Efficacy and safety of Sodium Oxybate in reducing alcohol consumption and maintaining abstinence in alcohol-dependent subjects with high and very high drinking risk level

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratorio Farmaceutico C.T. S.r.l.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

13 Jul 2021 → ongoing

Decision date (initial)

2024-08-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-506990-37-00

EudraCT number

2019-001834-33

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective of the present study is to demonstrate the efficacy of Sodium Oxibate in reducing the alcohol consumption of alcohol-dependent Subjects with HDRL and VHDRL, as measured by the number of HDDs.

Conditions and MedDRA coding

Alcohol addiction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. The study population will be enrolled among alcohol-dependent Subjects afferent to the centers. Alcohol-dependent Subjects regular drinkers of alcoholic beverages, with HDRL and VHDRL of alcohol consumption, naïve for Alcover treatment high-risk alcohol consumption will be considered for the enrolment in the present study. All the below inclusion criteria must be fulfilled at Visit 1, by each Subject to be included in the trial: 1. Signature of Informed Consent for the study and for treatment of personal data 2. Male or female of any ethnic group between 18- and 70 -years old 3. Body weight between 60 and 100 kg with a BMI＜ 40 4. Current diagnosis of alcohol use disorder according to the DSM-5 5. High or very high DRL of alcohol consumption based on WHO criteria (HDRL:> 60 g / day in males and> 40 g / day in females; VHDRL:> 100 g / day in males and> 60 g / day in females) 6. No or mild alcohol withdrawal symptoms, defined as CIWA-Ar score < 10 7. Medical conditions compatible with the safe enrollment as confirmed by medical history and physical examination 8. At least 4 HDDs per week in the 4 weeks prior to the screening visit 9. Ability/possibility to efficacy fill in the TFLB and study administered scale 10. Ability/possibility to assume the study drug/placebo 11. Subjects with cirrhosis only: compensated medical condition determined based on the clinical evaluation and psychometric assessment as measured using ANT1 (cut-off value >15) 12. Females only: postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry, throughout the study, and for two months after the end of treatment

Exclusion criteria 1

1. A Subject who met at least one of the following conditions is not eligible and should not be addressed to randomization and treatment phase: 1. Use of Sodium Oxybate during the three months prior to randomitation 2. Current diagnosis of substance dependence other than alcohol and nicotine 3. Lifetime diagnosis of schizophrenia, bipolar disorders, or other psychoses; lifetime diagnosis of Major Depression and history of attempted suicide. 4. History of epilepsy or alcohol-related seizures 5. Positive urine test for cocaine, opiates, methadone at any time during the study. 6. Current participation to another study or participation to an interventional study conducted during 3 months prior to randomization. 7. Females only: breast-feeding and/or positive urine pregnancy test at any time during the study. 8. Severe diseases and/or medical conditions, both acute and chronic, which in the opinion of the investigator jeopardize patient safety, including respiratory depression, liver diseases (e.g. acute hepatitis), decompensated cirrhosis. 9. Presence of particular social condition that, at the investigator judgement, may interfere with the proper study conduct (i.e. subject social marginalisation, Homeless condition, known history of previous crimes related to sexual abuse, drug dealing, etc) 10. Patients with porphyria 11. History of current epileptic syndrome with the exception of neonate convulsions. Patients with epileptic episodes due to alcohol withdrawal are also excluded 12. Known medical history of succinic semialdehyde dehydrogenase deficiency 13. Any significant cerebral vascular and/or cardiovascular disease (e.g., unstable angina pectoris at rest or for minimal effort, acute myocardial infarction within the last 3 months, hearth failure NYHA class II-IV) 14. Any neurological or psychiatric disorders resulting in disorientation, memory impairment, inability to report accurately (for instance Alzheimer’s disease and any other dementia) 15. Concomitant use of psychotropic medications including antiepileptic agents that cannot be discontinued; any medication that may have an effect on alcohol consumption, including baclofen, naltrexone, acamprosate, nalmefene, alcohol dehydrogenase inhibitors, topiramate, gabapentin, ondansetron, benzodiazepines, opioid analgesics, dopamine/norephinefrine reuptake inhibitors. 16. Subjects requiring a structured psychotherapy 17. Hypersensitivity to the active substance or to any of the excipients. 18. Female subjects not willing to undergo to an adequate contraception method for the study duration.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary end point of the study is the reduction of HDDs as measured by the average number of HDDs after 3 months of treatment (Visit 7, week 12).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorio Farmaceutico C.T. S.r.l.

Sponsor organisation

Laboratorio Farmaceutico C.T. S.r.l.

Address

Via Dante Alighieri 71

City

Sanremo

Postcode

18038

Country

Italy

Scientific contact point

Organisation

Laboratorio Farmaceutico C.T. S.r.l.

Contact name

Benedetta Porro

Public contact point

Organisation

Laboratorio Farmaceutico C.T. S.r.l.

Contact name

Benedetta Porro

Locations

3 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 59 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications