Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-003250-16
    Sponsor's Protocol Code Number:MTI-110
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-06
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-003250-16
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Refractory Chronic Cough
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Chronic Cough with No Apparent Cause
    A.4.1Sponsor's protocol code numberMTI-110
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03282591
    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 SponsorMenlo Therapeutics 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 supportMenlo Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMenlo Therapeutics Inc.
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address200 Cardinal Way, 2nd Floor
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post codeCA 94063
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16504861416
    B.5.5Fax number+16502490205
    B.5.6E-mailpkwon@menlotx.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 nameSerlopitant
    D.3.2Product code VPD-737
    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 INNSerlopitant
    D.3.9.1CAS number 860642-69-9
    D.3.9.2Current sponsor codeVPD-737
    D.3.9.3Other descriptive nameSERLOPITANT
    D.3.9.4EV Substance CodeSUB130838
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Refractory Chronic Cough
    E.1.1.1Medical condition in easily understood language
    Chronic cough with no apparent cause
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066656
    E.1.2Term Chronic cough
    E.1.2System Organ Class 100000004855
    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 effectiveness of serlopitant for the treatment of refractory chronic cough after 12 weeks of treatment in reducing 24-hour objective cough frequency.
    E.2.2Secondary objectives of the trial
    To evaluate the effectiveness of serlopitant as compared to placebo after 4 and 8 weeks of treatment in reducing 24-hour objective cough frequency
    To evaluate the effectiveness of serlopitant as compared to placebo after 4, 8 and 12 weeks of treatment in reducing awake objective cough frequency
    To evaluate the effectiveness of serlopitant as compared to placebo after 4, 8 and 12 weeks of treatment in reducing sleep objective cough frequency
    To evaluate the effectiveness of serlopitant in:
    Reducing the cough severity measured by a Visual Analog Scale (VAS)
    Improving cough-specific quality of life (LCQ)
    To assess the safety and tolerability of repeated oral doses of serlopitant in subjects with treatment refractory chronic cough
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Females and males between 18 and 80 years of age inclusive, at Screening
    2. Chest radiograph or CT Thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough in the opinion of the Principal Investigator and/or Menlo Therapeutics Medical Monitor
    3. Have a diagnosis of treatment refractory chronic cough or unexplained cough for at least one year
    4. At Screening have a score of ≥ 40mm on the Cough Severity VAS
    5. At Baseline (Day 0) have a score of ≥ 40mm on the Cough Severity VAS
    6. All female subjects who are of childbearing potential must practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of < 1% per year) from the time of the initial Screening visit until 4 weeks after last dose of study drug.
    7. Have provided written informed consent
    8. Are willing and able to comply with all aspects of the protocol
    E.4Principal exclusion criteria
    1. Prior treatment with serlopitant or other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, orvepitant)
    2. Current smoker or individuals who have given up smoking within the past 12 months
    3. FEV1/FVC < 60%
    4. Body mass index (BMI) < 18 kg/m2 or ≥ 40 kg/m2 at Screening
    5. History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0)
    6. History of cystic fibrosis
    7. History of opioid use (for chronic cough) within 1 week of the Baseline Visit (Day 0)
    8. Requiring concomitant therapy with prohibited medications
    9. Treatment with biologic therapies within 8 weeks or 5 half-lives prior to the Baseline Visit (Day 0), whichever is longer
    10. Treatment with strong CYP3A4 inhibitors within 4 weeks prior to the Baseline Visit (Day 0)
    11. Treatment with any investigational therapy within 4 weeks (investigational biologic therapies within 8 weeks) prior to the Baseline Visit (Day 0)
    12. Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x the upper limit of normal (ULN) during screening
    13. Positive test for any drug of abuse (certain drugs of abuse are acceptable for non-cough indications)
    14. History of malignancy within 5 years prior to the Baseline Visit (Day 0), with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin
    15. Any known psychiatric diagnosis meeting DSM-5 criteria which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject’s ability to comply with protocol-mandated activities, within 3 years prior to randomization. Examples of such DSM-5 diagnoses include but are not limited to major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder
    16. Known active hepatitis infection
    17. Known history of human immunodeficiency virus (HIV) infection
    18. History of hypersensitivity to serlopitant or any of its components
    19. Currently pregnant or breastfeeding female subject
    20. Females of childbearing potential who are unable or unwilling to practice highly effective contraception (pregnancy prevention)
    21. Presence of any medical condition or disability that, in the investigator’s or Menlo Therapeutics Medical Monitor’s opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject, including clinically significant ECG abnormalities during screening
    22. Planned or anticipated major surgical procedure or other activity that would interfere with the subject’s ability to comply with protocol-mandated assessments (e.g., extended international travel) during the subject’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The change from Baseline in 24-hour Cough Frequency after 12 weeks (Day 84) of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 weeks (Day 84) of treatment.
    E.5.2Secondary end point(s)
    1.) Change from Baseline in awake objective cough frequency after 12 weeks (Day 84) of treatment
    2.) Proportion of subjects with ≥ 30% reduction in 24-hour objective cough frequency per hour at Week 12 (Day 84)
    3.) Proportion of subjects with ≥30% reduction in awake objective cough frequency per hour at Week 12 (Day 84)
    4.) Change from Baseline in Cough Severity Visual Analog Scale (VAS) at Week 12 (Day 84)
    5.) Change from Baseline in 24-hour objective cough frequency after 4 and 8 weeks (Days 28 and 56) of treatment
    6.) Change from Baseline in awake objective cough frequency after 4 and 8 weeks (Days 28 and 56) of treatment
    7.) Change from Baseline and change from Day 84 in 24-hour objective cough frequency at the Follow-Up visit (Day 112)
    8.) Change from Baseline in sleep objective cough frequency after 4, 8 and 12 weeks (Days 28, 56 and 84) of treatment
    9.) Change from Baseline in Cough Severity Visual Analog Scale (VAS) at Weeks 4 and 8 (Days 28 and 56)
    10.) Change from Baseline in Leicester Cough Questionnaire (LCQ) individual Domain and Total scores
    11.) Patient's Global Impression of Change (PGIC)
    12.) Clinician's Global Impression of Change (CGIC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.) Awake objective cough frequency after Day 84 treatment
    2.) Subjects ≥ 30% reduction in 24-hour objective cough frequency per hour- Day 84
    3.) Subjects ≥30% reduction in awake objective cough frequency per hour- Day 84
    4.) Cough Severity Visual Analog Scale- Day 84
    5.) 24-hour objective cough frequency after Days 28 and 56 treatment
    6.) Awake objective cough frequency after Days 28 and 56 treatment
    7.) 24-hour objective cough frequency- Day 112
    8.) Sleep objective cough frequency- Day 28, 56 and 84 treatment
    9.) Cough Severity Visual Analog Scale- Day 28 and 56
    10.) Leicester Cough Questionnaire individual Domain and Total scores- Day 0, 28, 56, 85, 113
    11.) Patient's Global Impression of Change- Day 28, 56, 85
    12.) Clinician's Global Impression of Change- Day 85
    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 Yes
    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.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 No
    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
    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 years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 170
    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)
    At the end of the study, treatment of subjects with refractory chronic cough will be left to the discretion of their treating physicians based on standard of care guidelines applicable in the UK.
    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 Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-06
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 03:26:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA