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    Summary
    EudraCT Number:2019-001657-42
    Sponsor's Protocol Code Number:AKST4290-211
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-01
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2019-001657-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the
    Efficacy and Safety of AKST4290 in Subjects with Parkinson's Disease on
    Stable Dopaminergic Treatment.
    Randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie na zhodnotenie účinnosti a bezpečnosti AKST4290 u účastníkov s Parkinsonovou chorobou na stabilnej dopaminergnej liečbe.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn how well the drug AKST4290 works and how safe
    AKST4290 is in people who have Parkinson's disease that are taking
    dopamine based medication.
    Štúdia s cieľom zistiť, ako dobre liek AKST4290 účinkuje a ako je bezpečný u ľudí s Parkinsonovou chorobou, ktorí uživajú lieky na báze dopamínu.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberAKST4290-211
    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 SponsorAlkahest, Inc.
    B.1.3.4CountryUnited States
    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 supportAlkahest, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlkahest, Inc.
    B.5.2Functional name of contact pointEsther Rawner
    B.5.3 Address:
    B.5.3.1Street Address125 Shoreway Road, Suite D
    B.5.3.2Town/ citySan Carlos
    B.5.3.3Post codeCA 94070
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16508010469
    B.5.5Fax number+16508010480
    B.5.6E-mailerawner@alkahest.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 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 nameAKST4290
    D.3.2Product code AKST4290
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAKST4290
    D.3.9.1CAS number 1251528-23-0
    D.3.9.2Current sponsor codeAKST4290
    D.3.9.3Other descriptive name2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB191358
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    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
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease is a disease that affects the brain and nerves, which causes the patients muscles to shake and causes movement to be rigid and imprecise. The condition gets worse over time.
    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 assess the effects of AKST4290 on motor function in the practically defined off-medication state in subjects with Parkinson's Disease
    E.2.2Secondary objectives of the trial
    To assess the safety of AKST4290 in subjects with Parkinson's Disease as well as the potential effects on clinical function, cognition and activities of daily living
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 50-80 years at time of enrollment, inclusive.
    2. Diagnosis of clinically established or clinically probable Parkinson's
    Disease (PD) according to MDS-PD criteria with at least 1 year of PD
    symptoms.
    3. Modified Hoehn and Yahr ≤2.5.
    4. Have notable motor worsening during off-medication state.
    5. Must be on stable dopaminergic therapy.
    6. If on medications for cognition,must be on stable dosage for at least 8
    weeks.
    7. If on antidepressant medications or neuroleptic medications, must be
    on stable dosage for at least 8 weeks prior to enrollment.
    8. Female subjects must not be pregnant or breastfeeding. Women of
    childbearing potential (WOCBP) must have a negative pregnancy test at
    Screening. WOCBP must agree to use highly effective contraception
    which includes combined (estrogen and progestogen containing)
    hormonal contraception associated with inhibition of ovulation (oral,
    intravaginal, transdermal), progestogen-only hormonal contraception
    associated with inhibition of ovulation (oral, injectable, implantable),
    intrauterine device, intrauterine hormone-releasing system, bilateral
    tubal occlusion or vasectomized partner prior to study entry. A woman is
    considered of childbearing potential following menarche and until
    becoming postmenopausal (no menses for at least 2 years without an
    alternative cause). Should a woman become pregnant or suspect she is
    pregnant while she or her partner is participating in the study, she
    should inform her treating physician immediately. Male subjects must be
    willing to use a barrier method contraception.
    09. The subject must be able to understand the procedures and agree to
    complete the required assessments.
    10. Provide a signed and dated informed consent form in accordance
    with local regulations and/or IRB/IEC guidelines.
    E.4Principal exclusion criteria
    1. Secondary or atypical parkinsonian syndromes.
    2. Medical history or condition:
    • Uncontrolled diabetes mellitus.
    • Myocardial infarction or stroke within 12 months of screening.
    • Significant cardiac arrhythmia.
    • Active bleeding disorder.
    • Concomitant use of warfarin or oral anticoagulation therapy.
    • Major surgery within 1 month of screening or planned within the study.
    • Active liver disease.
    • Uncontrolled high blood pressure.
    • Known infection with hepatitis B virus, hepatitis C virus, or human
    immunodeficiency virus (HIV).
    3. Prior treatment within 2 weeks or planned use of potent cytochrome
    P450 3A4/5 (CYP3A4/5) or P glycoprotein (P-gp) inhibitors or inducers
    during the study)
    4. Current or planned concomitant use of drugs that are P-gp sensitive
    substrates/P-gp narrow therapeutic index (NTI) substrates (e.g., some
    factor Xa inhibitors)
    5. Current or planned concomitant use of warfarin.
    6. Renal function as defined by estimated glomerular filtration rate
    (eGFR) <45 mL/min/1.73 m2 using the Modification of Diet in Renal
    Disease (MDRD) study equation.
    7. Use of any nonselective monoamine oxidase (MAO) inhibitors.
    8. Current or planned concomitant use of clozapine
    9. History of any brain surgery for Parkinson's Disease .
    10. Use of systemic steroids.
    11. History of any brain surgery for Parkinson's Disease .
    12. Use of systemic steroids.
    13. Based on ECG reading, subjects with a risk of QT prolongation
    including:
    • The use of concomitant medications known to prolong the QT/QTc
    interval.
    14. Significant medical conditions
    15. Malignancy for which the patient has undergone resection, radiation
    or chemotherapy within past 5 years.
    16. Concurrent participation in another interventional clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline (Day 1) in motor function during the practically defined off-medication state, defined as greater than or equal to 12 hours off levodopa as measured by the MDS-UPDRS Part 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 (Day 84)
    E.5.2Secondary end point(s)
    1. Incidence of treatment-emergent Adverse Events and Serious Adverse Events identidied by Medical Dictionary for Regulatory Activities Preferred Term (MedDRA PT) and grouped by MedDRA System Organ Class (SOC)
    2. Incidence of abnormalities or clinically-significant changes from Baseline in laboratory test data, vital sign measurements, and electrocardiogram's
    3. Change from baseline (Day 1) in clinical function, motor function, and activities of daily living at Week 12 (Day 84) during the on-medication state as assessed by the following:
    a. Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts 1-4
    b. Montreal Cognitive Assessment (MoCA)
    c. Schwab and England Activities of Daily Living (SE-ADL) Scale
    d. Clinical Impression of Severity Index – Parkinson’s Disease (CISI-PD)
    e. Parkinson’s Disease Quality of Life Questionnaire-39 (PDQ-39)
    f. Sheehan-Suicidality Tracking Scale (S-STS)
    g. 10-meter timed walk
    h. Hauser 3-Day Patient Diary
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 (Day 84)
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Estonia
    Germany
    Hungary
    Poland
    United States
    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 years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 120
    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)
    Each investigator, in collaboration with the subject's ususal healthcare provider, is responsible for ensuring that consideration has been given to the post-study care of each subject
    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 Kompetenznetz Parkinson e.V. Koordination (German Parkinson's Disease Network)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-10
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