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Nabilone for Non-motor Symptoms in Parkinson's Disease (NMS-Nab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03769896
Recruitment Status : Completed
First Posted : December 10, 2018
Results First Posted : March 2, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Klaus Seppi, MD, Medical University Innsbruck

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Drug: Nabilone 0.25 mg
Drug: Placebo
Enrollment 48
Recruitment Details location: Medical Clinic, period: October 2017 to July 2019
Pre-assignment Details Phase 1: open-label nabilone titration (0.25mg - 2mg). Phase 2: double-blind phase There was one screening failure due to the use of prohibited concomitant medication.
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Period Title: Open-label Phase
Started 47 0
Completed 38 0
Not Completed 9 0
Reason Not Completed
Lack of Efficacy             5             0
Adverse Event             3             0
Withdrawal by Subject             1             0
Period Title: Double-blind Treatment Phase
Started [1] 19 19
Completed [1] 19 19
Not Completed 0 0
[1]
refers to the double-blind treatment phase
Arm/Group Title Treatment Group Placebo Group Total
Hide Arm/Group Description

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis

 Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
baseline characteristics (as assessed at the screening visit) for the 38 randomized patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
65.38  (7.94) 63.95  (8.04) 65.05  (8.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
9
  47.4%
5
  26.3%
14
  36.8%
Male
10
  52.6%
14
  73.7%
24
  63.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
19
 100.0%
19
 100.0%
38
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
00
   0.0%
0
   0.0%
White
19
 100.0%
19
 100.0%
38
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 19 participants 19 participants 38 participants
19 19 38
Disease duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
7.83  (5.47) 7.39  (5.14) 7.61  (5.24)
Hoehn and Yahr Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 19 participants 38 participants
1.84  (0.50) 1.95  (0.41) 1.89  (0.45)
[1]
Measure Description:

Hoehn and Yahr scale:

  • is used to assess the severity / disease stage of Parkinson´s disease patients
  • 5-point Likert scale
  • the total score ranges from a minimum of 0 to a maximum of 5
  • higher values indicate worse status
  • The total score values are reported in this table.
MDS-UPDRS Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 19 participants 38 participants
52.05  (22.97) 52.05  (14.75) 52.05  (19.04)
[1]
Measure Description:

Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS)

  • Total score reported is the sum of Parts I to IV.
  • Part I minimum points: 0, maximum points: 52, Part II: minimum points: 0, maximum points: 52, Part III: minimum points: 0, maximum points: 132, Part IV: minimum points: 0, maximum points: 24.
  • Total MDS-UPDRS score: minimum: 0, maximum: 260.
  • Higher score values indicate a worse outcome.
MDS-UPDRS-I   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 19 participants 38 participants
13.53  (4.39) 12.26  (5.85) 12.89  (5.14)
[1]
Measure Description:

Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I

  • minimum points: 0, maximum points: 52.
  • higher score values indicate a worse outcome.
1.Primary Outcome
Title Changes of Non-motor Symptoms
Hide Description Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
1.00
(-0.16 to 2.16)
2.63
(1.53 to 3.74)
2.Secondary Outcome
Title Changes in Motor and Different Non-motor Symptoms of PD
Hide Description

Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part II: minimum points: 0, maximum points: 52, higher score values indicate a worse outcome.

Part III: minimum points: 0, maximum points: 132, higher score values indicate a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
MDS-UPDRS II
0.47
(-0.37 to 1.31)
0.90
(-0.35 to 2.14)
MDS-UPDRS III
0.53
(-2.24 to 3.29)
2.63
(0.25 to 5.02)
3.Secondary Outcome
Title Changes in Different Domains of Non-motor Symptoms of PD
Hide Description mood/anxiety domain of MDS-UPDRS Part I (items 1.3 and 1.4) and different other domains of NMSS and MDS-UPDRS part I Each items scores 0 to 4 points with higher score values indicating a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
MDS-UPDRS 1.3 Depressed Mood
0.11
(-0.17 to 0.38)
0.16
(-0.08 to 0.40)
MDS-UPDRS 1.4 Anxious Mood
-0.16
(-0.53 to 0.21)
0.21
(-0.05 to 0.47)
MDS-UPDRS 1.7 Nighttime sleep problems
0.05
(-0.47 to 0.57)
1.79
(1.15 to 2.42)
4.Secondary Outcome
Title Changes in Non-motor Symptoms of PD
Hide Description Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: score on a scale
4.05
(-0.65 to 8.75)
11.00
(4.68 to 17.32)
5.Secondary Outcome
Title Changes in Non-motor Symptoms of PD
Hide Description Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
Hospital anxiety and depression scale - Anxiety
0.26
(-0.87 to 1.40)
0.05
(-1.09 to 1.19)
Hospital anxiety and depression scale - Depression
0.32
(-1.11 to 1.74)
0.16
(-0.71 to 1.03)
6.Secondary Outcome
Title Changes in Non-motor Symptoms of PD
Hide Description Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
-0.74
(-1.87 to 0.40)
-0.79
(-1.85 to 0.27)
7.Secondary Outcome
Title Changes in Non-motor Symptoms of PD
Hide Description Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
-4.00
(-9.77 to 1.77)
0.00
(-5.26 to 5.26)
8.Secondary Outcome
Title Changes in Non-motor Symptoms of PD
Hide Description King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
1.58
(-2.73 to 5.89)
2.84
(-5.19 to 10.87)
9.Secondary Outcome
Title Changes in Non-motor Symptoms of PD
Hide Description Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
-0.68
(-1.49 to 0.12)
0.05
(-0.64 to 0.74)
10.Secondary Outcome
Title Changes in Non-motor Symptoms of PD
Hide Description Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
0.74
(-0.18 to 1.66)
0.00
(-0.63 to 0.62)
11.Secondary Outcome
Title Changes in Non-motor Symptoms of PD
Hide Description Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: millimeters on a scale
6.58
(-5.65 to 18.81)
2.16
(-8.40 to 12.71)
12.Secondary Outcome
Title Clinical Global Impression - Global Improvement (CGI-I) Scale
Hide Description Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome.
Time Frame Values of the Termination visit (4 weeks + 2 days from baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.95  (0.71) 4.42  (0.61)
13.Secondary Outcome
Title Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.
Hide Description

Safety and tolerability will be evaluated with reference to the following:

Number of subjects (%) who discontinue the study Number of subjects (%) who discontinue the study due to AE Adverse Events (AE): total number of patients with all adverse events is reported (no reporting threshold)
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Measure Type: Count of Participants
Unit of Measure: Participants
Number of subjects who discontinue the study
0
   0.0%
0
   0.0%
Number of subjects who discontinue due to AEs
0
   0.0%
0
   0.0%
Total number of patients with Adverse Events
6
  31.6%
8
  42.1%
14.Secondary Outcome
Title Suicidality in PD Patients Taking Nabilone.
Hide Description

Assessment of aggregated data (suicidality present / no suicidality) of the Columbia-Suicide Severity Rating Scale (C-SSRS). The scale consists of questions for suicidality that can be answered with either "yes" or "no". The answer "no" indicates no wish to be dead, no suicidal ideations, or suicidal attempts.

No minimum or maximum score values can be provided. The values provided represent the number of patients with (new) suicidality.
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Change in Hallucinations in PD Patients Taking Nabilone
Hide Description Number of patients with changes in the points of the Hallucination item (1.2) of the Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).
Time Frame from baseline to 4 weeks + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Orthostatic Hypotension in PD Patients Taking Nabilone
Hide Description Changes in points of the Orthostatic hypotension (OH) item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS), minimum of 0, maximum of 4 points, higher score values representing a worse outcome.
Time Frame from baseline to week 4 + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
0.21
(-0.13 to 0.55)
-0.26
(-0.65 to 0.13)
17.Secondary Outcome
Title Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS
Hide Description Changes in points of the Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) , minimum of 0, maximum of 4 points, higher score values representing a worse outcome
Time Frame from baseline to week 4 + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
0.26
(-0.01 to 0.53)
0.11
(-0.21 to 0.42)
18.Secondary Outcome
Title Subject Incompliance in PD Patients Taking Nabilone
Hide Description subject incompliance as per drug accountability.
Time Frame from baseline to week 4 + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Weight (kg) in PD Patients Taking Nabilone.
Hide Description changes in weight (kg)
Time Frame from baseline to week 4 + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: kg
-0.70  (2.33) -0.52  (2.37)
20.Secondary Outcome
Title Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.
Hide Description changes in temperature (degree Celsius)
Time Frame from baseline to week 4 + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: degree Celsius
0.17  (0.56) 0.35  (0.48)
21.Secondary Outcome
Title Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.
Hide Description

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 the baseline visit
  2. Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the week 4 - visit
  3. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the baseline visit
  4. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the week 4 - visit
Time Frame values from baseline and week 4 + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline: Change supine - 3 min standing, SBP 1.47  (13.88) -4.05  (11.53)
week4: Change supine - 3 min standing, SBP -1.84  (10.68) -2.95  (17.96)
Baseline: Change supine - 3 min standing, DBP 3.79  (5.84) 3.16  (6.07)
week4: Change supine - 3 min standing, DBP 4.11  (5.95) -0.79  (7.90)
22.Secondary Outcome
Title Changes in Quality of Life of PD
Hide Description Parkinson´s Disease Questionnaire - 39 (PDQ-39) Minimum: 0, maximum: 156, higher score values indicate a worse outcome. Values were standardized = PDQ-39 Summary Index (SI, the score of each subdomain was divided by the number of questions of that domain and then multiplied by hundred, the sum score is the sum of the results of all 8 domains)
Time Frame from baseline to week 4 + 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
PDQ-39 SI values reported
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
Overall Number of Participants Analyzed 19 19
Mean (90% Confidence Interval)
Unit of Measure: units on a scale
-0.49
(-3.04 to 2.05)
-0.47
(-3.21 to 2.28)
23.Other Pre-specified Outcome
Title The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo.
Hide Description Change of the reaction time (seconds) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.
Time Frame Maximum of 104 days
Outcome Measure Data Not Reported
24.Other Pre-specified Outcome
Title The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo.
Hide Description Change of attention span and ability to concentrate (error rate, correct trials) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.
Time Frame Maximum of 104 days
Outcome Measure Data Not Reported
Time Frame Each patient was assessed from first intake of study drug to study discontinuation.
Adverse Event Reporting Description definitions do not differ
 
Arm/Group Title Treatment Group (Open-label Phase) Treatment Group (Double-blind Phase) Placebo Group (Double-blind Phase)
Hide Arm/Group Description

Nabilone 0.25 mg

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

Nabilone 0.25 mg

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

Placebo (corn starch)

Placebo: capsule, corn starch, daily basis
All-Cause Mortality
Treatment Group (Open-label Phase) Treatment Group (Double-blind Phase) Placebo Group (Double-blind Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)      0/19 (0.00%)      0/19 (0.00%)    
Hide Serious Adverse Events
Treatment Group (Open-label Phase) Treatment Group (Double-blind Phase) Placebo Group (Double-blind Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/47 (0.00%)      0/19 (0.00%)      0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group (Open-label Phase) Treatment Group (Double-blind Phase) Placebo Group (Double-blind Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/47 (63.83%)      4/19 (21.05%)      9/19 (47.37%)    
Infections and infestations       
Upper respiratory tract infection *  4/47 (8.51%)  5 0/19 (0.00%)  0 3/19 (15.79%)  3
Musculoskeletal and connective tissue disorders       
Pain (including worsening) *  4/47 (8.51%)  4 1/19 (5.26%)  1 2/19 (10.53%)  2
Fall (including recurrent falls) *  2/47 (4.26%)  2 1/19 (5.26%)  1 1/19 (5.26%)  1
Nervous system disorders       
Insomnia *  0/47 (0.00%)  0 2/19 (10.53%)  2 2/19 (10.53%)  2
Syncope *  0/47 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  2
Fatigue *  13/47 (27.66%)  17 0/19 (0.00%)  0 0/19 (0.00%)  0
Dizziness *  9/47 (19.15%)  9 0/19 (0.00%)  0 0/19 (0.00%)  0
Daytime sleepiness *  4/47 (8.51%)  5 0/19 (0.00%)  0 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dry mouth *  4/47 (8.51%)  4 0/19 (0.00%)  0 0/19 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
negative expectations might impact results (due to withdrawal design), sample size of 38 patients (double-blind phase), all caucasian patients
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Klaus Seppi
Organization: Medical University of Innsbruck
Phone: 004351250481553
EMail: klaus.seppi@tirol-kliniken.at
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Klaus Seppi, MD, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03769896    
Other Study ID Numbers: 1.4
First Submitted: December 6, 2018
First Posted: December 10, 2018
Results First Submitted: August 22, 2020
Results First Posted: March 2, 2021
Last Update Posted: March 2, 2021