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Alcohol-induced Brain InjuryPhase 2NCT03968042

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

A Phase 2 study testing Nerve Growth Factor, Edaravone and Combination of vitamin B1, B6, C, E and mecobalamine in people with Alcohol-induced Brain Injury, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol-induced Brain Injury
What is being tested?
Nerve Growth Factor, Edaravone and Combination of vitamin B1, B6, C, E and mecobalamine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteChina
Study dates
30 Jun 2019to Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Ying Peng, MD, PhD contact

+86-13380051581

pengy2@mail.sysu.edu.cn

Hongxuan Wang, MD, PhD contact

+86-13824498978

wanghx8@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Recruiting

Other trials in China

About this study

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.

Being tested
Nerve Growth Factor, Edaravone, Combination of vitamin B1, B6, C, E and mecobalamine
Keywords
Alcohol-induced brain injury, atrophy, demyelination
Medical subject headings
Atrophy, Demyelinating Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nerve Growth FactorDrug

    Intramuscular injection for 2 weeks

  • EdaravoneDrug

    Intravenous injection for 2 weeks

  • Combination of vitamin B1, B6, C, E and mecobalamineDrug

    Medications of combination of vitamin B1, B6, C, E and mecobalamine for 6 months

Study groups in NCT03968042
Study groupRoleWhat they receive
Regular treatment (RT)Placebo comparatorCombination of vitamin B1, B6, C, E and mecobalamine
Receives: Drug: Combination of vitamin B1, B6, C, E and mecobalamine
RT with NGFExperimentalNerve growth factor adding to regular treatment
Receives: Drug: Nerve Growth Factor; Drug: Combination of vitamin B1, B6, C, E and mecobalamine
RT with EDVExperimentalEdaravone adding to regular treatment
Receives: Drug: Edaravone; Drug: Combination of vitamin B1, B6, C, E and mecobalamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive improvement

    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.

    Measured: 2 weeks

  2. Cognitive improvement

    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.

    Measured: 2 months

  3. Cognitive improvement

    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.

    Measured: 3 months

  4. Cognitive improvement

    Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.

    Measured: 6 months

  5. Cognitive assessment

    Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.

    Measured: 3 months

  6. Cognitive assessment

    Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.

    Measured: 6 months

Secondary outcomes (7)

  1. The rate of relapse of alcohol dependence after discharge from hospital

    Recurrence of alcohol dependence

    Measured: 2 months

  2. Duration of abstinence

    The total time or period without any intake of alcohol during follow ups

    Measured: 6 months

  3. Alcohol intake

    Diaries of alcohol intake in different time of the follow ups

    Measured: 2 weeks, 2 months, 3 months, 6 months

  4. Craving for alcohol

    Craving assessment for alcohol by Obsessive Compulsive Drinking Scale (OCDS) ranging from 0 to 40. Higher score of OCDS indicates more desire for alcohol.

    Measured: 2 weeks, 2 months, 3 months, 6 months

  5. Psychological assessment - Anxiety

    Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.

    Measured: 2 weeks, 2 months, 3 months, 6 months

  6. Psychological assessment - Depression

    Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.

    Measured: 2 weeks, 2 months, 3 months, 6 months

  7. Psychological assessment - Sleep

    Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.

    Measured: 2 weeks, 2 months, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2019
  2. Study start30 Jun 2019
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03968042
Sponsor's protocol ID
2019-13-NGF-EDV
Status last verified
Oct 2020
First submitted
28 May 2019
Last updated
27 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26060244

  • 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.

    PubMed 24135530

  • 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.

    PubMed 19240603

  • 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.

    PubMed 28522181

  • 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. doi: 10.1212/wnl.51.3.695.

    PubMed 9748012

  • Riggs JE. Recombinant human nerve growth factor in the treatment of diabetic polyneuropathy. Neurology. 1999 Apr 22;52(7):1517-8. doi: 10.1212/wnl.52.7.1517-a. No abstract available.

    PubMed 10227655

  • 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. doi: 10.1212/wnl.54.5.1080.

    PubMed 10720278

  • 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. doi: 10.1056/NEJM199804233381702.

    PubMed 9554857

  • 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. doi: 10.1002/ana.410360221.

    PubMed 8053664

  • 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. doi: 10.1016/s0254-6272(09)60029-7.

    PubMed 19514187

  • 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.

    PubMed 18457257

  • Wang H, Liu L, Zhou X, Guan Y, Li Y, Chen P, Duan R, Yang W, Rong X, Wu C, Yang J, Yang M, Jia Y, Hu J, Zhu X, Peng Y. Efficacy and safety of short-term edaravone or nerve growth factor add-on therapy for alcohol-related brain damage: A multi-centre randomised control trial. Addiction. 2024 Apr;119(4):717-729. doi: 10.1111/add.16398. Epub 2023 Dec 4.

    PubMed 38049955

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nerve Growth Factor, Edaravone and Combination of vitamin B1, B6, C, E and mecobalamine in people with Alcohol-induced Brain Injury, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ying Peng, MD, PhD (+86-13380051581, pengy2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive improvement (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03968042, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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