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    Summary
    EudraCT Number:2019-001566-15
    Sponsor's Protocol Code Number:EIP19-NFD-501
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-22
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-001566-15
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB)
    Een dubbelblind, placebogecontroleerd, 16 weken durend onderzoek naar de cognitieve effecten van de orale P38-α-kinase-inhibitor neflamapimod bij dementie met Lewy-lichaampjes (DLB)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 16-Week Study to assess effects of Neflamapimod in Subjects with Dementia with Lewy Bodies (DLB)
    A.4.1Sponsor's protocol code numberEIP19-NFD-501
    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 SponsorEIP Pharma 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 supportEIP Pharma Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials Limited
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Waterfront House, Beeston Business Park
    B.5.3.2Town/ cityBeeston, Nottingham
    B.5.3.3Post codeNG9 1LA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441159567711
    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 nameNeflamapimod
    D.3.2Product code VX-745
    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 INNNeflamapimod
    D.3.9.1CAS number 209410-46-8
    D.3.9.2Current sponsor codeVX-745
    D.3.9.3Other descriptive nameNeflamapimod
    D.3.9.4EV Substance CodeSUB171442
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Dementia with Lewy Bodies (DLB)
    E.1.1.1Medical condition in easily understood language
    DLB is a brain disease that slowly destroys brain cells and has its worst effects on the areas of brain that control memory, attention, motor function and is also associated with sleep disturbances
    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 10067889
    E.1.2Term Dementia with Lewy bodies
    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
    The primary objective is to evaluate the effect of neflamapimod on cognitive function as assessed in a study-specific Neuropsychological Test Battery (NTB) comprised of:
    •Cogstate Detection test (DET)
    •Cogstate Identification test (IDN)
    •Cogstate One Card Learning test (OCL)
    •Cogstate One Back test (ONB)
    •Letter Fluency Test
    •Category Fluency Test (CFT)
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    •Evaluate the effects of neflamapimod on informant/caretaker evaluation of cognition and function, as assessed by the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
    •Assess the effects of neflamapimod on general cognition, as assessed by the Mini Mental State Examination (MMSE)
    •Assess the effects of neflamapimod on episodic memory, as assessed by the International Shopping List Test (ISLT).
    •Assess the effects of neflamapimod on select domains of the 10-item Neuropsychiatric Inventory (NPI-10), including depression (dysphoria), anxiety, hallucinations, and agitation/aggression.
    •Evaluate the effects of neflamapimod on motor function as assessed by the Timed Up and Go Test (TUG).
    •Evaluate the effects of neflamapimod on quantitative electroencephalography (EEG) parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Men and women aged ≥55 years.
    2.Subject or subject’s legally authorized representative is willing and able to provide written informed consent.
    3.Probable DLB and identified cognitive deficits, according to current consensus criteria (McKeith et al, 2017), specifically one core clinical feature and a positive DaTscan. If a negative DaTscan, but the subject has historical PSG-verified RBD, the subject would also qualify.
    4.MMSE score of 15-28, inclusive, during Screening.
    5.Currently receiving cholinesterase inhibitor therapy, having received such therapy for greater than 3 months and on a stable dose for at least 6 weeks at the time of randomization. Except for reducing the dose for tolerability reasons, the dose of cholinesterase inhibitor may not be modified during the study.
    6.Normal or corrected eye sight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
    7.No history of learning difficulties that may interfere with their ability to complete the cognitive tests.
    8.Must have reliable informant or caregiver.
    E.4Principal exclusion criteria
    1.Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB, including, but not limited to, post-stroke dementia, vascular dementia, Alzheimer’s disease (AD), or Parkinson’s disease (PD).
    2.Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the C-SSRS, or history of suicide attempt in previous 2 years, or, in the Investigator’s opinion, at serious risk of suicide.
    3.Ongoing major and active psychiatric disorder and/or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements.
    4.Diagnosis of alcohol or drug abuse within the previous 2 years.
    5.Poorly controlled clinically significant medical illness, such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety.
    6.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized Ratio (INR) >1.5.
    7.Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection.
    8.Participated in a study of an investigational drug less than 3 months or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study.
    9.History of previous neurosurgery to the brain.
    10.If male with female partner(s) of child-bearing potential, unwilling or unable to adhere to contraception requirements specified in the protocol.
    11.If female who has not has not reached menopause >1 year previously or has not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy, has a positive pregnancy test result during Screening and/or is unwilling or unable to adhere to the contraception requirements specified in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the composite score of the NTB, including assessments of attention, executive function, and visuospatial function in neflamapimod treated-subjects as compared to the placebo-treated subjects
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints at which NTB will be performed: Screening, Baseline (Day 1), W4 (Day 28), W8 (Day 56), W16 (Day 112) and End of Trial visit.
    E.5.2Secondary end point(s)
    •Change in CDR-SB in neflamapimod-treated subjects compared to placebo-recipients.
    •Change in MMSE in neflamapimod-treated subjects compared to placebo-recipients.
    •Change in NPI-10 domains in neflamapimod-treated subjects compared to placebo-recipients.
    •Change in ISLT in neflamapimod-treated subjects compared to placebo-recipients.
    •Change in Timed Up and Go Test.
    •Change in EEG parameters.
    E.5.2.1Timepoint(s) of evaluation of this end point
    CDR-SB: Baseline visit (Day 1), W8 (Day 56), W16 (Day 112) and End of Trial visit.
    MMSE: Screening, Baseline visit (Day 1), W8 (Day 56), W16 (Day 112) and End of Trial visit.
    NPI-10: Screening, Baseline visit (Day 1), W4 (Day 28), W8 (Day 56), W16 (Day 112) and End of Trial visit.
    ISLT: Screening, Baseline (Day 1), W4 (Day 28), W8 (Day 56), W16 (Day 112) and End of Trial visit.
    Timed Up and Go Test: Baseline (Day 1), W8 (Day 56), W15 (Day 112) and ET visit.
    EEG: Baseline visit (Day 1), W16 (Day 112), ET visit.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 States
    Netherlands
    E.8.7Trial has a data monitoring committee Yes
    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
    LSLV
    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 months5
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days7
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 91
    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)
    When the trial has ended, the participants will continue on the standard of care for their condition as determined by their treating physician.
    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 Decision2019-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-14
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