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出境医 / 临床实验 / Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Alcohol-induced Brain Injury Drug: Nerve Growth Factor Drug: Edaravone Drug: Combination of vitamin B1, B6, C, E and mecobalamine Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Regular treatment (RT)
Combination of vitamin B1, B6, C, E and mecobalamine
 Drug: Combination of vitamin B1, B6, C, E and mecobalamine
Medications of combination of vitamin B1, B6, C, E and mecobalamine for 6 months
Experimental: RT with NGF
Nerve growth factor adding to regular treatment
 Drug: Nerve Growth Factor
Intramuscular 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
Experimental: RT with EDV
Edaravone adding to regular treatment
 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
Outcome Measures
Primary Outcome Measures :
  1. Cognitive improvement [ Time Frame: 2 weeks ]
    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.

  2. Cognitive improvement [ Time Frame: 2 months ]
    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.

  3. Cognitive improvement [ Time Frame: 3 months ]
    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.

  4. Cognitive improvement [ Time Frame: 6 months ]
    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.

  5. Cognitive assessment [ Time Frame: 3 months ]
    Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.

  6. Cognitive assessment [ Time Frame: 6 months ]
    Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.


Secondary Outcome Measures :
  1. The rate of relapse of alcohol dependence after discharge from hospital [ Time Frame: 2 months ]
    Recurrence of alcohol dependence

  2. Duration of abstinence [ Time Frame: 6 months ]
    The total time or period without any intake of alcohol during follow ups

  3. Alcohol intake [ Time Frame: 2 weeks, 2 months, 3 months, 6 months ]
    Diaries of alcohol intake in different time of the follow ups

  4. Craving for alcohol [ Time Frame: 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.

  5. Psychological assessment - Anxiety [ Time Frame: 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.

  6. Psychological assessment - Depression [ Time Frame: 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.

  7. Psychological assessment - Sleep [ Time Frame: 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ying Peng, MD, PhD +86-13380051581 pengy2@mail.sysu.edu.cn
Contact: Hongxuan Wang, MD, PhD +86-13824498978 wanghx8@mail.sysu.edu.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE June 30, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Cognitive improvement [ Time Frame: 2 weeks ]
    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
  • Cognitive improvement [ Time Frame: 2 months ]
    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
  • Cognitive improvement [ Time Frame: 3 months ]
    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
  • Cognitive improvement [ Time Frame: 6 months ]
    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
  • Cognitive assessment [ Time Frame: 3 months ]
    Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
  • Cognitive assessment [ Time Frame: 6 months ]
    Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • The rate of relapse of alcohol dependence after discharge from hospital [ Time Frame: 2 months ]
    Recurrence of alcohol dependence
  • Duration of abstinence [ Time Frame: 6 months ]
    The total time or period without any intake of alcohol during follow ups
  • Alcohol intake [ Time Frame: 2 weeks, 2 months, 3 months, 6 months ]
    Diaries of alcohol intake in different time of the follow ups
  • Craving for alcohol [ Time Frame: 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 - Anxiety [ Time Frame: 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 - Depression [ Time Frame: 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.
  • Psychological assessment - Sleep [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury
Official Title  ICMJE Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol-induced Brain Injury
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Regular treatment (RT)
    Combination of vitamin B1, B6, C, E and mecobalamine
    Intervention: Drug: Combination of vitamin B1, B6, C, E and mecobalamine
  • Experimental: RT with NGF
    Nerve growth factor adding to regular treatment
    Interventions:
    • Drug: Nerve Growth Factor
    • Drug: Combination of vitamin B1, B6, C, E and mecobalamine
  • Experimental: RT with EDV
    Edaravone adding to regular treatment
    Interventions:
    • Drug: Edaravone
    • Drug: Combination of vitamin B1, B6, C, E and mecobalamine
Publications *
  • Sun YY, Li Y, Wali B, Li Y, Lee J, Heinmiller A, Abe K, Stein DG, Mao H, Sayeed I, Kuan CY. Prophylactic Edaravone Prevents Transient Hypoxic-Ischemic Brain Injury: Implications for Perioperative Neuroprotection. Stroke. 2015 Jul;46(7):1947-55. doi: 10.1161/STROKEAHA.115.009162. Epub 2015 Jun 9.
  • Kaste M, Murayama S, Ford GA, Dippel DW, Walters MR, Tatlisumak T; MCI-186 study group. Safety, tolerability and pharmacokinetics of MCI-186 in patients with acute ischemic stroke: new formulation and dosing regimen. Cerebrovasc Dis. 2013;36(3):196-204. doi: 10.1159/000353680. Epub 2013 Oct 12. Erratum in: Cerebrovasc Dis. 2013;36(5-6):461.
  • Munakata A, Ohkuma H, Nakano T, Shimamura N, Asano K, Naraoka M. Effect of a free radical scavenger, edaravone, in the treatment of patients with aneurysmal subarachnoid hemorrhage. Neurosurgery. 2009 Mar;64(3):423-8; discussion 428-9. doi: 10.1227/01.NEU.0000338067.83059.EB.
  • Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/S1474-4422(17)30115-1. Epub 2017 May 15.
  • Apfel SC, Kessler JA, Adornato BT, Litchy WJ, Sanders C, Rask CA. Recombinant human nerve growth factor in the treatment of diabetic polyneuropathy. NGF Study Group. Neurology. 1998 Sep;51(3):695-702.
  • Riggs JE. Recombinant human nerve growth factor in the treatment of diabetic polyneuropathy. Neurology. 1999 Apr 22;52(7):1517-8.
  • McArthur JC, Yiannoutsos C, Simpson DM, Adornato BT, Singer EJ, Hollander H, Marra C, Rubin M, Cohen BA, Tucker T, Navia BA, Schifitto G, Katzenstein D, Rask C, Zaborski L, Smith ME, Shriver S, Millar L, Clifford DB, Karalnik IJ. A phase II trial of nerve growth factor for sensory neuropathy associated with HIV infection. AIDS Clinical Trials Group Team 291. Neurology. 2000 Mar 14;54(5):1080-8. Erratum in: Neurology 2000 Jul 13;55(1):162.
  • Lambiase A, Rama P, Bonini S, Caprioglio G, Aloe L. Topical treatment with nerve growth factor for corneal neurotrophic ulcers. N Engl J Med. 1998 Apr 23;338(17):1174-80.
  • Petty BG, Cornblath DR, Adornato BT, Chaudhry V, Flexner C, Wachsman M, Sinicropi D, Burton LE, Peroutka SJ. The effect of systemically administered recombinant human nerve growth factor in healthy human subjects. Ann Neurol. 1994 Aug;36(2):244-6.
  • Zhou F, Wu P, Wang L, Wang HT, Zhang SB, Lin Y, Zhong H, Chen YH. The NGF point-injection for treatment of the sound-perceiving nerve deafness and tinnitus in 68 cases. J Tradit Chin Med. 2009 Mar;29(1):39-42.
  • Wu ZH, Huang J, Gao WH, Wang AL, Jia Q, Chen B, Xu S, Gu YH. [Effect of nerve growth factor on the promotion of sensory recovery of large skin graft in patients]. Zhonghua Shao Shang Za Zhi. 2007 Dec;23(6):440-3. Chinese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ying Peng, MD, PhD +86-13380051581 pengy2@mail.sysu.edu.cn
Contact: Hongxuan Wang, MD, PhD +86-13824498978 wanghx8@mail.sysu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03968042
Other Study ID Numbers  ICMJE 2019-13-NGF-EDV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ying Peng, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Sponsor  ICMJE Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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