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

NCT04821687 | Completed Phase 4

• 1 other identifier: OGT001
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

COMT inhibitor

Outcome Measures

Primary Outcomes (1)

• Hauser's diary

  Change in absolute OFF-time and ON-time. Since this study is exploratory, there is no separate primary endpoint.

  Baseline, at 2 weeks, and 4 weeks

Study Arms (2)

Opicapone 50mg

EXPERIMENTAL

Drug: Ongentys 50mg

Levodopa 100mg

ACTIVE COMPARATOR

Drug: Madopar Tab. 125 or Perkin Tab. 25-100mg

Interventions

Ongentys 50mg DRUG

Opicapone 50mg will be added to current and stable therapy of L-DOPA/DDCI

Opicapone 50mg

Madopar Tab. 125 or Perkin Tab. 25-100mg DRUG

Madopar Tab. 125 or Perkin Tab. 25-100mg will be added to current and stable therapy of L-DOPA/DDCI

Levodopa 100mg

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: June 17, 2021
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: June 1, 2023

Record last verified: 2021-03

Locations

KR (1)