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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Other | Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nabilone 0.25 mg | Drug | capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | between V 1 and V 3 (6 months) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | a maximum of 2 years, measurement at V2 visit |
Inclusion Criteria:
In order to be eligible for participation in the study, subjects must meet all inclusion criteria:
Exclusion Criteria:
Patients with any of the following characteristics will be excluded from entering the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology - Medical University Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
The results of this study will be published according to the principles of publication policy. There are no arrangements on publication issues with subsiding parties.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Summaries of baseline values were produced in patients receiving at least one dose of study medication and completing at least V 1 as per protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | primary endpoint was safety, please refer to Adverse events section. | Posted | Number | adverse events | 6 months |
|
|
V1 to V 3, 6 months
definitions do not differ
Other Adverse Events: This section only covers adverse events that fulfill the following reporting definition (threshold 5%): Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold (for example, 5%) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rectum carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Klaus Seppi | Medical University of Innsbruck | 004351250481553 | klaus.seppi@tirol-kliniken.at |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2019 | Jan 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C011941 | nabilone |
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open-label
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None, open-label
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| between V 1 and V 3 (6 months) |
| 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. | between V 1 and V 3 (6 months) |
| 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. | between V 1 and V 3 (6 months) |
| Subject Compliance in PD Patients Taking Nabilone. | subject incompliance as per drug accountability (%) | between V 1 and V 3 (6 months) |
| 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:
| between V 1 and V 3 (6 months) |
| between V 1 and V 3 (6 months) |
| 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. | between V 1 and V 3 (6 months) |
| 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. | between V 1 and V 3 (6 months) |
| 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). | between V 1 and V 3 (6 months) |
| 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. | between V 1 and V 3 (6 months) |
| 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. | between V 1 and V 3 (6 months) |
| 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. | between V 1 and V 3 (6 months) |
| 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. | between V 1 and V 3 (6 months) |
| 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. | between V 1 and V 3 (6 months) |
| 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. | from Screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion) |
| 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. | from screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion) |
| 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. | a maximum of 2 years, measurement at V2 visit |
| 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. | a maximum of 2 years, measurement at V2 visit |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Disease duration | Mean | Standard Deviation | years |
|
| Education | Mean | Standard Deviation | years |
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Count of Participants | Participants | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| Primary | Subject Compliance in PD Patients Taking Nabilone. | subject incompliance as per drug accountability (%) | Posted | Count of Participants | Participants | between V 1 and V 3 (6 months) |
|
|
|
| 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:
| 21 patients for V 1 and 19 for V 3 analyzed. | Posted | Mean | Standard Deviation | mmHg | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | between V 1 and V 3 (6 months) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | from Screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | from screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion) |
|
|
|
| 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. | Not Posted | a maximum of 2 years, measurement at V2 visit | Participants |
| 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. | Not Posted | a maximum of 2 years, measurement at V2 visit | Participants |
| 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. | Not Posted | a maximum of 2 years, measurement at V2 visit | Participants |
| 0 |
| 22 |
| 4 |
| 22 |
| 11 |
| 22 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Worsening of Parkinson´s disease symptoms | Nervous system disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment | hospitalization due to medication-induced nausea and vomiting |
|
| Concentration difficulties | Nervous system disorders | Systematic Assessment |
|
| intermittant falls | Nervous system disorders | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| transient numbness of the face | Nervous system disorders | Systematic Assessment |
|
| Osteopenia | Metabolism and nutrition disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Worsening of Parkinson´s Disease symptoms | Nervous system disorders | Systematic Assessment |
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| Osteoarthropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
|
| 4. change of DBP from supine to standing position for 3 min at V 3 |
|
| Title | Measurements |
|---|---|
|
| MDS-UPDRS IV |
|
| MDS-UPDRS Total Score |
|