Status:
COMPLETED
Nabilone for Non-motor Symptoms in Parkinson's Disease
Lead Sponsor:
Medical University Innsbruck
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-100 years
Phase:
PHASE2
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
October 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03769896
Start Date
October 3 2017
End Date
July 15 2019
Last Update
March 2 2021
Active Locations (1)
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1
Department of Neurology - Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020