Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS)

Bial - Portela & Ca, S.A.0 sites30 target enrollmentJanuary 4, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders.
Sponsor: Bial - Portela & Ca, S.A.
Enrollment: 30
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

January 4, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Able to comprehend and willing to sign an informed consent form and to comply with all aspects of the study.
•2\. Male or female patients aged 30 years or older.
•3\. Diagnosed with idiopathic PD according to the UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria (2006\) or according to MDS Clinical Diagnostic Criteria (2015\).
•4\. Signs of wearing\-off” phenomenon (end\-of\-dose motor fluctuations) with average total daily OFF time while awake of at least 1\.5 hours, excluding the early morning pre\-first dose OFF, despite optimal anti\-PD therapy (based on investigator’s assessment).
•5\. Disease severity Stages I\-III (modified Hoehn \& Yahr staging) at ON.
•6\. Experiencing PD associated sleep disorders for at least 4 weeks prior to V1\.
•7\. Total PDSS\-2 score \= 18\.
•8\. Treated with 3 to 8 intakes per day of L\-dopa/DDCI (which may include a slow\-release formulation), on a stable regimen for at least 4 weeks before V1\.
•9\. In case of any other anti\-PD treatment, it should be on a stable regimen for at least 4 weeks before V1, and not likely to need any adjustment until V4\.
•10\. No change in the chronic treatment regimen within the last 4 weeks before V1 of the following medication: sedatives, hypnotics, anti\-depressants, anxiolytics or other medications prescribed for the treatment of sleep disorders

•1\. Non\-idiopathic PD (atypical parkinsonism, secondary \[acquired or symptomatic] parkinsonism, Parkinson\-plus syndrome).
•2\. Severe and/or unpredictable OFF periods, according to investigator judgement.
•3\. Major/prominent non\-PD\-related sleep disorders (e.g. sleep apnoea or narcolepsy).
•4\. Treatment with prohibited medication: entacapone, tolcapone, monoamine oxidase (MAO) inhibitors (except selegiline up to 10 mg/day in oral formulation or 1\.25 mg/day in buccal absorption formulation, rasagiline up to 1 mg/day or safinamide up to 100 mg/day), or antiemetics with antidopaminergic action (except domperidone) within the last 4 weeks before V1 or likely to be needed at any time until V4\.
•5\. Treatment with apomorphine within the last 4 weeks before V1 or likely to be needed at any time until V4\.
•6\. Previous or current use of opicapone.
•7\. Previous or planned (until the end of this study) L\-dopa/carbidopa intestinal gel infusion, deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
•8\. Use of any other investigational product (IP), currently or within the 3 months (or within 5 half\-lives of the IP, whichever is longer) before V1\.
•9\. Past (within the past year) or present history of suicidal ideation or suicide attempts.
•10\. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine.