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    Summary
    EudraCT Number:2016-002391-27
    Sponsor's Protocol Code Number:BIA-OPC-401
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-05
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2016-002391-27
    A.3Full title of the trial
    Efficacy and safety of opicapone in clinical practice in Parkinson’s Disease patients with wearing-off motor fluctuations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OPTIPARK
    A.4.1Sponsor's protocol code numberBIA-OPC-401
    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 pointGlobal Medical Affairs Manager
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. da Siderurgia Nacional
    B.5.3.2Town/ cityCoronado S. Romao e S. Mamede
    B.5.3.3Post code4745-457
    B.5.3.4CountryPortugal
    B.5.4Telephone number+351 229866100
    B.5.5Fax number+351 229866192
    B.5.6E-mailBasilio.Hernandez@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 AuthorisationGermany
    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.3.11 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease (PD) patients with wearing-off motor fluctuations
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    To investigate the safety of opicapone 50 mg once daily in clinical practice.
    To investigate the efficacy of opicapone 50 mg once daily in clinical practice.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to comprehend and willing to sign an informed consent form.
    2. Male and female subjects aged 30 years or older.
    3. Diagnosed with idiopathic PD according to the UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria.
    4. Disease severity Stages I-IV (modified Hoehn &Yahr staging) at ON.
    5. Treated with three to seven daily doses of L-dopa/DDCI or L-dopa/DDCI/entacapone, which can include a slow-release formulation.
    6. 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.
    7. For females: Postmenopausal for at least two years or surgically sterile for at least six months before screening.
    E.4Principal exclusion criteria
    1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome).
    2. Severe OFF periods. Patients with rare and/or short unpredictable OFF periods are eligible.
    3. Previous or current use of tolcapone and/or OPC.
    4. Treatment with monoamine oxidase MAO-A and MAO-B inhibitors (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.
    5. Concomitant treatment with entacapone.
    6. 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..
    7. Any medical condition that might place the subject at increased risk or interfere with assessments.
    8. Past (within the past year) or present history of suicidal ideation or suicide attempts.
    9. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine.
    10. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
    11. Known hypersensitivity to the ingredients of IMP (including lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption).
    12. History of neuroleptic malignant syndrome (NMS) or non-traumatic rhabdomyolysis.
    13. Severe hepatic impairment (Child-Pugh Class C).
    14. For females: Breastfeeding.
    15. 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.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Investigator’s Global Assessment of Change at Visit 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 4
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    Change in L-dopa total daily dose from baseline (Visit 1) to each on-site visit.
    Number and percentage of subjects with change in number of daily L-dopa doses from baseline (Visit 1) at each on-site visit.
    Number and percentage of subjects with change in L-dopa single dose (SD) from baseline (Visit 1) at each on-site visit.
    Number and percentage of subjects with stable L-dopa regimen between Visit 3 and Visit 4.
    Number and percentage of subjects for whom OPC will be prescribed further after trial completion.
    Number and percentage of subjects who stopped treatment with OPC before trial completion or at Visit 4 due to:
     AEs
     Lack of efficacy
     Other reasons
     Investigator’s Global Assessment of Change at Visit 3.
     Subject’s Global Assessment of Change at Visit 3 and Visit 4.
    Absolute values and, if applicable, change from baseline at each on-site visit in WOQ-9.
    Absolute values and, if applicable, change from baseline to Visit 4:
     UPDRS I mentation, behaviour, and mood at ON stage
     UPDRS II (activities of daily living, ADL) at OFF stage
     UPDRS II (ADL) plus III (motor function) during the ON stage
     UPDRS IV at ON stage
     PDQ-8
     NMSS.
    Secondary safety endpoints:
    Incidence of AEs including SAEs.
    General safety information (vital signs, physical and neurological examinations).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 3 and Visit 4
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 concerned80
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state440
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 550
    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)
    None
    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 Decision2016-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-04
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