Parkinson DiseasePhase 3NMS-Nab2NCT03773796
Nabilone for Non-motor Symptoms in Parkinson's Disease
A Phase 3 study testing Nabilone 0.25 mg in people with Parkinson Disease, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
This is an open-label extension study for participants of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study, assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients with Parkinson´s Disease (PD). Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Nabilone 0.25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- 6 Aug 2018to 31 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible for participation in the study, subjects must meet all inclusion criteria:
- In order to be eligible for the study, patients must have completed the double-blind phase of the NMS-Nab trial as responders within the last 2 months.
- For patients that completed NMS-Nab Study over 2 months prior to the Screening / Baseline Visit, and meet all other inclusion criteria, eligibility should be discussed on a case-by-case basis.
- Only patients without a drug-related serious adverse event (SAE) or (drug-related) moderate or severe AE during the NMS-Nab Study can be included in the study
- Patients must be able and willing to provide written informed consent prior to any study related procedure being performed. Patients with a legal guardian should be consented according to local requirements.
- Patients must be willing and able to take oral medication and able to comply with the study specific procedures.
- The patient is in good health as determined by medical examination and based on the investigator's judgement
Who cannot join
- Patients with any of the following characteristics will be excluded from entering the study:
- Patients with PArkinson´s Disease (PD) who have not participated in the randomized double-blind phase of the previous NMS-Nab Study.
- Patients that experienced a drug-related SAE or had a (drug-related) moderate or severe AE during the NMS-Nab Study will be excluded in the study.
- Patients who are unable or unwilling to comply with the study procedures in the investigator´s opinion.
- Patients with any clinically significant or unstable medical or surgical condition at the Screening / Baseline Visit that may preclude safety and the completion of the study participation (based on the investigator's judgement).
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Neurology - Medical University Innsbruck
Innsbruck, Tyrol, 6020
About this study
Official title: Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy
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.
Read the detailed description
This is an open-label extension study for participants of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study, assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of tetrahydrocannabinol (THC), the psychoactive component of cannabis.
Eligible subjects will be re-tapered with open-label nabilone, optimally up to the dose the patient had in the NMS-Nab Trial. It is the investigator´s decision to modify this dose, if necessary. The re-tapering will be performed up to a maximum dose of 1 mg twice daily. Treatment responders will enter the open-label treatment period for 6 months with visits being performed every 3 months in the context of the patient´s regularly scheduled visits in the specialized outpatient department. The last visit will be the Termination Visit. Following this, nabilone will be tapered. During this period the patients will receive phone calls every other day. A Safety Follow-Up Visit will be performed.
- Conditions
- Parkinson Disease
- Being tested
- Nabilone 0.25 mg
- Keywords
- Parkinson´s Disease, cannabinoids, non-motor symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nabilone 0.25 mgDrug
Also called Canemes
capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Other | Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg Receives: Drug: Nabilone 0.25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: between V 1 and V 3 (6 months)
Subject Compliance in PD Patients Taking Nabilone.
subject incompliance as per drug accountability (%)
Measured: 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:
- Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at V 1
- Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at V 3
- Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at V 1
- Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at V 3
Measured: between V 1 and V 3 (6 months)
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start6 Aug 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Seppi, MD, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773796
- Sponsor's protocol ID
- 1.3
- Acronym
- NMS-Nab2
- Status last verified
- Feb 2021
- First submitted
- 19 Jul 2018
- Last updated
- 2 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy
- ClinicalTrials.gov ID
- NCT03773796
- Acronym / sponsor ID
- NMS-Nab2 / 1.3
- Conditions
- Parkinson Disease
- Keywords
- Parkinson´s Disease, cannabinoids, non-motor symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Posted 2 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label extension study for participants of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study, assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients with Parkinson´s Disease (PD). Nabilone is an analogue of tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and therefore mimics the effect of THC but with more predictable side effects and less euphoria.
Eligible patients will be re-tapered in an open-label nabilone dose optimization phase followed by an open-label period of 6 months on a stable nabilone dose.
Detailed description
This is an open-label extension study for participants of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study, assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of tetrahydrocannabinol (THC), the psychoactive component of cannabis.
Eligible subjects will be re-tapered with open-label nabilone, optimally up to the dose the patient had in the NMS-Nab Trial. It is the investigator´s decision to modify this dose, if necessary. The re-tapering will be performed up to a maximum dose of 1 mg twice daily. Treatment responders will enter the open-label treatment period for 6 months with visits being performed every 3 months in the context of the patient´s regularly scheduled visits in the specialized outpatient department. The last visit will be the Termination Visit. Following this, nabilone will be tapered. During this period the patients will receive phone calls every other day. A Safety Follow-Up Visit will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Other | Drug: Nabilone 0.25 mgAssessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to be eligible for participation in the study, subjects must meet all inclusion criteria:
- In order to be eligible for the study, patients must have completed the double-blind phase of the NMS-Nab trial as responders within the last 2 months.
- For patients that completed NMS-Nab Study over 2 months prior to the Screening / Baseline Visit, and meet all other inclusion criteria, eligibility should be discussed on a case-by-case basis.
- Only patients without a drug-related serious adverse event (SAE) or (drug-related) moderate or severe AE during the NMS-Nab Study can be included in the study
- Patients must be able and willing to provide written informed consent prior to any study related procedure being performed. Patients with a legal guardian should be consented according to local requirements.
Key exclusion criteria (5 listed)
- Patients with any of the following characteristics will be excluded from entering the study:
- Patients with PArkinson´s Disease (PD) who have not participated in the randomized double-blind phase of the previous NMS-Nab Study.
- Patients that experienced a drug-related SAE or had a (drug-related) moderate or severe AE during the NMS-Nab Study will be excluded in the study.
- Patients who are unable or unwilling to comply with the study procedures in the investigator´s opinion.
- Patients with any clinically significant or unstable medical or surgical condition at the Screening / Baseline Visit that may preclude safety and the completion of the study participation (based on the investigator's judgement).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nabilone 0.25 mgAlso: Canemescapsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis | Drug | Treatment Group |
Primary outcome
AEs in PD Patients Taking Nabilone, Between V 1 and V 3
Time frame: 6 months
Safety and tolerability will be evaluated with reference to the following: Adverse Events (AE)
Number of Subjects (%) Who Discontinue the Study Due to an AE Between V 1 and V 3
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.
Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3
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.
Suicidality in PD Patients Taking Nabilone Between V 1 and V 3 Using the Columbia-Suicide Severity Rating Scale
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.
Hallucinations in PD Patients Taking Nabilone Between V 1 and V 3
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.
Day-time Sleepiness in PD Patients Taking Nabilone Between V 1 and V 3
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.
Orthostatic Hypotension in PD Patients Taking Nabilone Between V 1 and V 3
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.
Subject Compliance in PD Patients Taking Nabilone.
Time frame: between V 1 and V 3 (6 months)
subject incompliance as per drug accountability (%)
Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3
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
11 secondary outcomes
Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: between V 1 and V 3 (6 months)
Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3
Time frame: between V 1 and V 3 (6 months)
Changes in Fatigue in Patients With PD Taking Nabilone Between V 1 and V 3
Time frame: between V 1 and V 3 (6 months)
Changes in Pain in Patients With PD Taking Nabilone Between V 1 and V 3
Time frame: 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
Time frame: between V 1 and V 3 (6 months)
Changes in Overall Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3
Time frame: 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
Time frame: 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
Time frame: from screening of the preceding study (NCT03769896) to V 3 of this study (a maximum of 2 years, at study completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nabilone 0.25 mg in people with Parkinson Disease, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs in PD Patients Taking Nabilone, Between V 1 and V 3 (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.