Nabilone 0.25 mg
capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2021-03-02
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
capsule, corn starch, daily basis
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 1.00 | -0.16 to 2.16 |
| Placebo Group | 19 | 2.63 | 1.53 to 3.74 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.47 | -0.37 to 1.31 |
| Placebo Group | 19 | 0.90 | -0.35 to 2.14 |
| Treatment Group | 19 | 0.53 | -2.24 to 3.29 |
| Placebo Group | 19 | 2.63 | 0.25 to 5.02 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.11 | -0.17 to 0.38 |
| Placebo Group | 19 | 0.16 | -0.08 to 0.40 |
| Treatment Group | 19 | -0.16 | -0.53 to 0.21 |
| Placebo Group | 19 | 0.21 | -0.05 to 0.47 |
| Treatment Group | 19 | 0.05 | -0.47 to 0.57 |
| Placebo Group | 19 | 1.79 | 1.15 to 2.42 |
Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 4.05 | -0.65 to 8.75 |
| Placebo Group | 19 | 11.00 | 4.68 to 17.32 |
Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.26 | -0.87 to 1.40 |
| Placebo Group | 19 | 0.05 | -1.09 to 1.19 |
| Treatment Group | 19 | 0.32 | -1.11 to 1.74 |
| Placebo Group | 19 | 0.16 | -0.71 to 1.03 |
Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -0.74 | -1.87 to 0.40 |
| Placebo Group | 19 | -0.79 | -1.85 to 0.27 |
Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -4.00 | -9.77 to 1.77 |
| Placebo Group | 19 | 0.00 | -5.26 to 5.26 |
King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 1.58 | -2.73 to 5.89 |
| Placebo Group | 19 | 2.84 | -5.19 to 10.87 |
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -0.68 | -1.49 to 0.12 |
| Placebo Group | 19 | 0.05 | -0.64 to 0.74 |
Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.74 | -0.18 to 1.66 |
| Placebo Group | 19 | 0.00 | -0.63 to 0.62 |
Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 6.58 | -5.65 to 18.81 |
| Placebo Group | 19 | 2.16 | -8.40 to 12.71 |
Clinical Global Impression - Global Improvement (CGI-I) scale Minimum: 1, maximum: 7, higher score values indicate a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 4.95 | 0.71 |
| Placebo Group | 19 | 4.42 | 0.61 |
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)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0 | - |
| Placebo Group | 19 | 0 | - |
| Treatment Group | 19 | 0 | - |
| Placebo Group | 19 | 0 | - |
| Treatment Group | 19 | 6 | - |
| Placebo Group | 19 | 8 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0 | - |
| Placebo Group | 19 | 0 | - |
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).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0 | - |
| Placebo Group | 19 | 0 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.21 | -0.13 to 0.55 |
| Placebo Group | 19 | -0.26 | -0.65 to 0.13 |
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
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.26 | -0.01 to 0.53 |
| Placebo Group | 19 | 0.11 | -0.21 to 0.42 |
subject incompliance as per drug accountability.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0 | - |
| Placebo Group | 19 | 0 | - |
changes in weight (kg)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -0.70 | 2.33 |
| Placebo Group | 19 | -0.52 | 2.37 |
changes in temperature (degree Celsius)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.17 | 0.56 |
| Placebo Group | 19 | 0.35 | 0.48 |
changes in supine and standing blood pressure measurements (mmHg) Row titles: 1. Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the baseline visit 2. Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the week 4 - visit 3. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the baseline visit 4. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the week 4 - visit
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 1.47 | 13.88 |
| Placebo Group | 19 | -4.05 | 11.53 |
| Treatment Group | 19 | -1.84 | 10.68 |
| Placebo Group | 19 | -2.95 | 17.96 |
| Treatment Group | 19 | 3.79 | 5.84 |
| Placebo Group | 19 | 3.16 | 6.07 |
| Treatment Group | 19 | 4.11 | 5.95 |
| Placebo Group | 19 | -0.79 | 7.90 |
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)
Population: PDQ-39 SI values reported
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -0.49 | -3.04 to 2.05 |
| Placebo Group | 19 | -0.47 | -3.21 to 2.28 |
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.
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.
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.
| Milestone | Treatment Group | Placebo Group |
|---|---|---|
| STARTED | 47 | 0 |
| COMPLETED | 38 | 0 |
| NOT COMPLETED | 9 | 0 |
| Milestone | Treatment Group | Placebo Group |
|---|---|---|
| STARTED | 19 | 19 |
| COMPLETED | 19 | 19 |
| NOT COMPLETED | 0 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Insomnia | Nervous system disorders | Treatment Group (Open-label Phase): 0 / 47 · Treatment Group (Double-blind Phase): 2 / 19 · Placebo Group (Double-blind Phase): 2 / 19 |
| Upper respiratory tract infection | Infections and infestations | Treatment Group (Open-label Phase): 4 / 47 · Treatment Group (Double-blind Phase): 0 / 19 · Placebo Group (Double-blind Phase): 3 / 19 |
| Pain (including worsening) | Musculoskeletal and connective tissue disorders | Treatment Group (Open-label Phase): 4 / 47 · Treatment Group (Double-blind Phase): 1 / 19 · Placebo Group (Double-blind Phase): 2 / 19 |
| Fall (including recurrent falls) | Musculoskeletal and connective tissue disorders | Treatment Group (Open-label Phase): 2 / 47 · Treatment Group (Double-blind Phase): 1 / 19 · Placebo Group (Double-blind Phase): 1 / 19 |
| Syncope | Nervous system disorders | Treatment Group (Open-label Phase): 0 / 47 · Treatment Group (Double-blind Phase): 0 / 19 · Placebo Group (Double-blind Phase): 1 / 19 |
| Fatigue | Nervous system disorders | Treatment Group (Open-label Phase): 13 / 47 · Treatment Group (Double-blind Phase): 0 / 19 · Placebo Group (Double-blind Phase): 0 / 19 |
| Dizziness | Nervous system disorders | Treatment Group (Open-label Phase): 9 / 47 · Treatment Group (Double-blind Phase): 0 / 19 · Placebo Group (Double-blind Phase): 0 / 19 |
| Dry mouth | Skin and subcutaneous tissue disorders | Treatment Group (Open-label Phase): 4 / 47 · Treatment Group (Double-blind Phase): 0 / 19 · Placebo Group (Double-blind Phase): 0 / 19 |
| Daytime sleepiness | Nervous system disorders | Treatment Group (Open-label Phase): 4 / 47 · Treatment Group (Double-blind Phase): 0 / 19 · Placebo Group (Double-blind Phase): 0 / 19 |
Eligibility
primary outcomes
Time frame: from baseline to 4 weeks + 2 days
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.
secondary outcomes
Time frame: from baseline to 4 weeks + 2 days
Changes in Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Part II: minimum points: 0, maximum points: 52, higher score values indicate a worse outcome. Part III: minimum points: 0, maximum points: 132, higher score values indicate a worse outcome.
Time frame: from baseline to 4 weeks + 2 days
mood/anxiety domain of MDS-UPDRS Part I (items 1.3 and 1.4) and different other domains of NMSS and MDS-UPDRS part I Each items scores 0 to 4 points with higher score values indicating a worse outcome.
Time frame: from baseline to 4 weeks + 2 days
Non Motor Symptoms Scale (NMSS) Minimum: 0, maximum: 360, higher score values indicate a worse outcome.
Time frame: from baseline to 4 weeks + 2 days
Hospital anxiety and depression scale (HAD-S) Minimum: 0, maximum: 42, higher score values indicate a worse outcome.
Time frame: from baseline to 4 weeks + 2 days
Epworth Sleepiness Scale (ESS) Minimum: 0, maximum: 24, higher score values indicate a worse outcome.
Time frame: from baseline to 4 weeks + 2 days
Fatigue Severity Scale (FSS) Minimum: 9, maximum: 63, higher score values indicate a worse outcome.
Time frame: from baseline to 4 weeks + 2 days
King's Parkinson's disease pain scale (KPPS) Minimum: 0, maximum: 168, higher score values indicate a worse outcome.
Time frame: from baseline to 4 weeks + 2 days
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Minimum: 0, maximum: 112, higher score values indicate a worse outcome.
Time frame: from baseline to 4 weeks + 2 days
Montreal Cognitive Assessment (MoCA) Minimum: 0, maximum: 30, higher score values indicate better outcome.
Time frame: from baseline to 4 weeks + 2 days
Visual Analog Scale (VAS) of Pain Minimum: 0 mm, maximum: 10 mm, higher score values indicate a worse outcome.
Time frame: 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.
Time frame: from baseline to 4 weeks + 2 days
Safety and tolerability will be evaluated with reference to the following: Number of subjects (%) who discontinue the study Number of subjects (%) who discontinue the study due to AE Adverse Events (AE): total number of patients with all adverse events is reported (no reporting threshold)
Time frame: from baseline to 4 weeks + 2 days
Assessment of aggregated data (suicidality present / no suicidality) of the Columbia-Suicide Severity Rating Scale (C-SSRS). The scale consists of questions for suicidality that can be answered with either "yes" or "no". The answer "no" indicates no wish to be dead, no suicidal ideations, or suicidal attempts. No minimum or maximum score values can be provided. The values provided represent the number of patients with (new) suicidality.
Time frame: from baseline to 4 weeks + 2 days
Number of patients with changes in the points of the Hallucination item (1.2) of the Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).
Time frame: from baseline to week 4 + 2 days
Changes in points of the Orthostatic hypotension (OH) item (1.12) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS), minimum of 0, maximum of 4 points, higher score values representing a worse outcome.
Time frame: from baseline to week 4 + 2 days
Changes in points of the Day-time sleepiness item (1.8) of Movement Disorders Society - Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) , minimum of 0, maximum of 4 points, higher score values representing a worse outcome
Time frame: from baseline to week 4 + 2 days
subject incompliance as per drug accountability.
Time frame: from baseline to week 4 + 2 days
changes in weight (kg)
Time frame: from baseline to week 4 + 2 days
changes in temperature (degree Celsius)
Time frame: values from baseline and week 4 + 2 days
changes in supine and standing blood pressure measurements (mmHg) Row titles: 1. Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the baseline visit 2. Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the week 4 - visit 3. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the baseline visit 4. Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the week 4 - visit
Time frame: from baseline to week 4 + 2 days
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)
other outcomes
Time frame: Maximum of 104 days
Change of the reaction time (seconds) between the Screening visit (Part 1) and the Termination visit (Part 2) as measured by the Eye-tracking examination.
Time frame: Maximum of 104 days
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.
Publications