EUCTR2020-001175-32-PL
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 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
- •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\.
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
Outcomes
Primary Outcomes
Not specified
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