Status:
COMPLETED
A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief Summary
A Study to evaluate the add-on efficacy and safety of opicapone 50 mg or an extra dose of L-DOPA 100 mg for the treatment of wearing-off in patients with PD.
Eligibility Criteria
Inclusion
- Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (2006) or according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015).
- Disease severity Stage III (H\&Y staging) at ON.
- Treated on a stable regimen for at least four weeks before screening with immediate-release L-DOPA/DDCI, three to four intakes per day, and up to maximum daily dose of 600mg L-DOPA.
- Signs of wearing-off phenomenon with average total daily OFF-time while awake of at least 1 hour, including the early morning pre-first dose OFF (i.e. the time between wake-up and response to the first L-DOPA/DDCI dosage), despite optimal anti-PD therapy (based on Investigator's assessment).
Exclusion
- Non-idiopathic PD (atypical Parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, Parkinson-plus syndrome.
- Severe and/or unpredictable OFF periods, according to Investigator judgment.
- Average total daily OFF-time while awake of \>5 hours, including the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on Investigator's assessment).
- 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), apomorphine or antiemetics with antidopaminergic action (except domperidone) within the last four weeks before screening.
- Previous or planned (during the entire study duration) deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
Key Trial Info
Start Date :
June 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT04821687
Start Date
June 17 2021
End Date
August 18 2022
Last Update
June 1 2023
Active Locations (1)
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1
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea