NCT03968042

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol-induced Brain Injury

Interventions

Type	Name	Description
DRUG	Nerve Growth Factor	Intramuscular injection for 2 weeks
DRUG	Edaravone	Intravenous injection for 2 weeks
DRUG	Combination of vitamin B1, B6, C, E and mecobalamine	Medications of combination of vitamin B1, B6, C, E and mecobalamine for 6 months

Timeline

• Start date: 2019-06-30
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-05-30
• Last updated: 2020-10-27

Locations

1 site across 1 country: China