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This is a randomized placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal study assessing the efficacy and safety of nabilone for non-motor symptoms in patients with Parkinson´s Disease. 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.
Part 1 is an open-label dose adjustment phase of the study. In eligible patients, a screening period is followed by an open-label nabilone dose optimization phase and a stable phase for at least 1 week. Treatment responders will be included in Part 2 of the study (randomized placebo-controlled, double-blind, parallel-grouped).
Part 2 is the placebo-controlled, double-blind, parallel-group randomized withdrawal phase of the study.
This is a randomized placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal study assessing the efficacy and safety of nabilone for non-motor symptoms in patients with Parkinson´s Disease. 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.
Part 1 is the open-label dose adjustment phase of the study. In Part 1, eligible subjects, who have signed the informed consent form at the screening visit, will receive open-label nabilone starting with a dosage of 0.25 mg in the evening. During dose titration and optimization, nabilone will be titrated in 0.25 mg increments (increase by 0.25 mg/ every one to four days) up to a maximum dose of 1 mg twice daily. Patients should be on a stable nabilone dose for at least 1 week afterwards until Baseline Visit (V 0).
Part 2 is the placebo-controlled, double-blind, parallel-group randomized withdrawal phase of the study. At Baseline Visit, treatment responders will be included in Part 2 of the study (randomized placebo-controlled, double-blind, parallel-grouped). Responders are randomized in a 1:1 ratio at Baseline Visit to receive either nabilone or matching placebo for 4 weeks + 2 days. The placebo-controlled, double-blind, randomized withdrawal phase will end with a clinic visit (Termination Visit V 1). Following this, the study medication will be tapered in all patients. During this period the patients will receive phone calls every other day. A Safety Telephone Call and a Safety Follow-Up Visit will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | Nabilone 0.25 mg |
|
| Placebo Group | Placebo Comparator | Placebo (corn starch) |
|
| 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 |
|---|---|---|
| Changes of Non-motor Symptoms | 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. | from baseline to 4 weeks + 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Motor and Different Non-motor Symptoms of PD | 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. | from baseline to 4 weeks + 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo. | 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. | Maximum of 104 days |
| The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo. |
Inclusion Criteria:
In order to be eligible for the study subjects must meet all inclusion criteria:
Age ≥30 years
Diagnosis of Parkinson´s Disease (PD): PD should be either de novo or on stable medication without disturbing motor fluctuations or dyskinesia.
NMS with a score of ≥4 on MDS-UPDRS Part 1. One of the following domains have to be affected with a score ≥2: 1.4 (anxious mood) or 1.9 (pain)
On a stable regimen of anti-parkinson medications for at least 30 days prior to screening and willing to continue the same doses and regimens during study participation
Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation
Patient is informed and had enough time and opportunity to think about his/her participation in the study and has signed a current Institutional Review Board-approved informed consent form
Contraception
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35937495 | Derived | Peball M, Seppi K, Krismer F, Knaus HG, Spielberger S, Heim B, Ellmerer P, Werkmann M, Poewe W, Djamshidian A. Effects of Nabilone on Sleep Outcomes in Patients with Parkinson's Disease: A Post-hoc Analysis of NMS-Nab Study. Mov Disord Clin Pract. 2022 May 31;9(6):751-758. doi: 10.1002/mdc3.13471. eCollection 2022 Aug. | |
| 32757413 |
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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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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.
location: Medical Clinic, period: October 2017 to July 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo Group | Placebo (corn starch) Placebo: capsule, corn starch, daily basis |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open-label Phase |
|
| |||||||||||||||||||||
| Double-blind Treatment Phase |
|
baseline characteristics (as assessed at the screening visit) for the 38 randomized patients
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo Group | Placebo (corn starch) Placebo: capsule, corn starch, 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 | Changes of Non-motor Symptoms | 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. | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to 4 weeks + 2 days |
|
Each patient was assessed from first intake of study drug to study discontinuation.
definitions do not differ
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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 (Open-label Phase) | Nabilone 0.25 mg Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | Non-systematic Assessment |
negative expectations might impact results (due to withdrawal design), sample size of 38 patients (double-blind phase), all caucasian patients
| 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 8, 2018 | Aug 22, 2020 | 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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randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study
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placebo-controlled, double-blind, parallel-group with 1 : 1 randomization
| Placebo | Drug | capsule, corn starch, daily basis |
|
| Changes in Different Domains of Non-motor Symptoms of PD | 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. | from baseline to 4 weeks + 2 days |
| Changes in Non-motor Symptoms of PD | Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome. | from baseline to 4 weeks + 2 days |
| Changes in Non-motor Symptoms of PD | Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome. | from baseline to 4 weeks + 2 days |
| Changes in Non-motor Symptoms of PD | Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome. | from baseline to 4 weeks + 2 days |
| Changes in Non-motor Symptoms of PD | Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome. | from baseline to 4 weeks + 2 days |
| Changes in Non-motor Symptoms of PD | King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome. | from baseline to 4 weeks + 2 days |
| Changes in Non-motor Symptoms of PD | Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome. | from baseline to 4 weeks + 2 days |
| Changes in Non-motor Symptoms of PD | Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome. | from baseline to 4 weeks + 2 days |
| Changes in Non-motor Symptoms of PD | Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome. | from baseline to 4 weeks + 2 days |
| Clinical Global Impression - Global Improvement (CGI-I) Scale | Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome. | Values of the Termination visit (4 weeks + 2 days from baseline) |
| Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone. | 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) | from baseline to 4 weeks + 2 days |
| Suicidality in PD Patients Taking Nabilone. | 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. | from baseline to 4 weeks + 2 days |
| Change in Hallucinations in PD Patients Taking Nabilone | 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). | from baseline to 4 weeks + 2 days |
| Orthostatic Hypotension in PD Patients Taking Nabilone | 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. | from baseline to week 4 + 2 days |
| Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS | 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 | from baseline to week 4 + 2 days |
| Subject Incompliance in PD Patients Taking Nabilone | subject incompliance as per drug accountability. | from baseline to week 4 + 2 days |
| Weight (kg) in PD Patients Taking Nabilone. | changes in weight (kg) | from baseline to week 4 + 2 days |
| Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone. | changes in temperature (degree Celsius) | from baseline to week 4 + 2 days |
| Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone. | changes in supine and standing blood pressure measurements (mmHg) Row titles:
| values from baseline and week 4 + 2 days |
| Changes in Quality of Life of PD | 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) | from baseline to week 4 + 2 days |
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. |
| Maximum of 104 days |
| Peball M, Krismer F, Knaus HG, Djamshidian A, Werkmann M, Carbone F, Ellmerer P, Heim B, Marini K, Valent D, Goebel G, Ulmer H, Stockner H, Wenning GK, Stolz R, Krejcy K, Poewe W, Seppi K; Collaborators of the Parkinson's Disease Working Group Innsbruck. Non-Motor Symptoms in Parkinson's Disease are Reduced by Nabilone. Ann Neurol. 2020 Oct;88(4):712-722. doi: 10.1002/ana.25864. Epub 2020 Aug 31. |
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease duration | Mean | Standard Deviation | years |
|
| Hoehn and Yahr Scale | Hoehn and Yahr scale:
| Mean | Standard Deviation | units on a scale |
|
| MDS-UPDRS Total Score | Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS)
| Mean | Standard Deviation | units on a scale |
|
| MDS-UPDRS-I | Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part I
| Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Changes in Motor and Different Non-motor Symptoms of PD | 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. | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Changes in Different Domains of Non-motor Symptoms of PD | 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. | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Changes in Non-motor Symptoms of PD | Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome. | Posted | Mean | 90% Confidence Interval | score on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Changes in Non-motor Symptoms of PD | Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome. | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Changes in Non-motor Symptoms of PD | Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome. | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Changes in Non-motor Symptoms of PD | Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome. | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Changes in Non-motor Symptoms of PD | King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome. | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Changes in Non-motor Symptoms of PD | 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 | 90% Confidence Interval | units on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Changes in Non-motor Symptoms of PD | Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome. | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Changes in Non-motor Symptoms of PD | Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome. | Posted | Mean | 90% Confidence Interval | millimeters on a scale | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Clinical Global Impression - Global Improvement (CGI-I) Scale | Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | Values of the Termination visit (4 weeks + 2 days from baseline) |
|
|
|
| Secondary | Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone. | 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) | Posted | Count of Participants | Participants | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Suicidality in PD Patients Taking Nabilone. | 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. | Posted | Count of Participants | Participants | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Change in Hallucinations in PD Patients Taking Nabilone | 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). | Posted | Count of Participants | Participants | from baseline to 4 weeks + 2 days |
|
|
|
| Secondary | Orthostatic Hypotension in PD Patients Taking Nabilone | 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. | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to week 4 + 2 days |
|
|
|
| Secondary | Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS | 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 | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to week 4 + 2 days |
|
|
|
| Secondary | Subject Incompliance in PD Patients Taking Nabilone | subject incompliance as per drug accountability. | Posted | Count of Participants | Participants | from baseline to week 4 + 2 days |
|
|
|
| Secondary | Weight (kg) in PD Patients Taking Nabilone. | changes in weight (kg) | Posted | Mean | Standard Deviation | kg | from baseline to week 4 + 2 days |
|
|
|
| Secondary | Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone. | changes in temperature (degree Celsius) | Posted | Mean | Standard Deviation | degree Celsius | from baseline to week 4 + 2 days |
|
|
|
| Secondary | Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone. | changes in supine and standing blood pressure measurements (mmHg) Row titles:
| Posted | Mean | Standard Deviation | mmHg | values from baseline and week 4 + 2 days |
|
|
|
| Secondary | Changes in Quality of Life of PD | 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) | PDQ-39 SI values reported | Posted | Mean | 90% Confidence Interval | units on a scale | from baseline to week 4 + 2 days |
|
|
|
| Other Pre-specified | The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo. | 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. | Not Posted | Maximum of 104 days | Participants |
| Other Pre-specified | The Exploratory Objective of This Study Will be an Eye-tracking Evaluation in PD Patients Taking Nabilone or Placebo. | 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. | Not Posted | Maximum of 104 days | Participants |
| 0 |
| 47 |
| 0 |
| 47 |
| 30 |
| 47 |
| EG001 | Treatment Group (Double-blind Phase) | Nabilone 0.25 mg Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis | 0 | 19 | 0 | 19 | 4 | 19 |
| EG002 | Placebo Group (Double-blind Phase) | Placebo (corn starch) Placebo: capsule, corn starch, daily basis | 0 | 19 | 0 | 19 | 9 | 19 |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Pain (including worsening) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fall (including recurrent falls) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dry mouth | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Daytime sleepiness | Nervous system disorders | Non-systematic Assessment |
|
Not provided
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| MDS-UPDRS 1.7 Nighttime sleep problems |
|
| Total number of patients with Adverse Events |
|
| Baseline: Change supine - 3 min standing, DBP |
|
| week4: Change supine - 3 min standing, DBP |
|