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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Opicapone 50mg
|
Drug: Ongentys 50mg
Opicapone 50mg will be added to current and stable therapy of L-DOPA/DDCI
|
| Active Comparator: Levodopa 100mg
|
Drug: Madopar Tab. 125 or Perkin Tab. 25-100mg
Madopar Tab. 125 or Perkin Tab. 25-100mg will be added to current and stable therapy of L-DOPA/DDCI
|
Outcome Measures
Primary Outcome Measures
- Hauser's diary [Baseline, at 2 weeks, and 4 weeks]
Change in absolute OFF-time and ON-time. Since this study is exploratory, there is no separate primary endpoint.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | Korea, Republic of |
Sponsors and Collaborators
- SK Chemicals Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OGT001