Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury

Phase 2

• Conditions: Alcohol-induced Brain Injury
• Interventions: Drug: Edaravone; Drug: Nerve Growth Factor; Drug: Combination of vitamin B1, B6, C, E and mecobalamine

• Registration Number: NCT03968042
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

Alcohol is one of most common harmful substance, and alcohol intake brings great burden on health worldwide. Excess alcohol intake may lead to alcohol-related brain injuries and cognitive impairment. Although both nerve growth factor and antioxidative treatment were effective to relieve alcohol-related injuries in central nervous system in the preclinical studies, there is no relevant clinical trial about their efficacy and safety on patients. Since nerve growth factor and one of the antioxidative medication, edaravone, have been used in some neural diseases in clinical trials, we tend to evaluate the efficacy and safety of nerve growth factor, or edaravone on alcohol-induced brain injuries. The study is a randomized-controlled study and the patients will be assigned into one of the following three groups randomly: (1) regular treatment (combination of vitamin B1, B6, C, E and mecobalamine) with nerve growth factor for 2 weeks and subsequently regular treatment for 6 months; (2) regular treatment (RT) with edaravone for 2 weeks and subsequently RT for 6 months; (3) RT alone for 6 months. The patients will be followed up for 6 months. Cognitive functions, recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other psychological assessments will be recorded and compared among the 3 treatment groups and the efficacy of nerve growth factor or edaravone will be evaluated in our study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-30
• Study Start: 2019-06-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-24
• Last Update Posted: 2020-10-27
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Diagnosis as alcohol dependence according to DSM-IV criteria
• MRI-proved demyelinating lesions or atrophy in the brain of the patient
• No definite history of neurological diseases and psychological problems
• Volunteer to participate the study, cooperate to be followed up

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Exclusion Criteria

• Acute withdrawal state and CIWA score > 9
• With other neurological diseases and psychological problems
• With ever brain trauma and damage
• With other psychological medications or other substance dependence

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RT with NGF	Combination of vitamin B1, B6, C, E and mecobalamine	Nerve growth factor adding to regular treatment
RT with EDV	Combination of vitamin B1, B6, C, E and mecobalamine	Edaravone adding to regular treatment
Regular treatment (RT)	Combination of vitamin B1, B6, C, E and mecobalamine	Combination of vitamin B1, B6, C, E and mecobalamine
RT with EDV	Edaravone	Edaravone adding to regular treatment
RT with NGF	Nerve Growth Factor	Nerve growth factor adding to regular treatment

Primary Outcome Measures

Name	Time	Method
Cognitive improvement	6 months	Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
Cognitive assessment	6 months	Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.

Secondary Outcome Measures

Name	Time	Method
Craving for alcohol	2 weeks, 2 months, 3 months, 6 months	Craving assessment for alcohol by Obsessive Compulsive Drinking Scale (OCDS) ranging from 0 to 40. Higher score of OCDS indicates more desire for alcohol.
Psychological assessment - Depression	2 weeks, 2 months, 3 months, 6 months	Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.
The rate of relapse of alcohol dependence after discharge from hospital	2 months	Recurrence of alcohol dependence
Duration of abstinence	6 months	The total time or period without any intake of alcohol during follow ups
Alcohol intake	2 weeks, 2 months, 3 months, 6 months	Diaries of alcohol intake in different time of the follow ups
Psychological assessment - Anxiety	2 weeks, 2 months, 3 months, 6 months	Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.
Psychological assessment - Sleep	2 weeks, 2 months, 3 months, 6 months	Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China