Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury
NCT ID: NCT03968042
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2019-06-30
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Regular treatment (RT)
Combination of vitamin B1, B6, C, E and mecobalamine
Combination of vitamin B1, B6, C, E and mecobalamine
Medications of combination of vitamin B1, B6, C, E and mecobalamine for 6 months
RT with NGF
Nerve growth factor adding to regular treatment
Nerve Growth Factor
Intramuscular injection for 2 weeks
Combination of vitamin B1, B6, C, E and mecobalamine
Medications of combination of vitamin B1, B6, C, E and mecobalamine for 6 months
RT with EDV
Edaravone adding to regular treatment
Edaravone
Intravenous injection for 2 weeks
Combination of vitamin B1, B6, C, E and mecobalamine
Medications of combination of vitamin B1, B6, C, E and mecobalamine for 6 months
Interventions
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Nerve Growth Factor
Intramuscular injection for 2 weeks
Edaravone
Intravenous injection for 2 weeks
Combination of vitamin B1, B6, C, E and mecobalamine
Medications of combination of vitamin B1, B6, C, E and mecobalamine for 6 months
Eligibility Criteria
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Inclusion 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
* With other neurological diseases and psychological problems
* With ever brain trauma and damage
* With other psychological medications or other substance dependence
18 Years
65 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Ying Peng
Professor, Director of Department of Neurology
Locations
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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References
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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.
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. doi: 10.1212/wnl.51.3.695.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2019-13-NGF-EDV
Identifier Type: -
Identifier Source: org_study_id