Phase 3
Completed N=22
Nabilone for Non-motor Symptoms in Parkinson's Disease
Source: ClinicalTrials.gov NCT03773796 ↗Enrolled (actual)
22
Serious AEs
18.2%
Results posted
Mar 2021
Primary outcomePrimary: AEs in PD Patients Taking Nabilone, Between V 1 and V 3 — 39 adverse events
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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). 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AEs in PD Patients Taking Nabilone, Between V 1 and V 3 |
39 | — |
| PRIMARY Number of Subjects (%) Who Discontinue the Study Due to an AE Between V 1 and V 3 |
1 | — |
| PRIMARY Number of Subjects (%) Who Discontinue the Study Due to Other Reasons Than an AE Between V 1 and V 3 |
1 | — |
| PRIMARY Suicidality in PD Patients Taking Nabilone Between V 1 and V 3 Using the Columbia-Suicide Severity Rating Scale |
— | — |
| PRIMARY Hallucinations in PD Patients Taking Nabilone Between V 1 and V 3 |
1; 0; 18 | — |
| PRIMARY Day-time Sleepiness in PD Patients Taking Nabilone Between V 1 and V 3 |
-0.05 | — |
| PRIMARY Orthostatic Hypotension in PD Patients Taking Nabilone Between V 1 and V 3 |
-0.16 | — |
| PRIMARY Subject Compliance in PD Patients Taking Nabilone. |
— | — |
| PRIMARY Changes in Supine and Standing Blood Pressure Measurements (mmHg) in PD Patients Taking Nabilone Between V 1 and V 3 |
5.14; 6.05; 0.76; -0.42 | — |
| SECONDARY Changes in Motor and Non-motor Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3 |
1.58; -0.58; -1.89; -0.16; -1.05 | — |
| SECONDARY Changes in Non-motor Symptoms (NMSS) in Patients With PD Taking Nabilone Between V 1 and V 3 |
-4.84 | — |
| SECONDARY Changes in Non-motor Symptoms (HADS) in Patients With PD Taking Nabilone Between V 1 and V 3 |
-0.16; 1.00 | — |
| SECONDARY Changes in Quality of Life in Patients With PD Taking Nabilone Between V 1 and V 3 |
-2.96 | — |
| SECONDARY Changes in Sleepiness in Patients With PD Taking Nabilone Between V 1 and V 3 |
0.11 | — |
| SECONDARY Changes in Fatigue in Patients With PD Taking Nabilone Between V 1 and V 3 |
4.26 | — |
| SECONDARY Changes in Pain in Patients With PD Taking Nabilone Between V 1 and V 3 |
-6.84 | — |
| SECONDARY Changes in Impulsive-compulsive Behaviour in Patients With PD Taking Nabilone Between V 1 and V 3 |
0.11 | — |
| SECONDARY Changes in Overall Symptoms in Patients With PD Taking Nabilone Between V 1 and V 3 |
-1.16 | — |
| SECONDARY Changes in Cognitive Function (MoCA) in Patients With PD Taking Nabilone Between V 1 and V 3 |
-0.11 | — |
| SECONDARY Changes in Cognitive Function (MMSE) in Patients With PD Taking Nabilone |
0.42 | — |
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03773796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.