Parkinson DiseasePhase 4OCEANNCT04986982
OpiCapone Effect on Motor Fluctuations and pAiN
A Phase 4 study testing Opicapone 50 mg in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's disease (PD) patients with end-of-dose motor fluctuations and associated pain Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Opicapone 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Feb 2021to 16 Feb 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to comprehend and willing to sign an informed consent form and to comply with all aspects of the study.
- Male or female patients aged 30 years or older.
- Experiencing PD associated pain for at least 4 weeks prior to V1.
- 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).
- Disease severity Stages I-III (modified Hoehn \& Yahr staging) at ON.
- 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.
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- 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.
- 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).
- 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).
- Domain 3 of KPPS ≥ 12.
- For females: Postmenopausal for at least 2 years before V1, surgically sterile for at least 6 months before V1, or practicing effective contraception until V6. Female patients who request to continue with oral contraceptives must be willing to use non-hormonal methods of contraception in addition during the course of this study.
- For males: Male patients who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception during the treatment period until V6.
- Have filled-in self-rating diary in accordance with the diary instructions and with ≤ 3 missing entries per day, in the 3 days preceding V2a/V2b.
- With at least 1.5 OFF hours per day, excluding the early morning pre-first dose OFF period (i.e. the time between wake-up and response to the first L dopa/DDCI dosage), as recorded in at least 2 of the 3 days in the self-rating diary for the 3 days preceding V2a/V2b.
- Results of the screening laboratory tests are considered acceptable by the investigator (i.e. not clinically relevant for the well-being of the patient or for the purpose of the study).
- Domain 3 of KPPS ≥ 12.
- Adequate compliance to relevant (PD and pain related) concomitant medication during the screening period (based on the investigator's judgment).
Who cannot join
- Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
- Severe and/or unpredictable OFF periods, according to investigator judgement.
- Major/prominent non-PD-related pain (e.g. due to malignant disease).
- 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.
- Previous or planned (during the entire study duration) L-dopa/carbidopa intestinal gel infusion, deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
- Treatment with apomorphine within the last 4 weeks before V1 or likely to be needed at any time until V6.
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- Previous or current use of opicapone.
- Use of any other IP, currently or within the 3 months (or within 5 half-lives of the IP, whichever is longer) before V1.
- Past (within the past year) or present history of suicidal ideation or suicide attempts.
- Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine.
- Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
- Known hypersensitivity to the excipients of IP (including lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption) or of rescue medication.
- History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis.
- History of severe hepatic impairment (Child-Pugh Class C).
- Previous history of psychosis or psychiatric disorders, including severe major depression.
- Any medical condition that might place the patient at increased risk or interfere with assessments.
- For females: Pregnant or breastfeeding.
- Employees of the investigator, study centre, sponsor, clinical research organisation and study consultants, when employees are directly involved in this study or other studies under the direction of this investigator or study centre, and their family members.
- Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Maurice Wohl Clinical Neuroscience Institute - King's College Hospital
London, SE5 9RT
About this study
Official title: 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.
The aim of this study is to investigate the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's disease (PD) patients with end-of-dose motor fluctuations and associated pain
Read the detailed description
This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group, interventional clinical study in PD patients with end-of-dose motor fluctuations and associated pain. The study consists of a 1-week screening period, a 24-week double-blind treatment period and 2 weeks of follow-up period. The duration of treatment for the individual patient is expected to be up to 24 weeks.
- Conditions
- Parkinson Disease
- Being tested
- Opicapone 50 mg, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opicapone 50 mgDrug
Also called BIA 9-1067
Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
PlaceboOther
Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
| Study group | Role | What they receive |
|---|---|---|
| Opicapone 50 mg | Experimental | Opicapone (BIA 9-1067) Receives: Drug: Opicapone 50 mg |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
The KING's PARKINSON's DISEASE PAIN SCALE (KPPS) evaluates the burden (global and bedside) and characterises various phenotypes of pain in Parkinson's disease. The investigator will complete the questionnaire by interviewing the patient about seven domains and answering to 14 items. The questionnaire will be fill out on Visit 1, Visit 2b/Baseline, Visit 4, Visit 5 and Visit 6/EDV Domain 3 assesses fluctuation-related pain (score range: 0 - 36). Higher score values indicate higher levels of pain.
Measured: The questionnaire will be fill out on Visit 1 (Day -7 ±2), Visit 2b/Baseline (Day 1), Visit 4 (Day 29 (±2)), Visit 5 (Day 85 (±4)) and Visit 6/Early Discontinuation Visit (EDV) (Day 169 (±4)) - Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start25 Feb 2021
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kallol Ray Chaudhuri, MD, DSc, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986982
- Sponsor's protocol ID
- BIA-91067-404
- Other IDs
- 2020-001175-32
- Acronym
- OCEAN
- Status last verified
- Mar 2025
- First submitted
- 27 Jul 2021
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04986982
- Acronym / sponsor ID
- OCEAN / BIA-91067-404
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's disease (PD) patients with end-of-dose motor fluctuations and associated pain
Detailed description
This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group, interventional clinical study in PD patients with end-of-dose motor fluctuations and associated pain. The study consists of a 1-week screening period, a 24-week double-blind treatment period and 2 weeks of follow-up period. The duration of treatment for the individual patient is expected to be up to 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opicapone 50 mg | Experimental | Drug: Opicapone 50 mgOpicapone (BIA 9-1067) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Able to comprehend and willing to sign an informed consent form and to comply with all aspects of the study.
- Male or female patients aged 30 years or older.
- Experiencing PD associated pain for at least 4 weeks prior to V1.
- 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).
- Disease severity Stages I-III (modified Hoehn \& Yahr staging) at ON.
Key exclusion criteria (19 listed)
- Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
- Severe and/or unpredictable OFF periods, according to investigator judgement.
- Major/prominent non-PD-related pain (e.g. due to malignant disease).
- 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.
- Previous or planned (during the entire study duration) L-dopa/carbidopa intestinal gel infusion, deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opicapone 50 mgAlso: BIA 9-1067Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI | Drug | Opicapone 50 mg |
| PlaceboMatching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI | Other | Placebo |
Primary outcome
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Time frame: The questionnaire will be fill out on Visit 1 (Day -7 ±2), Visit 2b/Baseline (Day 1), Visit 4 (Day 29 (±2)), Visit 5 (Day 85 (±4)) and Visit 6/Early Discontinuation Visit (EDV) (Day 169 (±4)) - Up to 24 weeks
The KING's PARKINSON's DISEASE PAIN SCALE (KPPS) evaluates the burden (global and bedside) and characterises various phenotypes of pain in Parkinson's disease. The investigator will complete the questionnaire by interviewing the patient about seven domains and answering to 14 items. The questionnaire will be fill out on Visit 1, Visit 2b/Baseline, Visit 4, Visit 5 and Visit 6/EDV Domain 3 assesses fluctuation-related pain (score range: 0 - 36). Higher score values indicate higher levels of pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- King's Parkinson's Disease Pain ScaleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kallol Ray Chaudhuri, MD, DSc principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Opicapone 50 mg in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS) (time frame: The questionnaire will be fill out on Visit 1 (Day -7 ±2), Visit 2b/Baseline (Day 1), Visit 4 (Day 29 (±2)), Visit 5 (Day 85 (±4)) and Visit 6/Early Discontinuation Visit (EDV) (Day 169 (±4)) - Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.