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    EudraCT Number:2016-003107-65
    Sponsor's Protocol Code Number:OPNT001-BN-001
    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:2016-11-29
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-003107-65
    A.3Full title of the trial
    Randomised, double-blind, placebo controlled trial evaluating the effects of naloxone hydrochloride nasal spray on eating behaviours in bulimia nervosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised, double-blind, placebo controlled trial evaluating the effects of naloxone hydrochloride nasal spray on eating behaviours in bulimia nervosa
    A.3.2Name or abbreviated title of the trial where available
    Effects of intranasal naloxone on eating behaviours in bulimia nervosa
    A.4.1Sponsor's protocol code numberOPNT001-BN-001
    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 SponsorOpiant Pharmaceuticals 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 supportOpiant Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOpiant Pharmaceuticals UK Ltd
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address83 Baker Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1U 6AG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02037661188
    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 nameNaloxone hydrochloride 40mg/ml nasal spray
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnaloxone hydrochloride
    D.3.9.1CAS number 51481-60-8
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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. 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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bulimia nervosa
    E.1.1.1Medical condition in easily understood language
    An emotional disorder in which bouts of over eating are followed by fasting or self-induced vomiting or purging
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006550
    E.1.2Term Bulimia nervosa
    E.1.2System Organ Class 10037175 - Psychiatric 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 if treatment with naloxone hydrochloride nasal spray reduces the binging behaviour in bulimia nervosa.
    E.2.2Secondary objectives of the trial
    To assess the effects of naloxone hydrochloride nasal spray on immediate eating behaviours.
    To assess the effects of naloxone hydrochloride nasal spray on eating behaviours.
    To assess the difference in the effects of naloxone hydrochloride nasal spray between a single dose compared to multiple doses.
    To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of bulimia nervosa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female aged 18 to 60 years, fluent in English, having provided written, informed consent prior to any study specific procedure being conducted
    2. Diagnosis of bulimia nervosa according to Diagnostic and Statistical Manual of Mental Illness’s (5th Edition) criteria by The Structured Clinical Interview for the DSM-5- Research Version (SCID-RV) prior to screening
    3. Subjects reporting at least one binging day per week during screening
    E.4Principal exclusion criteria
    1. Severe comorbidity (e.g., substance abuse, drug addiction, psychosis, diabetes)
    2. Previous (in the last 12 months) or current opioid, alcohol, or other drug dependence (excluding nicotine and caffeine), based on medical history prior to screening
    3. Any history of neurological condition considered by the investigator to be clinically significant in the context of the study
    4. Known allergic reaction to naloxone
    5. Known allergic reaction to excipients of IMP and placebo
    6. Subject is taking any prohibited medication (opioid analgesics, any medication delivered to the nose)
    7. Opioids (unless discontinued at least 4 weeks prior to screening)
    8. Any fluoxetine treatment (unless it has been administered at a stable dose for a minimum of 12 weeks prior to screening and remain at a stable dose throughout the trial)
    9. Any cognitive behavioural therapy (CBT) or other behavioural therapies (unless it has been completed or has currently been receiving CBT or other behavioural therapies for more than 8 weeks prior to screening. No new CBT or other behavioural therapies started during the trial)
    10. Experimental agents must have been discontinued at least 8 weeks prior to screening or a period equivalent to 5 half-lives of the agent (whichever is longer)
    11. A significant visual impairment, which is not corrected by eyewear
    12. Any nasal conditions including abnormal nasal anatomy, nasal symptoms (i.e. blocked and/or runny nose, nasal polyps etc.), or having product sprayed in to the nasal cavity prior to drug administration
    13. Consume more than 21 units of alcohol per week (1 unit = 1/2 pint of beer (285mls) or 25ml of spirits or 1 glass of wine) (in the past 6 months prior to screening)
    14. Positive urine drug test for opioids at screening or baseline
    15. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile must use effective contraception (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 [IUD], intrauterine hormone-releasing system [IUS], vasectomised partner, sexual abstinence, combination of male condom with either cap, diaphragm or sponge with spermicide [double barrier methods]), and willing and able to continue contraception for 1 month after the last administration of IMP. Women using oral contraception must have started using it at least 2 months prior to screening. Women are not considered to be of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels that have been confirmed to be in the “postmenopausal range”. Or have had a surgical bilateral oophorectomy (with or without hysterectomy) or bilateral tubal ligation at least six weeks before the screening visit. In case of oophorectomy alone, the reproductive status of the woman should have been confirmed by follow up hormone level assessment.
    16. Women who are pregnant or breastfeeding at screening or baseline
    17. Subject with concurrent disease considered by the investigator to be clinically significant in the context of the study
    18. Active, uncontrolled severe mental illness (e.g. psychosis, bipolar disorder, schizoaffective disorder) and/or a history or evidence of organic brain disease or dementia that would compromise the participant’s ability to comply with the study protocol
    19. Subject is deemed unlikely to be able to comply with the requirements of the protocol
    20. Subjects with any laboratory tests from samples taken at screening considered clinically significant
    E.5 End points
    E.5.1Primary end point(s)
    Number of binging days from baseline to Week 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    • Number of binging episodes from baseline to Week 8
    • Abstinence of binging at Week 8 for at least a two week period
    • Purging behaviour at Week 8
    • Total number of calories in the taste test at Week 8
    • Total number of calories in the taste test at baseline
    • EDE-Q Week 8
    • VAS (on mood, craving, hunger, anxiety, purging and feeling full) at Week 8
    • FCQ at Week 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Number of binging episodes - Week 8
    • Abstinence of binging at Week 8 for at least a two week period
    • Purging behaviour - Week 8
    • Total number of calories in the taste test - Week 8
    • Total number of calories in the taste test - baseline
    • EDE-Q - Week 8
    • VAS (on mood, craving, hunger, anxiety, purging and feeling full)- Week 8
    • FCQ - Week 8
    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. 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 concerned8
    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 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
    The end of the trial is the last patient follow-up call (14 days after the last patient Week 8 visit)
    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 months2
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 82
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state82
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 82
    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)
    The study drug will be made available free of charge if it offers benefit under a managed access program after the study has been completed.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-02
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