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    EudraCT Number:2017-001673-17
    Sponsor's Protocol Code Number:IRL752C002
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-29
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2017-001673-17
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-centre phase IIa
    study evaluating the safety and tolerability of IRL752 in patients with
    Parkinson's Disease Dementia
    Satunnaistettu, kaksoissokkoutettu, lumelääkekontrolloitu vaiheen IIa monikeskustutkimus, jossa arvioidaan IRL752-valmisteen turvallisuutta ja siedettävyyttä Parkinsonin tautiin liittyvää dementiaa sairastavilla henkilöillä.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and tolerability of IRL752 treatment in
    patients with Parkinson's disease dementia.
    A.4.1Sponsor's protocol code numberIRL752C002
    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 SponsorIntegrative Research Laboratories AB
    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 supportIntegrative Research Laboratories AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Services Turku CRST Oy
    B.5.2Functional name of contact pointCRST Oy
    B.5.3 Address:
    B.5.3.1Street AddressItäinen Pitkäkatu 4B
    B.5.3.2Town/ cityTurku
    B.5.3.3Post code20520
    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 No
    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 nameIRL752
    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 INNIRL752
    D.3.9.1CAS number 1227638-29-0
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Dementia in Parkinson's disease
    E.1.1.1Medical condition in easily understood language
    Parkinson Dementia
    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 LLT
    E.1.2Classification code 10012284
    E.1.2Term Dementia due to Parkinson's disease
    E.1.2System Organ Class 100000014717
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the safety and
    tolerability of IRL752 after repeated dosing in patients with Parkinson's
    Disease Dementia (PDD).
    E.2.2Secondary objectives of the trial
    1. Evaluate the effects of IRL752 on symptoms of Parkinson's disease
    (PD) assessed with UPDRS part 1-4, as compared to placebo.
    2. Evaluate the effects of IRL752 on postural control and walking speed
    assessed with TUG test, as compared to placebo.
    3. Evaluate the effects of IRL752 on freezing of gait assessed with the
    FOGQ, as compared to placebo.
    4. Evaluate the effects of IRL752 on cognitive functions assessed with
    the CANTAB, as compared to placebo.
    5. Evaluate the effects of IRL752 on neuropsychiatric symptoms
    assessed with NPI-12, as compared to placebo.
    6. Evaluate the effects of IRL752 on global function assessed with
    CIBIC-Plus, as compared to placebo.
    7. Evaluate the effects of IRL752 on EEG pattern changes as compared to
    8. Examine the exposure of IRL752 in patients with PDD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female 55-85 years of age.
    2. Female patients must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone (FSH) 25-140 IE/L and estradiaol <200 pmol/L is confirmatory]).
    3. Fertile male patients must be willing to use condom and refrain from donating sperm during the study and ensure that their fertile female partners are using contraceptive methods to prevent pregnancy .
    4. Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria.
    5. Diagnosis of PDD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) criteria, with onset of symptoms of dementia at least two years following the first diagnosis of idiopathic PD.
    6. Mini Mental State Examination (MMSE) score of ≥12 and ≤ 26 at screening.
    7. On a stable regimen of anti-Parkinson's medications for at least 30 days prior to screening (Selegelin not allowed), and willing to continue the same doses and regimens during study participation.
    8. Availability of a responsible caregiver at least four days per week.
    9. Able to cooperate and participate in study related procedures.
    10. Written informed consent for participation in the study given by the patient.
    E.4Principal exclusion criteria
    1. An advanced, severe, or unstable disease of any type that may interfere with the primary and secondary variable evaluations.
    2. A score of 5 (wheelchair bound or bedridden) in the "on"-state on the Modified Hoehn and Yahr Staging (UPDRS Part 5).
    3. A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD.
    4. A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia.
    5. A current diagnosis of probably vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association International pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria.
    6. A current diagnosis of a major depressive episode according to DSM-IV criteria.
    7. A history of stereotaxic brain surgery for PD.
    8. Any history of a clinically relevant heart condition, including prolonged QTc (>450 ms), clinically relevant cardiac arrhythmias, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator.
    9. Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease; symptomatic orthostatic hypotension; hepatic disease; renal failure, history of abnormal renal function; or seizures.
    10. Creatinine clearance <45 ml/min (calculated according to the Cockcroft-Gault formula).
    11. History of severe allergy/hypersensitivity or severe on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL752.
    12. Treatment with Warfarin within three (3) months before study treatment.
    13. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study.
    14. Current or history of alcohol abuse and/or use of drugs of abuse.
    15. Any planned major surgery within the duration of the study.
    16. Any other condition or symptoms preventing the patient from entering the study, according to the Investigator’s judgement.
    E.5 End points
    E.5.1Primary end point(s)
    The primary evaluation parameters are:
    Frequency, seriousness and intensity of AEs
    Physical examination
    ECG recordings
    Vital signs (blood pressure and pulse)
    Safety laboratory measurements
    E.5.1.1Timepoint(s) of evaluation of this end point
    Frequency, seriousness and intensity of AEs – at visit 2-8 and Follow-up.
    Physical examination – at visit 8 and Follow-up.
    ECG recordings – at visit 6, 7 and Follow-up.
    Vital signs (blood pressure and pulse) – at visit 6,8 and Follow-up.
    Safety laboratory measurements – at visit 8 and Follow-up.
    E.5.2Secondary end point(s)
    The secondary evaluation parameters are:
    Change in UPDRS Part 1-4 scores from baseline to end of treatment.
    Change in TUG test from baseline to end of treatment.
    Change in FOGQ score from baseline to end of treatment.
    Change in CANTAB performance from baseline to end of treatment,
    - Motor Screening Task
    - Reaction time
    - Spatial Working Memory Task
    - One Touch Stockings of Cambridge
    Change in NPI-12 scores from baseline (screening) to end of treatment.
    CIBIC-Plus score at end of treatment.
    Change in resting state EEG pattern from baseline to end of treatment.
    Plasma concentrations of IRL752.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change in UPDRS Part 1-4 scores – at visit 7.
    Change in TUG test – at visit 7.
    Change in FOGQ score – at visit 7.
    Change in CANTAB performance – at visit 7.
    Change in NPI-12 scores – at visit 8.
    CIBIC-Plus score – at visit 8.
    Change in resting state EEG pattern – at visit 7.
    Plasma concentrations of IRL752 – at visit 2, 6 and 7.
    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 Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    All SAE's will be followed-up and treated according to daily clinical practice until the patient has recovered, stabilized, or recovered with sequelae. SAEs spontaneously reported by a patient to the Investigator within 30 days after the last follow-up assessment will be handled in the same manner as SAEs occurring during the study. There will be no treatment with IRL752 available after end of study participation.
    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 Decision2017-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-25
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