E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001639 |
E.1.2 | Term | Alcoholism |
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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 the effects of Org 25935 on heavy drinking in subjects with alcohol dependence. |
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E.2.2 | Secondary objectives of the trial |
• To assess the effects of Org 25935 on the amount of drinking • To assess the effects of Org 25935 on the first relapse to heavy drinking • To assess the effects of Org 25935 on abstinence • To assess the safety and tolerability of Org 25935 • To explore potential predictors of response to Org 25935 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provide written informed consent after the scope and nature of the investigation, have been explained to the subject before screening; 2. Diagnosis of alcohol dependence - meeting at least 5 out of 7 criteria according to DSM-IV-TR specifier; one of which should be criterion 1 (tolerance) or 2 (withdrawal); 3. Primary complaints according to Mini-International Neuropsychiatric Interview (MINI) should be alcohol problems; 4. Subjects must have gone through a detoxification program, have a clearly stated desire to stay abstinent and present at baseline with the following: be alcohol abstinent for at least 3 days, benzodiazepine free for at least 3 days, and a Clinical Institute Withdrawal Assessment (CIWA) score < 10; 5. Age 18-65 years at screening; 6. Males, or females who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or who are non-pregnant, non-lactating and using a medically accepted method of contraception; these include condoms with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, and hormonal contraceptives; 7. BMI > 16 kg/m2; 8. Breath alcohol concentration < 0.02% (at screening and at baseline). |
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E.4 | Principal exclusion criteria |
9. Subjects requiring pharmacological treatment for a primary diagnosis of major depressive disorder, anxiety, panic disorder or social phobia; 10. Subjects with psychotic disorders (according to MINI); 11. Subjects with a medium or high suicidality risk (as assessed by MINI); 12. Active substance abuse (resulting in either physical or mental damage as defined by ICD10) or dependence other than alcohol (excluding nicotine) within 12 months prior to screening, e.g. cannabis, benzodiazepine, amphetamines, chlo(r)methiazole, opiates, cocaine, hallucinogens or other substances; 13. Use of one of the following drugs during the last 14 days prior to screening: cannabis, amphetamines, opiates, cocaine, hallucinogens; 14. Use of any medication that can have an effect on alcohol consumption within 30 days of study initiation, including naltrexone, acamprosate, disulfiram, ondansetron, topiramate, SSRIs, mirtazapine, varencicline, gabapentin, levetiracetam; 15. A clinically relevant visual disturbance, such as cataract, color blindness, macular degeneration, glaucoma or retinal disease; 16. Untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, hematological, immunological or cerebrovascular disease, malignancy, or other chronic and/or degenerative process at screening; 17. Any clinically meaningful abnormal laboratory, vital sign, physical examination or ECG finding which, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations; 18. QTc interval (Fridericia corrected) at screening >450 ms (male), >470 ms (female); 19. Serious neuropsychiatric condition that can impair judgment or cognitive function (including dementia or amnestic disorder) to an extent that providing informed consent or complying with treatment is precluded; 20. History or present evidence of epileptic disorders or withdrawal seizures; 21. History of substance withdrawal delirium; 22. Breast-feeding woman, or a positive result of urine pregnancy test (at screening), or plan to become pregnant during the course of the trial (females only); 23. Pending legal charges with the potential for incarceration, probation, or parole; 24. Homelessness (less than 2 months stable residence); 25. Participation in a clinical trial during the three months prior to screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of heavy drinking days, defined as days with ≥ 5 standard drinks for men and ≥ 4 standard drinks for women (assessed by timeline follow back method (TLFB)) |
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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.8.3 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial 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
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 3 |