Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN)

Bial - Portela & Ca, S.A.0 sites176 target enrollmentSeptember 30, 2020

DrugsOngentys

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Bial - Portela & Ca, S.A.
Enrollment: 176
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 30, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Bial - Portela & Ca, S.A.

Eligibility Criteria

Inclusion Criteria

•At Visit 1 (Screening), patients must meet ALL of the following criteria:
•1\.Able to comprehend and willing to sign an informed consent form (ICF) and to comply with all aspects of the study.
•2\.Male or female patients aged 30 years or older.
•3\.Experiencing PD associated pain for at least 4 weeks prior to V1\.
•4\.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\).
•5\.Disease severity Stages I\-III (modified Hoehn \& Yahr staging) at ON.
•6\.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\.
•7\.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 V6\.
•8\.No changes in chronic treatment regimen for pain within the last 4 weeks before V1\. This includes medication (including but not limited to paracetamol, opioids, nonsteroidal anti\-inflammatory drugs \[NSAIDS], antidepressants anticonvulsants and corticosteroids) and non\-medication therapies (including but not limited to transcutaneous electrical nerve stimulation and bioelectrical therapy).
•9\.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).

Exclusion Criteria

•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 pain (e.g. due to malignant disease).
•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\.
•5\.Previous or planned (during the entire study duration) L\-dopa/carbidopa intestinal gel infusion, deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
•6\.Treatment with apomorphine within the last 4 weeks before V1 or likely to be needed at any time until V6\.
•7\.Previous or current use of opicapone.
•8\.Use of any other 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.