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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Alcohol-induced Brain Injury

Treatments: Drug: Nerve Growth Factor; Drug: Edaravone; Drug: Combination of vitamin B1, B6, C, E and mecobalamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03968042

2019-13-NGF-EDV

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Regular treatment (RT)

Placebo Comparator group

Description:

Combination of vitamin B1, B6, C, E and mecobalamine

Treatment:

Drug: Combination of vitamin B1, B6, C, E and mecobalamine

RT with NGF

Experimental group

Description:

Nerve growth factor adding to regular treatment

Treatment:

Drug: Nerve Growth Factor

Drug: Combination of vitamin B1, B6, C, E and mecobalamine

RT with EDV

Experimental group

Description:

Edaravone adding to regular treatment

Treatment:

Drug: Edaravone

Drug: Combination of vitamin B1, B6, C, E and mecobalamine