Back to resultsEfficacy and Safety of Opicapone in Clinical Practice (OPTIPARK)
Primary Purpose
Parkinson's Disease With Wearing-off Motor Fluctuations
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
BIA 9-1067
levodopa/dopa decarboxylase inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease With Wearing-off Motor Fluctuations focused on measuring Ongentys
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- University Hospital Carl Gustav Carus at the TU Dresden, Neurological University Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Opicapone (BIA 9-1067) 50 mg
Arm Description
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)
Outcomes
Primary Outcome Measures
Investigator's Global Assessment of Change
Secondary Outcome Measures
Change in L-dopa total daily dose
percentage of subjects with change in number of daily L-dopa doses
percentage of subjects with change in L-dopa single dose (SD)
percentage of subjects with stable L-dopa regimen
percentage of subjects for whom OPC will be prescribed
percentage of subjects who stopped treatment with OPC
Subject's Global Assessment of Change at Visit 3
Subject's Global Assessment of Change at Visit 4
Absolute values in unified Parkinson's disease rating scale (UPDRS) scale
Change from baseline to Visit 4 in UPDRS scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02847442
Brief Title
Efficacy and Safety of Opicapone in Clinical Practice
Acronym
OPTIPARK
Official Title
Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 23, 2016 (Actual)
Primary Completion Date
July 4, 2018 (Actual)
Study Completion Date
July 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease With Wearing-off Motor Fluctuations
Keywords
Ongentys
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
518 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opicapone (BIA 9-1067) 50 mg
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
BIA 9-1067
Other Intervention Name(s)
Ongentys, Opicapone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
levodopa/dopa decarboxylase inhibitor
Other Intervention Name(s)
L-dopa/DDCI
Intervention Description
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
Primary Outcome Measure Information:
Title
Investigator's Global Assessment of Change
Time Frame
Through study completion, an average of three months
Secondary Outcome Measure Information:
Title
Change in L-dopa total daily dose
Time Frame
Through study completion, an average of 3 months
Title
percentage of subjects with change in number of daily L-dopa doses
Time Frame
Through study completion, an average of 3 months
Title
percentage of subjects with change in L-dopa single dose (SD)
Time Frame
Through study completion, an average of 3 months
Title
percentage of subjects with stable L-dopa regimen
Time Frame
Through study completion, an average of 3 months
Title
percentage of subjects for whom OPC will be prescribed
Time Frame
Through study completion, an average of 3 months
Title
percentage of subjects who stopped treatment with OPC
Time Frame
Through study completion, an average of 3 months
Title
Subject's Global Assessment of Change at Visit 3
Time Frame
Through study completion, an average of 3 months
Title
Subject's Global Assessment of Change at Visit 4
Time Frame
Through study completion, an average of 3 months
Title
Absolute values in unified Parkinson's disease rating scale (UPDRS) scale
Time Frame
Through study completion, an average of 3 months
Title
Change from baseline to Visit 4 in UPDRS scale
Time Frame
Through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
University Hospital Carl Gustav Carus at the TU Dresden, Neurological University Clinic
City
Dresden
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35313124
Citation
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.
Results Reference
derived
PubMed Identifier
32345378
Citation
Reichmann 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. Erratum In: Transl Neurodegener. 2020 Apr 28;9(1):14.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Opicapone in Clinical Practice
We'll reach out to this number within 24 hrs