E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
An emotional disorder in which bouts of over eating are followed by fasting or self-induced vomiting or purging |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006550 |
E.1.2 | Term | Bulimia nervosa |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess if treatment with naloxone hydrochloride nasal spray reduces the binging behaviour in bulimia nervosa. |
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E.2.2 | Secondary 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of binging days from baseline to Week 8. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary 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
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E.5.2.1 | Timepoint(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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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The end of the trial is the last patient follow-up call (14 days after the last patient Week 8 visit) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 31 |