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Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury
NCT03968042Phase 2
Key facts
- Status
- Unknown
- Start
- Jun 2019
- Primary completion
- Dec 2021
- Countries
- 1
- Sponsor
- Sun Yat-sen Memorial Hospital
- Modality
- Recombinant Proteins and Enzymes, Small Molecules
- Conditions
- Brain Injury (BI)
01
Overview
Phase 2, randomised trial of Nerve growth factor and edaravone in Brain Injury (BI) (3 arms), sponsored by Sun Yat-sen Memorial Hospital. Primary endpoints: Cognitive improvement at 6 months and Cognitive assessment at 6 months. Status: unknown.
02
Design
3 arms- Study design
- Randomized
Regular treatment (RT)
Combination of vitamin B1, B6, C, E and mecobalamine for 6 months
RT with NGF
Nerve growth factor for 2 weeks + RT for 6 months
RT with EDV
Edaravone for 2 weeks + RT for 6 months
03
Who it enrols
Patients with alcohol dependence and MRI-proved demyelinating lesions or atrophy, excluding those with acute withdrawal, other neurological/psychological problems, or other substance dependence.
04
Endpoints
Primary
Cognitive improvement
Cognitive assessment
Secondary
Rate of relapse of alcohol dependence
Duration of abstinence
Alcohol intake
Craving for alcohol
Psychological assessment - Anxiety
Psychological assessment - Depression
Psychological assessment - Sleep
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