Parkinson DiseasePhase 2NMS-NabNCT03769896
Nabilone for Non-motor Symptoms in Parkinson's Disease
A Phase 2 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 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. 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?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 3 Oct 2017to 15 Jul 2019
- Phase
- Phase 2
- 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 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
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- 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
- Women of childbearing potential must use or attest an acceptable method* of contraception starting 4 weeks prior to study drug administration and for a minimum of 1 month after study completion.
- Men with a potentially fertile partner must be willing to use an acceptable method of contraception for the duration of the study and for 3 months after study drug discontinuation or have had a vasectomy.
Who cannot join
- Patients with any of the following characteristics will be excluded from entering the study:
- Patient previously participated in any study with nabilone.
- Current use of cannabinoids or use of cannabinoids within 30 days prior to screening.
- Patient is currently participating in or has participated in another study of investigational products within 30 days prior to screening.
- Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post stroke).
- Patient presents with motor complications which are, based on the investigator's judgment, not adequately controlled (i.e. a score ≥2 on one of the items of the MDS-UPDRS Part IV at screening)
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- Hoehn and Yahr stage > 3
- Evidence of disturbing (i.e. requiring treatment) impulse control disorder in the participant. Can be resolved through a structural interview during screening period.
- History of neurosurgical intervention for PD
- presence of symptomatic orthostatic hypotension at screening (MDS-UPDRS 1.12 > 2)
- Use of prohibited medication (e.g. benzodiazepines (except for clonazepam up to a maximum of 1.5 mg per d), lithium, opioids, buspirone, muscle relaxing agents, central nervous system depressing substances, ...)
- Patients with laboratory values that are out-of-range at Screening (or within 4 weeks prior to Screening) and haven´t been reviewed and documented as not clinically significant by the investigator. Lab Tests can be repeated for confirmation.
- Patients with known or newly diagnosed sinus tachycardia in ECG evaluation at Screening or within 4 weeks prior to Screening.
- presence of an acute or chronic major psychiatric disorder (e.g., Major Depressive Disorder, psychosis) or symptom (e.g., hallucinations, agitation, paranoia) (MDS-UPDRS 1.2 and/or 1.3 > 2)
- Patients who had a recent suicidal attempt (active, interrupted, aborted) within the past five years or report suicidal ideation within the past 6 months.
- presence of dementia (MDS-UPDRS 1.1 > 2, Mini-Mental State Examination of <24 at the Screening visit)
- clinically significant or unstable medical or surgical condition at Screening or Baseline visit that may preclude safety and the completion of the study participation (based on the investigator's judgment).
- Patients with moderate or severe hepatic or renal impairment.
- Patient has a history of chronic alcohol or drug abuse within the last 2 years.
- women of child-bearing potential who do not practice an acceptable method of birth control
- Pregnant women or women planning to become pregnant during the course of the study and nursing women.
- Patients who are knowingly hypersensitive to any of the components of the investigational medicinal product or excipients.
- Patient is legally incapacitated or persons held in an institution by legal or official order
- Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator
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: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal 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 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.
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Being tested
- Nabilone 0.25 mg, Placebo
- 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
capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
PlaceboDrug
capsule, corn starch, daily basis
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Nabilone 0.25 mg Receives: Drug: Nabilone 0.25 mg |
| Placebo Group | Placebo comparator | Placebo (corn starch) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 4 weeks + 2 days
Secondary outcomes (21)
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.
Measured: from baseline to 4 weeks + 2 days
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: from baseline to week 4 + 2 days
Subject Incompliance in PD Patients Taking Nabilone
subject incompliance as per drug accountability.
Measured: from baseline to week 4 + 2 days
Weight (kg) in PD Patients Taking Nabilone.
changes in weight (kg)
Measured: from baseline to week 4 + 2 days
Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.
changes in temperature (degree Celsius)
Measured: 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:
- Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the baseline visit
- Mean Change of systolic blood pressure readings (SBP) from supine to standing position for 3 min at the week 4 - visit
- Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the baseline visit
- Mean Change of diastolic blood pressure readings (DBP) from supine to standing position for 3 min at the week 4 - visit
Measured: 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)
Measured: from baseline to week 4 + 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start3 Oct 2017
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT03769896
- Sponsor's protocol ID
- 1.4
- Acronym
- NMS-Nab
- Status last verified
- Feb 2021
- First submitted
- 6 Dec 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.
Publications
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.
PubMed 35937495Peball 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.
PubMed 32757413
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: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal Study
- ClinicalTrials.gov ID
- NCT03769896
- Acronym / sponsor ID
- NMS-Nab / 1.4
- Conditions
- Parkinson Disease
- Keywords
- Parkinson´s Disease, cannabinoids, non-motor symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 10 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: Nabilone 0.25 mgNabilone 0.25 mg |
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo (corn starch) |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (24 listed)
- Patients with any of the following characteristics will be excluded from entering the study:
- Patient previously participated in any study with nabilone.
- Current use of cannabinoids or use of cannabinoids within 30 days prior to screening.
- Patient is currently participating in or has participated in another study of investigational products within 30 days prior to screening.
- Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post stroke).
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 mgcapsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis | Drug | Treatment Group |
| Placebocapsule, corn starch, daily basis | Drug | Placebo Group |
Primary outcome
Changes of Non-motor Symptoms
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.
21 secondary outcomes
Changes in Motor and Different Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Changes in Different Domains of Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Changes in Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Changes in Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Changes in Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Changes in Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Changes in Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Changes in Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Changes in Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Changes in Non-motor Symptoms of PD
Time frame: from baseline to 4 weeks + 2 days
Clinical Global Impression - Global Improvement (CGI-I) Scale
Time frame: Values of the Termination visit (4 weeks + 2 days from baseline)
Incidence of AEs and Number of Withdrawals in PD Patients Taking Nabilone.
Time frame: from baseline to 4 weeks + 2 days
Suicidality in PD Patients Taking Nabilone.
Time frame: from baseline to 4 weeks + 2 days
Change in Hallucinations in PD Patients Taking Nabilone
Time frame: from baseline to 4 weeks + 2 days
Orthostatic Hypotension in PD Patients Taking Nabilone
Time frame: from baseline to week 4 + 2 days
Day-time Sleepiness in PD Patients Taking Nabilone: MDS-UPDRS
Time frame: from baseline to week 4 + 2 days
Subject Incompliance in PD Patients Taking Nabilone
Time frame: from baseline to week 4 + 2 days
Weight (kg) in PD Patients Taking Nabilone.
Time frame: from baseline to week 4 + 2 days
Changes in Temperature (Degree Celsius) in PD Patients Taking Nabilone.
Time frame: from baseline to week 4 + 2 days
Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone.
Time frame: values from baseline and week 4 + 2 days
Changes in Quality of Life of PD
Time frame: from baseline to week 4 + 2 days
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.
- Derived from this study: PubMed 35937495Peball 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.
- Derived from this study: PubMed 32757413Peball 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.
- 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 2 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 10 inclusion and 24 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes of Non-motor Symptoms (time frame: from baseline to 4 weeks + 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03769896, which also lists 2 linked publications.
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.