Trial Outcomes & Findings for Nabilone for Non-motor Symptoms in Parkinson's Disease (NCT NCT03769896)
NCT ID: NCT03769896
Last Updated: 2021-03-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
from baseline to 4 weeks + 2 days
Results posted on
2021-03-02
Participant Flow
location: Medical Clinic, period: October 2017 to July 2019
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.
Participant milestones
| Measure |
Treatment Group
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 Group
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Open-label Phase
STARTED
|
47
|
0
|
|
Open-label Phase
COMPLETED
|
38
|
0
|
|
Open-label Phase
NOT COMPLETED
|
9
|
0
|
|
Double-blind Treatment Phase
STARTED
|
19
|
19
|
|
Double-blind Treatment Phase
COMPLETED
|
19
|
19
|
|
Double-blind Treatment Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Group
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 Group
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Open-label Phase
Lack of Efficacy
|
5
|
0
|
|
Open-label Phase
Adverse Event
|
3
|
0
|
|
Open-label Phase
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Nabilone for Non-motor Symptoms in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.38 years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
63.95 years
STANDARD_DEVIATION 8.04 • n=7 Participants
|
65.05 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
00 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Disease duration
|
7.83 years
STANDARD_DEVIATION 5.47 • n=5 Participants
|
7.39 years
STANDARD_DEVIATION 5.14 • n=7 Participants
|
7.61 years
STANDARD_DEVIATION 5.24 • n=5 Participants
|
|
Hoehn and Yahr Scale
|
1.84 units on a scale
STANDARD_DEVIATION 0.50 • n=5 Participants
|
1.95 units on a scale
STANDARD_DEVIATION 0.41 • n=7 Participants
|
1.89 units on a scale
STANDARD_DEVIATION 0.45 • n=5 Participants
|
|
MDS-UPDRS Total Score
|
52.05 units on a scale
STANDARD_DEVIATION 22.97 • n=5 Participants
|
52.05 units on a scale
STANDARD_DEVIATION 14.75 • n=7 Participants
|
52.05 units on a scale
STANDARD_DEVIATION 19.04 • n=5 Participants
|
|
MDS-UPDRS-I
|
13.53 units on a scale
STANDARD_DEVIATION 4.39 • n=5 Participants
|
12.26 units on a scale
STANDARD_DEVIATION 5.85 • n=7 Participants
|
12.89 units on a scale
STANDARD_DEVIATION 5.14 • n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline to 4 weeks + 2 daysChanges 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.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes of Non-motor Symptoms
|
1.00 units on a scale
Interval -0.16 to 2.16
|
2.63 units on a scale
Interval 1.53 to 3.74
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysChanges 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.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Motor and Different Non-motor Symptoms of PD
MDS-UPDRS II
|
0.47 units on a scale
Interval -0.37 to 1.31
|
0.90 units on a scale
Interval -0.35 to 2.14
|
|
Changes in Motor and Different Non-motor Symptoms of PD
MDS-UPDRS III
|
0.53 units on a scale
Interval -2.24 to 3.29
|
2.63 units on a scale
Interval 0.25 to 5.02
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysmood/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.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Different Domains of Non-motor Symptoms of PD
MDS-UPDRS 1.3 Depressed Mood
|
0.11 units on a scale
Interval -0.17 to 0.38
|
0.16 units on a scale
Interval -0.08 to 0.4
|
|
Changes in Different Domains of Non-motor Symptoms of PD
MDS-UPDRS 1.4 Anxious Mood
|
-0.16 units on a scale
Interval -0.53 to 0.21
|
0.21 units on a scale
Interval -0.05 to 0.47
|
|
Changes in Different Domains of Non-motor Symptoms of PD
MDS-UPDRS 1.7 Nighttime sleep problems
|
0.05 units on a scale
Interval -0.47 to 0.57
|
1.79 units on a scale
Interval 1.15 to 2.42
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysNon Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Non-motor Symptoms of PD
|
4.05 score on a scale
Interval -0.65 to 8.75
|
11.00 score on a scale
Interval 4.68 to 17.32
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysHospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Non-motor Symptoms of PD
Hospital anxiety and depression scale - Anxiety
|
0.26 units on a scale
Interval -0.87 to 1.4
|
0.05 units on a scale
Interval -1.09 to 1.19
|
|
Changes in Non-motor Symptoms of PD
Hospital anxiety and depression scale - Depression
|
0.32 units on a scale
Interval -1.11 to 1.74
|
0.16 units on a scale
Interval -0.71 to 1.03
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysEpworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Non-motor Symptoms of PD
|
-0.74 units on a scale
Interval -1.87 to 0.4
|
-0.79 units on a scale
Interval -1.85 to 0.27
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysFatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Non-motor Symptoms of PD
|
-4.00 units on a scale
Interval -9.77 to 1.77
|
0.00 units on a scale
Interval -5.26 to 5.26
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysKing's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Non-motor Symptoms of PD
|
1.58 units on a scale
Interval -2.73 to 5.89
|
2.84 units on a scale
Interval -5.19 to 10.87
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysQuestionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Non-motor Symptoms of PD
|
-0.68 units on a scale
Interval -1.49 to 0.12
|
0.05 units on a scale
Interval -0.64 to 0.74
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysMontreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Non-motor Symptoms of PD
|
0.74 units on a scale
Interval -0.18 to 1.66
|
0.00 units on a scale
Interval -0.63 to 0.62
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysVisual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Non-motor Symptoms of PD
|
6.58 millimeters on a scale
Interval -5.65 to 18.81
|
2.16 millimeters on a scale
Interval -8.4 to 12.71
|
SECONDARY outcome
Timeframe: Values of the Termination visit (4 weeks + 2 days from baseline)Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Clinical Global Impression - Global Improvement (CGI-I) Scale
|
4.95 units on a scale
Standard Deviation 0.71
|
4.42 units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysSafety 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)
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.
Number of subjects who discontinue the study
|
0 Participants
|
0 Participants
|
|
Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.
Number of subjects who discontinue due to AEs
|
0 Participants
|
0 Participants
|
|
Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.
Total number of patients with Adverse Events
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysAssessment 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.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Suicidality in PD Patients Taking Nabilone.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from baseline to 4 weeks + 2 daysNumber 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).
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Change in Hallucinations in PD Patients Taking Nabilone
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from baseline to week 4 + 2 daysChanges 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.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Orthostatic Hypotension in PD Patients Taking Nabilone
|
0.21 units on a scale
Interval -0.13 to 0.55
|
-0.26 units on a scale
Interval -0.65 to 0.13
|
SECONDARY outcome
Timeframe: from baseline to week 4 + 2 daysChanges 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
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS
|
0.26 units on a scale
Interval -0.01 to 0.53
|
0.11 units on a scale
Interval -0.21 to 0.42
|
SECONDARY outcome
Timeframe: from baseline to week 4 + 2 dayssubject incompliance as per drug accountability.
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Subject Incompliance in PD Patients Taking Nabilone
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from baseline to week 4 + 2 dayschanges in weight (kg)
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Weight (kg) in PD Patients Taking Nabilone.
|
-0.70 kg
Standard Deviation 2.33
|
-0.52 kg
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: from baseline to week 4 + 2 dayschanges in temperature (degree Celsius)
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.
|
0.17 degree Celsius
Standard Deviation 0.56
|
0.35 degree Celsius
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: values from baseline and week 4 + 2 dayschanges 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
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.
Baseline: Change supine - 3 min standing, SBP
|
1.47 mmHg
Standard Deviation 13.88
|
-4.05 mmHg
Standard Deviation 11.53
|
|
Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.
week4: Change supine - 3 min standing, SBP
|
-1.84 mmHg
Standard Deviation 10.68
|
-2.95 mmHg
Standard Deviation 17.96
|
|
Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.
Baseline: Change supine - 3 min standing, DBP
|
3.79 mmHg
Standard Deviation 5.84
|
3.16 mmHg
Standard Deviation 6.07
|
|
Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.
week4: Change supine - 3 min standing, DBP
|
4.11 mmHg
Standard Deviation 5.95
|
-0.79 mmHg
Standard Deviation 7.90
|
SECONDARY outcome
Timeframe: from baseline to week 4 + 2 daysPopulation: PDQ-39 SI values reported
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)
Outcome measures
| Measure |
Treatment Group
n=19 Participants
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 Group
n=19 Participants
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|
|
Changes in Quality of Life of PD
|
-0.49 units on a scale
Interval -3.04 to 2.05
|
-0.47 units on a scale
Interval -3.21 to 2.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Maximum of 104 daysChange of the reaction time (seconds) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Maximum of 104 daysChange 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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Group (Open-label Phase)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Treatment Group (Double-blind Phase)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Group (Double-blind Phase)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group (Open-label Phase)
n=47 participants at risk
Nabilone 0.25 mg
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
|
Treatment Group (Double-blind Phase)
n=19 participants at risk
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 Group (Double-blind Phase)
n=19 participants at risk
Placebo (corn starch)
Placebo: capsule, corn starch, daily basis
|
|---|---|---|---|
|
Nervous system disorders
Insomnia
|
0.00%
0/47 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
10.5%
2/19 • Number of events 2 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
10.5%
2/19 • Number of events 2 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
|
Infections and infestations
Upper respiratory tract infection
|
8.5%
4/47 • Number of events 5 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
15.8%
3/19 • Number of events 3 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Pain (including worsening)
|
8.5%
4/47 • Number of events 4 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
5.3%
1/19 • Number of events 1 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
10.5%
2/19 • Number of events 2 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
|
Musculoskeletal and connective tissue disorders
Fall (including recurrent falls)
|
4.3%
2/47 • Number of events 2 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
5.3%
1/19 • Number of events 1 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
5.3%
1/19 • Number of events 1 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
|
Nervous system disorders
Syncope
|
0.00%
0/47 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
5.3%
1/19 • Number of events 2 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
|
Nervous system disorders
Fatigue
|
27.7%
13/47 • Number of events 17 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
|
Nervous system disorders
Dizziness
|
19.1%
9/47 • Number of events 9 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
|
Skin and subcutaneous tissue disorders
Dry mouth
|
8.5%
4/47 • Number of events 4 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
|
Nervous system disorders
Daytime sleepiness
|
8.5%
4/47 • Number of events 5 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
0.00%
0/19 • Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place