Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-motor symptoms (e.g.sleeping disorders,cognitive dysfunction, hallucinations, autonomic dysfunction including urinary incontinence, constipation,...)

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2017-000192-86-AT
• Date of registration: 10/08/2017
• Prospective Registration: Yes
• Primary sponsor: Medizinische Universität Innsbruck, Universitätsklinik für Neurologie
• Public title: Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-motor symptoms (e.g.sleeping disorders,cognitive dysfunction, hallucinations, autonomic dysfunction including urinary incontinence, constipation,...)
• Scientific title: Nabilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study
• Date of first enrolment: 15/09/2017
• Target sample size: 48
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000192-86
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: enriched enrolment randomized withdrawal study; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria

Contacts

• Name: Clinical Trial Center Neurology
• Affiliation: Medizinische Universität Innsbruck, Universitätsklinik für Neurologie

• Name: Clinical Trial Center Neurology
• Affiliation: Medizinische Universität Innsbruck, Universitätsklinik für Neurologie

Key inclusion & exclusion criteria

Inclusion criteria:
1.Age =30 years
2.Diagnosis of PD: PD should be either de novo or on stable medication without disturbing motor fluctuations or dyskinesia.
3.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)
4.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
5.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
6.Patient is informed and had enough time and opportunity to think about his/her participation in the study and has signed a current IRB-approved informed consent form
7.Contraception
a.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.
b.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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion criteria:
1.Patient previously participated in any study with nabilone.
2.Current use of cannabinoids or use of cannabinoids within 30 days prior to screening.
3.Patient is currently participating in or has participated in another study of investigational products within 30 days prior to screening.
4.Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post stroke).
5.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)
6.Hoehn and Yahr stage > 3
7.Evidence of disturbing (i.e. requiring treatment) impulse control disorder in the participant. Can be resolved through a structural interview during screening period.
8.History of neurosurgical intervention for PD
9.presence of symptomatic orthostatic hypotension at screening (MDS-UPDRS 1.12 > 2)
10.Use of prohibited medication listed in 7.4.2
11.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.
12.Patients with known or newly diagnosed sinus tachycardia in ECG Evaluation at screening or within 4 weeks prior to screening.
13.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)
14.Patients who had a recent suicidal attempt (active, interrupted, aborted) within the past five years or report suicidal ideation within the past 6 months.
15.presence of dementia (MDS-UPDRS 1.1 > 2, MMSE of <24 at the Screening visit)
16.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).
17.Patients with moderate or severe hepatic or renal impairment.
18.Patient has a history of chronic alcohol or drug abuse within the last 2 years.
19.women of child-bearing potential who do not practice an acceptable method of birth control (See: acceptable methods of birth control at 4.1.)
20.Pregnant women or women planning to become pregnant during the course of the study and nursing women.
21.Patients who are knowingly hypersensitive to any of the components of the IMP or excipients.
22.Patient is legally incapacitated (for example: patient ist incapable of giving consent personally) or persons held in an institution by legal or official order
23.Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Subjects with non-motor symptoms of Parkinson´s disease
MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Nabilone
Pharmaceutical Form: Capsule
INN or Proposed INN: NABILONE
CAS Number: 51022-71-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: The primary efficacy criterion will be measured as the change of the MDS-UPDRS Part I between baseline and week 4.

Secondary Objective: to evaluate the effect of nabilone on motor symptoms of PD and on different domains of NMS by means of the change from baseline to Week 4 in the following assessments:

MDS – Unified Parkinson´s Disease Rating Scale
Non Motor Symptoms Scale
mood/anxiety domain of MDS-UPDRS Part I (items 1.3 and 1.4)
different other domains of NMSS & MDS-UPDRS part I
Hospital anxiety and depression scale
Parkinson´s Disease Questionnaire – 39
Montreal Cognitive Assessment
Epworth Sleepiness Scale
Fatigue Severity Scale
Visual Analog Scale of Pain
King's Parkinson's disease pain scale
Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease–Rating Scale

Clinical Global Impression – Global Improvement scale at Termination Visit


Safety and Tolerability objectives on the Overall course of the study

Exploratory Objective: Eye-tracking evaluation in PD patients taking nabilone or placebo at the Screening and the Termination visit

Primary end point(s): Change from baseline to Week 4/Termination Visit in the MDS-UPDRS Part I (non-motor Expriences of daily living; nmEDL)

Main Objective: The primary efficacy objective of this study is to demonstrate the efficacy of nabilone concerning non-motor symptoms of patients with Parkinson´s disease, based on the change from baseline to Week 4/Termination visit in the MDS-UPDRS Part I.

Secondary Outcome(s)

Secondary end point(s): Secondary Efficacy Endpoints:
The change in the other assessments listed above between baseline and week 4 will be the key secondary efficacy criteria, as well as the CGI-I at Termination Visit.

Safety Endpoints:
The safety and tolerability of nabilone will be evaluated in this study using the measures described in 2.1.3. between Baseline and Week 4.


Exploratory Endpoint:
The change of the reaction time, attention span, and concentrativeness between Screening and Termination Visit as measured by the Eye-tracking examination will be an exploratory endpoint.

Timepoint(s) of evaluation of this end point: The key secondary efficacy criteria will be measured as the change in the other assessments between baseline and week 4.
The Eye-tracking Evaluation will be measured as the change between Screening and the Termination Visit.

Secondary ID(s)

NMSNabStudy

Source(s) of Monetary Support

AOP Orphan Pharmaceuticals AG

Ethics review

Status: Approved
Approval date:
Contact: