abilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study

Medizinische Universität Innsbruck, Universitätsklinik für Neurologie0 sites48 target enrollmentAugust 10, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Medizinische Universität Innsbruck, Universitätsklinik für Neurologie
Enrollment: 48
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

August 10, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Medizinische Universität Innsbruck, Universitätsklinik für Neurologie

•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

•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