Parkinson's Disease With Wearing-off Motor FluctuationsPhase 4OPTIPARKNCT02847442
Efficacy and Safety of Opicapone in Clinical Practice
A Phase 4 study testing BIA 9-1067 and levodopa/dopa decarboxylase inhibitor in people with Parkinson's Disease With Wearing-off Motor Fluctuations, run by Bial - Portela C S.A. at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the change in subject's condition according to the Investigator's Global Assessment of Change after three months of treatment with 50 mg opicapone once daily in a heterogeneous patient population reflecting daily clinical practice. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease With Wearing-off Motor Fluctuations
- What is being tested?
- BIA 9-1067 and levodopa/dopa decarboxylase inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 1 siteGermany
- Study dates
- 23 Nov 2016to 4 Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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.
- Male and female subjects aged 30 years or older.
- Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.
- Disease severity Stages I-IV (modified Hoehn - Yahr staging) at ON.
- Treated with three to seven daily doses of L-dopa/DDCI or L-dopa/DDCI/entacapone, which can include a slow-release formulation.
- Signs of "wearing-off" phenomenon according to the 9-Symptom Wearing-off Questionnaire (WOQ-9), despite optimal anti-PD therapy (based on the investigator's judgement). The wearing-off phenomenon has to be confirmed clinically by the investigator.
- For females: Postmenopausal for at least two years or surgically sterile for at least six months before screening.
Who cannot join
- Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
- Severe OFF periods. Patients with rare and/or short unpredictable OFF periods are eligible.
- Previous or current use of tolcapone and/or OPC.
- Treatment with monoamine oxidase inhibitors (MAO-A and MAO-B; except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day or safinamide up to 100 mg/day) within the month before screening.
- Concomitant treatment with entacapone.
- Use of any other investigational medicinal product (IMP), currently or within the three months (or within five half-lives of the IMP, whichever is longer) before screening.
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- Any medical condition that might place the subject at increased risk or interfere with assessments.
- 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 ingredients of IMP (including lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption).
- History of neuroleptic malignant syndrome (NMS) or non-traumatic rhabdomyolysis.
- Severe hepatic impairment (Child-Pugh Class C).
- For females: Breastfeeding.
- Employees of the investigator, trial centre, sponsor, clinical research organisation and trial consultants, when employees are directly involved in the trial or other studies under the direction of this investigator or trial centre, and their family members.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Carl Gustav Carus at the TU Dresden, Neurological University Clinic
Dresden, 01307
About this study
Official title: Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations
The purpose of this study is to evaluate the change in subject's condition according to the Investigator's Global Assessment of Change after three months of treatment with 50 mg opicapone once daily in a heterogeneous patient population reflecting daily clinical practice.
Read the detailed description
This is a prospective, open-label, uncontrolled, single-group, multi-centre trial in Parkinson's disease (PD) patients with wearing-off motor fluctuations.
At screening/baseline (Visit 1, Day 1) all subjects will start treatment with 50 mg opicapone (OPC) once daily for a 3-month period in addition to their current treatment with levodopa/dopa decarboxylase inhibitor (L-dopa/DDCI). Subjects treated with L-dopa/DDCI/entacapone before trial entry will discontinue entacapone treatment at this visit. Subjects treated with L-dopa/DDCI/tolcapone before trial entry will not be eligible, as well as those previously treated with OPC. Subjects treated with dopamine agonists will be eligible.
OPC enhances the effects of L-dopa. Hence, it may be necessary to reduce the subject's L-dopa/DDCI dose within the first days or weeks of OPC treatment by extending the dosing intervals and/or reducing the amount of L-dopa/DDCI per dose. Therefore, on Day 15 ±3 (Visit 2) the investigator will call the subject to ask for adverse events (AE, e.g. dopaminergic AEs) and if required, to reduce the L-dopa/DDCI dose. The investigator may increase or decrease the total daily L-dopa/DDCI dose according to the subject's condition throughout the trial, except at Visit 1. At the Visit 1 the L-dopa dose should not be changed.
Further visits will be performed on Day 30 ±4 (Visit 3) and on Day 90 ±4 (Visit 4). Subjects who discontinue trial participation prematurely will be asked to come to the site for an early discontinuation visit (EDV).
In addition to the scheduled visits, subjects may be asked to call or to return to the trial site, or subjects may be called by the investigator for assessment of safety data or adjustment of L-dopa/DDCI dose (unscheduled visits).
At Visit 4 (or EDV, if applicable) the investigator will arrange for the subject's subsequent PD treatment, i.e. either prescribe further OPC or switch to another treatment.
- Being tested
- BIA 9-1067, levodopa/dopa decarboxylase inhibitor
- Keywords
- Ongentys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 9-1067Drug
Also called Ongentys, Opicapone
Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily at bedtime, at least one hour before or after the last daily dose of L-dopa/DDCI.
levodopa/dopa decarboxylase inhibitorDrug
Also called L-dopa/DDCI
OPC enhances the effects of L-dopa. Hence, it may be necessary to reduce the subject's L-dopa/DDCI dose within the first days or weeks of OPC treatment by extending the dosing intervals and/or reducing the amount of L-dopa/DDCI per dose
| Study group | Role | What they receive |
|---|---|---|
| Opicapone (BIA 9-1067) 50 mg | Experimental | Total duration of trial participation and treatment: three months. All subjects will start treatment with 50 mg opicapone (OPC) once daily for a 3-month period in addition to their current treatment with levodopa/dopa decarboxylase inhibitor (L-dopa/DDCI) Receives: Drug: BIA 9-1067; Drug: levodopa/dopa decarboxylase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment of Change
Measured: Through study completion, an average of three months
Secondary outcomes (10)
Change in L-dopa total daily dose
Measured: Through study completion, an average of 3 months
percentage of subjects with change in number of daily L-dopa doses
Measured: Through study completion, an average of 3 months
percentage of subjects with change in L-dopa single dose (SD)
Measured: Through study completion, an average of 3 months
percentage of subjects with stable L-dopa regimen
Measured: Through study completion, an average of 3 months
percentage of subjects for whom OPC will be prescribed
Measured: Through study completion, an average of 3 months
percentage of subjects who stopped treatment with OPC
Measured: Through study completion, an average of 3 months
Subject's Global Assessment of Change at Visit 3
Measured: Through study completion, an average of 3 months
Subject's Global Assessment of Change at Visit 4
Measured: Through study completion, an average of 3 months
Absolute values in unified Parkinson's disease rating scale (UPDRS) scale
Measured: Through study completion, an average of 3 months
Change from baseline to Visit 4 in UPDRS scale
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start23 Nov 2016
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease With Wearing-off Motor FluctuationsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847442
- Sponsor's protocol ID
- BIA-OPC-401
- Other IDs
- 2016-002391-27, 2016
- Acronym
- OPTIPARK
- Status last verified
- Oct 2018
- First submitted
- 21 Jul 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schofield C, Chaudhuri KR, Carroll C, Sharma JC, Pavese N, Evans J, Foltynie T, Reichmann H, Zurowska L, Soares-da-Silva P, Lees A. Opicapone in UK clinical practice: effectiveness, safety and cost analysis in patients with Parkinson's disease. Neurodegener Dis Manag. 2022 Apr;12(2):77-91. doi: 10.2217/nmt-2021-0057. Epub 2022 Mar 21.
PubMed 35313124Reichmann H, Lees A, Rocha JF, Magalhaes D, Soares-da-Silva P; OPTIPARK investigators. Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: the OPTIPARK open-label study. Transl Neurodegener. 2020 Mar 4;9(1):9. doi: 10.1186/s40035-020-00187-1.
PubMed 32345378
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations
- ClinicalTrials.gov ID
- NCT02847442
- Acronym / sponsor ID
- OPTIPARK / BIA-OPC-401
- Keywords
- Ongentys
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the change in subject's condition according to the Investigator's Global Assessment of Change after three months of treatment with 50 mg opicapone once daily in a heterogeneous patient population reflecting daily clinical practice.
Detailed description
This is a prospective, open-label, uncontrolled, single-group, multi-centre trial in Parkinson's disease (PD) patients with wearing-off motor fluctuations.
At screening/baseline (Visit 1, Day 1) all subjects will start treatment with 50 mg opicapone (OPC) once daily for a 3-month period in addition to their current treatment with levodopa/dopa decarboxylase inhibitor (L-dopa/DDCI). Subjects treated with L-dopa/DDCI/entacapone before trial entry will discontinue entacapone treatment at this visit. Subjects treated with L-dopa/DDCI/tolcapone before trial entry will not be eligible, as well as those previously treated with OPC. Subjects treated with dopamine agonists will be eligible.
OPC enhances the effects of L-dopa. Hence, it may be necessary to reduce the subject's L-dopa/DDCI dose within the first days or weeks of OPC treatment by extending the dosing intervals and/or reducing the amount of L-dopa/DDCI per dose. Therefore, on Day 15 ±3 (Visit 2) the investigator will call the subject to ask for adverse events (AE, e.g. dopaminergic AEs) and if required, to reduce the L-dopa/DDCI dose. The investigator may increase or decrease the total daily L-dopa/DDCI dose according to the subject's condition throughout the trial, except at Visit 1. At the Visit 1 the L-dopa dose should not be changed.
Further visits will be performed on Day 30 ±4 (Visit 3) and on Day 90 ±4 (Visit 4). Subjects who discontinue trial participation prematurely will be asked to come to the site for an early discontinuation visit (EDV).
In addition to the scheduled visits, subjects may be asked to call or to return to the trial site, or subjects may be called by the investigator for assessment of safety data or adjustment of L-dopa/DDCI dose (unscheduled visits).
At Visit 4 (or EDV, if applicable) the investigator will arrange for the subject's subsequent PD treatment, i.e. either prescribe further OPC or switch to another treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opicapone (BIA 9-1067) 50 mg | Experimental | Drug: BIA 9-1067, Drug: levodopa/dopa decarboxylase inhibitorTotal duration of trial participation and treatment: three months. All subjects will start treatment with 50 mg opicapone (OPC) once daily for a 3-month period in addition to their current treatment with levodopa/dopa decarboxylase inhibitor (L-dopa/DDCI) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to comprehend and willing to sign an informed consent form.
- Male and female subjects aged 30 years or older.
- Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.
- Disease severity Stages I-IV (modified Hoehn - Yahr staging) at ON.
- Treated with three to seven daily doses of L-dopa/DDCI or L-dopa/DDCI/entacapone, which can include a slow-release formulation.
Key exclusion criteria (15 listed)
- Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
- Severe OFF periods. Patients with rare and/or short unpredictable OFF periods are eligible.
- Previous or current use of tolcapone and/or OPC.
- Treatment with monoamine oxidase inhibitors (MAO-A and MAO-B; except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day or safinamide up to 100 mg/day) within the month before screening.
- Concomitant treatment with entacapone.
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 |
|---|---|---|
| BIA 9-1067Also: Ongentys, OpicaponeOpicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily at bedtime, at least one hour before or after the last daily dose of L-dopa/DDCI. | Drug | Opicapone (BIA 9-1067) 50 mg |
| levodopa/dopa decarboxylase inhibitorAlso: L-dopa/DDCIOPC enhances the effects of L-dopa. Hence, it may be necessary to reduce the subject's L-dopa/DDCI dose within the first days or weeks of OPC treatment by extending the dosing intervals and/or reducing the amount of L-dopa/DDCI per dose | Drug | Opicapone (BIA 9-1067) 50 mg |
Primary outcome
Investigator's Global Assessment of Change
Time frame: Through study completion, an average of three months
10 secondary outcomes
Change in L-dopa total daily dose
Time frame: Through study completion, an average of 3 months
percentage of subjects with change in number of daily L-dopa doses
Time frame: Through study completion, an average of 3 months
percentage of subjects with change in L-dopa single dose (SD)
Time frame: Through study completion, an average of 3 months
percentage of subjects with stable L-dopa regimen
Time frame: Through study completion, an average of 3 months
percentage of subjects for whom OPC will be prescribed
Time frame: Through study completion, an average of 3 months
percentage of subjects who stopped treatment with OPC
Time frame: Through study completion, an average of 3 months
Subject's Global Assessment of Change at Visit 3
Time frame: Through study completion, an average of 3 months
Subject's Global Assessment of Change at Visit 4
Time frame: Through study completion, an average of 3 months
Absolute values in unified Parkinson's disease rating scale (UPDRS) scale
Time frame: Through study completion, an average of 3 months
Change from baseline to Visit 4 in UPDRS scale
Time frame: Through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 35313124Schofield C, Chaudhuri KR, Carroll C, Sharma JC, Pavese N, Evans J, Foltynie T, Reichmann H, Zurowska L, Soares-da-Silva P, Lees A. Opicapone in UK clinical practice: effectiveness, safety and cost analysis in patients with Parkinson's disease. Neurodegener Dis Manag. 2022 Apr;12(2):77-91. doi: 10.2217/nmt-2021-0057. Epub 2022 Mar 21.
- Derived from this study: PubMed 32345378Reichmann H, Lees A, Rocha JF, Magalhaes D, Soares-da-Silva P; OPTIPARK investigators. Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: the OPTIPARK open-label study. Transl Neurodegener. 2020 Mar 4;9(1):9. doi: 10.1186/s40035-020-00187-1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BIA 9-1067 and levodopa/dopa decarboxylase inhibitor in people with Parkinson's Disease With Wearing-off Motor Fluctuations, run by Bial - Portela C S.A. at 1 site in Germany.
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 7 inclusion and 15 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 15 Oct 2018. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigator's Global Assessment of Change (time frame: Through study completion, an average of three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847442, which also lists 2 linked publications.
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 15 Oct 2018.