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    Summary
    EudraCT Number:2020-001175-32
    Sponsor's Protocol Code Number:BIA-91067-404
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-09-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-001175-32
    A.3Full title of the trial
    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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson’s disease
    A.3.2Name or abbreviated title of the trial where available
    OpiCapone Effect on motor fluctuations and pAiN (OCEAN)
    A.4.1Sponsor's protocol code numberBIA-91067-404
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBial - Portela & Ca, S.A.
    B.1.3.4CountryPortugal
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBial - Portela & Ca, S.A.
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBial - Portela & Ca, S.A.
    B.5.2Functional name of contact pointPharmD Raquel Costa
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. da Siderurgia Nacional
    B.5.3.2Town/ cityCoronado (S. Romão e S. Mamede)
    B.5.3.4CountryPortugal
    B.5.4Telephone number+351229866100
    B.5.5Fax number+351229866192
    B.5.6E-mailRaquel.Costa@bial.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ongentys®
    D.2.1.1.2Name of the Marketing Authorisation holderBial - Portela & Ca, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOpicapone 50 mg hard capsules
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOpicapone
    D.3.9.1CAS number 923287-50-7
    D.3.9.2Current sponsor codeBIA 9-1067
    D.3.9.4EV Substance CodeSUB130629
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease patients with wearing-off motor fluctuations and associated pain.
    E.1.1.1Medical condition in easily understood language
    Parkinson’s disease patients with associated movement disorders and pain.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of 50 mg opicapone when administered with the existing treatment of L-dopa plus a DDCI, in PD patients with end-of-dose motor fluctuations and associated pain
    E.2.2Secondary objectives of the trial
    •To investigate the efficacy of opicapone 50 mg in reducing further symptoms
    •To investigate the safety and tolerability of opicapone 50 mg once daily
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit 1 (Screening), patients must meet ALL of the following criteria:
    1. Able to comprehend and willing to sign an informed consent form and to comply with all
    aspects of the study.
    2. Male or female patients aged 30 years or older.
    3. Experiencing PD associated pain for at least 4 weeks prior to V1.
    4. 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).
    5. Disease severity Stages I-III (modified Hoehn & Yahr staging) at ON.
    6. 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.
    7. 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.
    8. 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).
    9. 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).
    10. Domain 3 of KPPS ≥ 12.
    11. 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.
    At Visit 2b (Baseline), patients must meet ALL of the following criteria:
    12. 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.
    13. 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.
    14. 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).
    15. Domain 3 of KPPS ≥ 12.
    16. Adequate compliance to relevant (PD and pain related) concomitant medication during the
    screening period (based on the investigator’s judgment).
    E.4Principal exclusion criteria
    Criterion:
    1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic]
    parkinsonism, Parkinson-plus syndrome).
    2. Severe and/or unpredictable OFF periods, according to investigator judgement.
    3. Major/prominent non-PD-related pain (e.g. due to malignant disease).
    4. 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.
    5. Previous or planned (during the entire study duration) L-dopa/carbidopa intestinal gel
    infusion, brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
    6. Treatment with apomorphine within the last 4 weeks before V1 or likely to be needed at
    any time until V6.
    7. Previous or current use of opicapone.
    8. Use of any other IP, currently or within the 3 months (or within 5 half-lives of the IP,
    whichever is longer) before V1.
    9. Past (within the past year) or present history of suicidal ideation or suicide attempts.
    10. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or
    nicotine.
    11. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
    12. Known hypersensitivity to the excipients of IP (including lactose intolerance, galactose
    intolerance, Lapp lactase deficiency or glucose-galactose malabsorption) or of rescue
    medication.
    13. History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis.
    14. History of severe hepatic impairment (Child-Pugh Class C).
    15. Previous history of psychosis or psychiatric disorders, including severe major depression.
    16. Any medical condition that might place the patient at increased risk or interfere with
    assessments.
    17. For females: Pregnant or breastfeeding.
    18. 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.
    19. Persons committed to an institution by virtue of an order issued either by the judicial or
    other authorities.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Domain 3 (fluctuation-related pain) of King’s Parkinson’s Disease Pain Scale (KPPS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    E.5.2Secondary end point(s)
    1.Change from baseline in Domain B (anxiety) of Movement Disorder Society-sponsored Non-motor Rating Scale (MDS-NMS) (Key secondary endpoint)
    2.Change from baseline in Domain A (depression) of MDS-NMS
    3.Change from baseline in Domain K (sleep and wakefulness) of MDS-NMS
    4.Change from baseline in total score of MDS-NMS
    5.Change from baseline in Domain 4 (nocturnal pain) of KPPS
    6.Change from baseline in total score of KPPS
    7.Change from baseline in Movement Disorder Society-sponsored Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III and IV
    8.Change from baseline in Parkinson’s Disease Questionnaire (PDQ-8)
    9.Clinical Global Impression of Change (CGIC)
    10.Patient’s Global Impression of Change (PGIC)
    11.Change from baseline in functional status via Hauser’s PD diary
    12.Changes from baseline in morning dystonia
    13.Frequency of use of rescue medication
    14.Incidence of adverse events (AEs) including serious adverse events (SAEs)
    15.Changes from baseline in vital signs
    16.Changes from baseline in physical and neurological examinations
    17.Changes from baseline in routine laboratory parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    Czechia
    Germany
    Italy
    Poland
    Portugal
    Spain
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 88
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 176
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    the investigator will arrange for the patient’s subsequent treatment, i.e. patients will be treated with the most appropriate individual local standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-16
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