Parkinson Disease
Conditions
Keywords
Parkinson´s Disease, cannabinoids, non-motor symptoms
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.
Interventions
DRUGNabilone 0.25 mg
capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
Sponsors
Medical University Innsbruck
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
None, open-label
Intervention model description
open-label
Eligibility
Sex/Gender
ALL
Age
30 Years to 100 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Day-time Sleepiness in PD Patients Taking Nabilone Between V 1 and V 3 | between V 1 and V 3 (6 months) | 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. |
| Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3 | between V 1 and V 3 (6 months) | 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 |
| Orthostatic Hypotension in PD Patients Taking Nabilone Between V 1 and V 3 | between V 1 and V 3 (6 months) | 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. |
| AEs in PD Patients Taking Nabilone, Between V 1 and V 3 | 6 months | Safety and tolerability will be evaluated with reference to the following: Adverse Events (AE) |
| Number of Subjects (%) Who Discontinue the Study Due to an AE Between V 1 and V 3 | 6 months | 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. |
| Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3 | 6 months | 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. |
| Subject Compliance in PD Patients Taking Nabilone. | between V 1 and V 3 (6 months) | subject incompliance as per drug accountability (%) |
| Suicidality in PD Patients Taking Nabilone Between V 1 and V 3 Using the Columbia-Suicide Severity Rating Scale | between V 1 and V 3 (6 months) | 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. |
| Hallucinations in PD Patients Taking Nabilone Between V 1 and V 3 | between V 1 and V 3 (6 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cognitive Function (MoCA) in Patients With PD Taking Nabilone Between V 1 and V 3 | from Screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion) | The change of Montreal Cognitive Assessment (MoCA, minimum 0 points, maximum 30 points, higher score values indicate better outcome) score values between the Screening Visit of the NMS-Nab Study (before the first intake of nabilone medication) and the termination visit of this study will be assessed as secondary efficacy endpoints. |
| Changes in Cognitive Function (MMSE) in Patients With PD Taking Nabilone | from screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion) | The change of Mini Mental State Exam (MMSE, minimum 0 points, maximum 30 points, higher score values indicate better outcome) between the Screening Visit of the NMS-Nab Study (before the first intake of nabilone medication) and the termination visit of this study will be assessed as secondary efficacy endpoints. |
| Changes in Overall Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3 | between V 1 and V 3 (6 months) | Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Clinical Global Impression - Global Improvement (CGI-I) Minimum: 1, maximum: 7, higher score values indicate a worse outcome. |
| 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) | Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Total and different parts of 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. 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. Part IV: minimum points: 0, maximum points: 24, higher score values indicate a worse outcome. Total Score: minimum points: 0, maximum points: 272, higher score values indicate a worse outcome. |
| 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) | Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome. |
| 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) | Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Hospital anxiety and depression scale (HADS), HADS-A assesses anxiety, HADS-D depression. Total scale: minimum: 0, maximum: 42, separate HADS-A/-D score: minimum: 0, maximum: 21. Higher score values indicate a worse outcome. |
| 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) | Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Parkinson´s Disease Questionnaire - 8 (PDQ-8). Minimum: 0, maximum: 42, higher score values indicate a worse outcome. PDQ-8 was standardized, therefore the score ranges from 0 to 100 (= PDQ-8 Summary Index). |
| Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3 | between V 1 and V 3 (6 months) | Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome. |
| Changes in Fatigue in Patients With PD Taking Nabilone Between V 1 and V 3 | between V 1 and V 3 (6 months) | Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Fatigue Severity Scale (FSS). Minimum: 9, maximum: 63, higher score values indicate a worse outcome. |
| Changes in Pain in Patients With PD Taking Nabilone Between V 1 and V 3 | between V 1 and V 3 (6 months) | Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome. |
| Changes in Impulsive-compulsive Behaviour in Patients With PD Taking Nabilone Between V 1 and V 3 | between V 1 and V 3 (6 months) | Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | Change of the reaction time (seconds), between Screening and Termination Visit of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study and V 2 of this study as measured by the Eye-tracking examination. |
| 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 | Change of ability to concentrate (error rate, correct trials) between Screening and Termination Visit of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study and V 2 of this study as measured by the Eye-tracking examination. |
| 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 | Change of attention span (error rate, correct trials) between Screening and Termination Visit of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study and V 2 of this study as measured by the Eye-tracking examination. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg
Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 67.23 years STANDARD_DEVIATION 6.15 |
| Disease duration | 9.30 years STANDARD_DEVIATION 6.04 |
| Education | 12.81 years STANDARD_DEVIATION 2.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 11 / 22 |
| serious Total, serious adverse events | 4 / 22 |
Outcome results
Primary
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)
Time frame: 6 months
Population: primary endpoint was safety, please refer to Adverse events section.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | AEs in PD Patients Taking Nabilone, Between V 1 and V 3 | 39 adverse events |
Primary
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
Time frame: between V 1 and V 3 (6 months)
Population: 21 patients for V 1 and 19 for V 3 analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3 | 1. change of SBP from supine to standing position for 3 min at V 1 | 5.14 mmHg | Standard Deviation 7.15 |
| Treatment Group | Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3 | 2. change of SBP from supine to standing position for 3 min at V 3 | 6.05 mmHg | Standard Deviation 11.4 |
| Treatment Group | Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3 | 3. change of DBP from supine to standing position for 3 min at V 1 | 0.76 mmHg | Standard Deviation 6.96 |
| Treatment Group | Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3 | 4. change of DBP from supine to standing position for 3 min at V 3 | -0.42 mmHg | Standard Deviation 9.05 |
Primary
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.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Day-time Sleepiness in PD Patients Taking Nabilone Between V 1 and V 3 | -0.05 units on a scale | Standard Deviation 0.83 |
Primary
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.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Hallucinations in PD Patients Taking Nabilone Between V 1 and V 3 | less hallucinations | 1 Participants |
| Treatment Group | Hallucinations in PD Patients Taking Nabilone Between V 1 and V 3 | more hallucinations | 0 Participants |
| Treatment Group | Hallucinations in PD Patients Taking Nabilone Between V 1 and V 3 | no change | 18 Participants |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Subjects (%) Who Discontinue the Study Due to an AE Between V 1 and V 3 | 1 Participants |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3 | 1 Participants |
Primary
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.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Orthostatic Hypotension in PD Patients Taking Nabilone Between V 1 and V 3 | -0.16 units on a scale | Standard Deviation 0.77 |
Primary
Subject Compliance in PD Patients Taking Nabilone.
subject incompliance as per drug accountability (%)
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Subject Compliance in PD Patients Taking Nabilone. | 0 Participants |
Primary
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.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Suicidality in PD Patients Taking Nabilone Between V 1 and V 3 Using the Columbia-Suicide Severity Rating Scale | 0 Participants |
Secondary
Changes in Cognitive Function (MMSE) in Patients With PD Taking Nabilone
The change of Mini Mental State Exam (MMSE, minimum 0 points, maximum 30 points, higher score values indicate better outcome) between the Screening Visit of the NMS-Nab Study (before the first intake of nabilone medication) and the termination visit of this study will be assessed as secondary efficacy endpoints.
Time frame: from screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Changes in Cognitive Function (MMSE) in Patients With PD Taking Nabilone | 0.42 units on a scale | Standard Deviation 1.84 |
Secondary
Changes in Cognitive Function (MoCA) in Patients With PD Taking Nabilone Between V 1 and V 3
The change of Montreal Cognitive Assessment (MoCA, minimum 0 points, maximum 30 points, higher score values indicate better outcome) score values between the Screening Visit of the NMS-Nab Study (before the first intake of nabilone medication) and the termination visit of this study will be assessed as secondary efficacy endpoints.
Time frame: from Screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Changes in Cognitive Function (MoCA) in Patients With PD Taking Nabilone Between V 1 and V 3 | -0.11 units on a scale | Standard Deviation 1.94 |
Secondary
Changes in Fatigue in Patients With PD Taking Nabilone Between V 1 and V 3
Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Fatigue Severity Scale (FSS). Minimum: 9, maximum: 63, higher score values indicate a worse outcome.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Changes in Fatigue in Patients With PD Taking Nabilone Between V 1 and V 3 | 4.26 units on a scale | Standard Deviation 10.08 |
Secondary
Changes in Impulsive-compulsive Behaviour in Patients With PD Taking Nabilone Between V 1 and V 3
Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: 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: between V 1 and V 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Changes in Impulsive-compulsive Behaviour in Patients With PD Taking Nabilone Between V 1 and V 3 | 0.11 units on a scale | Standard Deviation 1.41 |
Secondary
Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3
Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Total and different parts of 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. 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. Part IV: minimum points: 0, maximum points: 24, higher score values indicate a worse outcome. Total Score: minimum points: 0, maximum points: 272, higher score values indicate a worse outcome.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3 | MDS-UPDRS I | 1.58 units on a scale | Standard Deviation 13.87 |
| Treatment Group | Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3 | MDS-UPDRS II | -0.58 units on a scale | Standard Deviation 3.49 |
| Treatment Group | Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3 | MDS-UPDRS III | -1.89 units on a scale | Standard Deviation 6.88 |
| Treatment Group | Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3 | MDS-UPDRS IV | -0.16 units on a scale | Standard Deviation 2.14 |
| Treatment Group | Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3 | MDS-UPDRS Total Score | -1.05 units on a scale | Standard Deviation 15.9 |
Secondary
Changes in Non-motor Symptoms (HADS) in Patients With PD Taking Nabilone Between V 1 and V 3
Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Hospital anxiety and depression scale (HADS), HADS-A assesses anxiety, HADS-D depression. Total scale: minimum: 0, maximum: 42, separate HADS-A/-D score: minimum: 0, maximum: 21. Higher score values indicate a worse outcome.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Changes in Non-motor Symptoms (HADS) in Patients With PD Taking Nabilone Between V 1 and V 3 | HADS-A | -0.16 units on a scale | Standard Deviation 1.3 |
| Treatment Group | Changes in Non-motor Symptoms (HADS) in Patients With PD Taking Nabilone Between V 1 and V 3 | HADS-D | 1.00 units on a scale | Standard Deviation 2.08 |
Secondary
Changes in Non-motor Symptoms (NMSS) in Patients With PD Taking Nabilone Between V 1 and V 3
Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Changes in Non-motor Symptoms (NMSS) in Patients With PD Taking Nabilone Between V 1 and V 3 | -4.84 units on a scale | Standard Deviation 18.08 |
Secondary
Changes in Overall Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3
Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Clinical Global Impression - Global Improvement (CGI-I) Minimum: 1, maximum: 7, higher score values indicate a worse outcome.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Changes in Overall Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3 | -1.16 units on a scale | Standard Deviation 1.3 |
Secondary
Changes in Pain in Patients With PD Taking Nabilone Between V 1 and V 3
Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Changes in Pain in Patients With PD Taking Nabilone Between V 1 and V 3 | -6.84 units on a scale | Standard Deviation 15.12 |
Secondary
Changes in Quality of Life in Patients With PD Taking Nabilone Between V 1 and V 3
Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Parkinson´s Disease Questionnaire - 8 (PDQ-8). Minimum: 0, maximum: 42, higher score values indicate a worse outcome. PDQ-8 was standardized, therefore the score ranges from 0 to 100 (= PDQ-8 Summary Index).
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Changes in Quality of Life in Patients With PD Taking Nabilone Between V 1 and V 3 | -2.96 units on a scale | Standard Deviation 9.11 |
Secondary
Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3
Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes in points from V 1 to the termination visit in the following questionnaires: Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome.
Time frame: between V 1 and V 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3 | 0.11 units on a scale | Standard Deviation 2.75 |
Other Pre-specified
Eye-tracking Evaluation in PD Patients Taking Nabilone at Visit V 2 to Assess Changes in Attention Span.
Change of attention span (error rate, correct trials) between Screening and Termination Visit of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study and V 2 of this study as measured by the Eye-tracking examination.
Time frame: a maximum of 2 years, measurement at V2 visit
Other Pre-specified
Eye-tracking Evaluation in PD Patients Taking Nabilone at Visit V 2 to Assess Changes in Reaction Time.
Change of the reaction time (seconds), between Screening and Termination Visit of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study and V 2 of this study as measured by the Eye-tracking examination.
Time frame: a maximum of 2 years, measurement at V2 visit
Other Pre-specified
Eye-tracking Evaluation in PD Patients Taking Nabilone at Visit V 2 to Assess Changes in the Ability to Concentrate.
Change of ability to concentrate (error rate, correct trials) between Screening and Termination Visit of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study and V 2 of this study as measured by the Eye-tracking examination.
Time frame: a maximum of 2 years, measurement at V2 visit