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 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.
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 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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
CanemesSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Safety and tolerability will be evaluated with reference to the following: Adverse Events (AE)
Population: primary endpoint was safety, please refer to Adverse events section.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 21 | 39 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 21 | 1 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 21 | 1 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 21 | 0 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group · less hallucinations | 19 | 1 | - |
| Treatment Group · more hallucinations | 19 | 0 | - |
| Treatment Group · no change | 19 | 18 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -0.05 | 0.83 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -0.16 | 0.77 |
subject incompliance as per drug accountability (%)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0 | - |
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
Population: 21 patients for V 1 and 19 for V 3 analyzed.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 21 | 5.14 | 7.15 |
| Treatment Group | 21 | 6.05 | 11.40 |
| Treatment Group | 21 | 0.76 | 6.96 |
| Treatment Group | 21 | -0.42 | 9.05 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 1.58 | 13.87 |
| Treatment Group | 19 | -0.58 | 3.49 |
| Treatment Group | 19 | -1.89 | 6.88 |
| Treatment Group | 19 | -0.16 | 2.14 |
| Treatment Group | 19 | -1.05 | 15.90 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -4.84 | 18.08 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -0.16 | 1.30 |
| Treatment Group | 19 | 1.00 | 2.08 |
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).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -2.96 | 9.11 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.11 | 2.75 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 4.26 | 10.08 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -6.84 | 15.12 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.11 | 1.41 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -1.16 | 1.30 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | -0.11 | 1.94 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Treatment Group | 19 | 0.42 | 1.84 |
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.
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.
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.
| Milestone | Treatment Group |
|---|---|
| STARTED | 22 |
| COMPLETED | 19 |
| NOT COMPLETED | 3 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| rectum carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Treatment Group: 1 / 22 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Treatment Group: 1 / 22 |
| Worsening of Parkinson´s disease symptoms | Nervous system disorders | Treatment Group: 1 / 22 |
| Vomiting | Gastrointestinal disorders | Treatment Group: 1 / 22 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| respiratory tract infection | Infections and infestations | Treatment Group: 3 / 22 |
| Concentration difficulties | Nervous system disorders | Treatment Group: 2 / 22 |
| intermittant falls | Nervous system disorders | Treatment Group: 3 / 22 |
| Urinary tract infection | Renal and urinary disorders | Treatment Group: 1 / 22 |
| transient numbness of the face | Nervous system disorders | Treatment Group: 2 / 22 |
| Osteopenia | Metabolism and nutrition disorders | Treatment Group: 2 / 22 |
| Insomnia | Nervous system disorders | Treatment Group: 2 / 22 |
| Back pain | Musculoskeletal and connective tissue disorders | Treatment Group: 1 / 22 |
| Worsening of Parkinson´s Disease symptoms | Nervous system disorders | Treatment Group: 2 / 22 |
| Osteoarthropathy | Musculoskeletal and connective tissue disorders | Treatment Group: 1 / 22 |
Eligibility
primary outcomes
Time frame: 6 months
Safety and tolerability will be evaluated with reference to the following: Adverse Events (AE)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: between V 1 and V 3 (6 months)
subject incompliance as per drug accountability (%)
Time frame: 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
secondary outcomes
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
other outcomes
Time frame: 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.
Time frame: 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.
Time frame: 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.
Publications
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