Frame: 6 months]

The primary objective of this study is to evaluate changes in temperature (degree Celsius) in PD patients taking nabilone. [Time Frame: 6 months]

The primary objective of this study is to evaluate day-time sleepiness in PD patients taking nabilone. [Time Frame: 6 months]

The primary objective of this study is to evaluate orthostatic hypotension in PD patients taking nabilone. [Time Frame: 6 months]

The primary objective of this study is to evaluate changes in weight (kg) in PD patients taking nabilone. [Time Frame: 6 months]

The primary objective of this study is to evaluate subject compliance in PD patients taking nabilone. [Time Frame: 6 months]

The primary objective of this study is to evaluate hallucinations in PD patients taking nabilone. [Time Frame: 6 months]

Secondary Outcome(s)

The secondary objective of the study is to assess changes in non-motor symptoms (MDS-UPDRS Part I) in patients with PD taking nabilone. [Time Frame: 6 months]

The secondary objective of the study is to assess changes in cognitive function (MMSE) in patients with PD taking nabilone. [Time Frame: a maximum of 2 years, at study completion]

The secondary objective of the study is to assess changes in impulsive-compulsive behaviour in patients with PD taking nabilone. [Time Frame: 6 months]

The secondary objective of the study is to assess changes in cognitive function (MoCA) in patients with PD taking nabilone. [Time Frame: a maximum of 2 years, at study completion]

The secondary objective of the study is to assess changes in non-motor symptoms (HAD-S) in patients with PD taking nabilone. [Time Frame: 6 months]

The secondary objective of the study is to assess changes in pain in patients with PD taking nabilone. [Time Frame: 6 months]

The secondary objective of the study is to assess changes in quality of life in patients with PD taking nabilone. [Time Frame: 6 months]

The secondary objective of the study is to assess changes in motor and non-motor symptoms in patients with PD taking nabilone. [Time Frame: 6 months]

The secondary objective of the study is to assess changes in non-motor symptoms (NMSS) in patients with PD taking nabilone. [Time Frame: 6 months]

The secondary objective of the study is to assess changes in fatigue in patients with PD taking nabilone. [Time Frame: 6 months]

The secondary objective of the study is to assess changes in sleepiness in patients with PD taking nabilone. [Time Frame: 6 months]

The secondary objective of the study is to assess changes in overall symptoms in patients with PD taking nabilone. [Time Frame: 6 months]

Secondary ID(s)

1.3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors