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    Summary
    EudraCT Number:2020-001175-32
    Sponsor's Protocol Code Number:BIA-91067-404
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-08-07
    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 ConcernedUK - MHRA
    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 evaluate the effect of opicapone 50 mg in the 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 pointRaquel Costa, PharmD
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. da Siderurgia Nacional
    B.5.3.2Town/ cityCoronado (S. Romão e S. Mamede)
    B.5.3.3Post code4745-457
    B.5.3.4CountryPortugal
    B.5.4Telephone number+351 229866100
    B.5.5Fax number+351 229866198
    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 nameOngentys
    D.3.4Pharmaceutical form Capsule, hard
    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-91067
    D.3.9.4EV Substance CodeAS1
    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, hard
    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 result in loss of special nerve cells in the brain. This affects movement, cause tremor and stiffness.
    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 see if Opicapone 50mg has an effect on Parkinson's disease patients who suffer from PD related pain compared to placebo.
    E.2.2Secondary objectives of the trial
    1. To see the effect of opicapone 50 mg in reducing further PD symptoms.
    2. To see if opicapone 50 mg taken once a day is safe and well tolerated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria at Visit 1 (Screening):
    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 screening.
    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 7 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.

    Inclusion Criteria at V2b (Baseline):
    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
    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, deep 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 f 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Germany
    Italy
    Portugal
    Spain
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months0
    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 months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    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, either prescribe further opicapone or swith to another treatment, whatever may be considered the most appropriate individual standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation National Institute for Health Research
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-16
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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