EUCTR2020-001175-32-CZ
Active, not recruiting
Phase 1
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)
ConditionsParkinson's disease patients with wearing-off motor fluctuations and associated pain.MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsOngentys®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Parkinson's disease patients with wearing-off motor fluctuations and associated pain.
- Sponsor
- Bial - Portela & Ca, S.A.
- Enrollment
- 176
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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.
Outcomes
Primary Outcomes
Not specified
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