title: Safety and efficacy of intravenous ultra-high dose methylcobalamin treatment for peripheral neuropathy: a phase I/II open label clinical trial.
abstract: OBJECTIVE
  No clinically effective treatment for promoting peripheral axonal regeneration has yet been established. Several experimental studies in vitro and in vivo have shown that a high dose of methylcobalamin (MeCbl), an analogue of vitamin B12, promotes axonal growth in peripheral nerve injury. We herein assessed the safety and efficacy of an ultra-high dose MeCbl treatment for patients with peripheral neuropathy and chronic axonal degeneration.
  
  
  METHODS
  Fourteen patients with immune-mediated or hereditary neuropathy in the chronic progressive or stable phase were enrolled. MeCbl, 25 mg/day for 10 days followed by monthly 25 mg for 5 months, was intravenously administered. The patients were evaluated before and 1 year following treatment. The primary endpoints were safety and improvement in the Medical Research Council (MRC) sum score in at least two muscles of the 20 muscles. This trial is registered with the University Hospital Medical Information Network (UMIN) Center in Japan under the ID: UMIN000009359.
  
  
  RESULTS
  There were no adverse effects in twelve of the patients, whereas treatment was discontinued in two patients who had seborrheic dermatitis at 3 months and respiratory tract infection at 2 months, respectively. Therefore, twelve patients were evaluated for the primary outcomes; the MRC sum score was improved in seven of the patients and unchanged or worsened in the remaining five patients.
  
  
  CONCLUSIONS
  Intravenous ultra-high dose MeCbl treatment is a safe and potentially efficacious therapy for patients with peripheral neuropathy and chronic axonal degeneration.
authors.affiliation: Department of Neurology, Graduate School of Medicine, Chiba University, Japan.
authors.forename: Kazumoto
authors.initials: K
authors.lastname: Shibuya
authors.forename: Sonoko
authors.initials: S
authors.lastname: Misawa
authors.forename: Saiko
authors.initials: S
authors.lastname: Nasu
authors.forename: Yukari
authors.initials: Y
authors.lastname: Sekiguchi
authors.forename: Minako
authors.initials: M
authors.lastname: Beppu
authors.forename: Yuta
authors.initials: Y
authors.lastname: Iwai
authors.forename: Satsuki
authors.initials: S
authors.lastname: Mitsuma
authors.forename: Sagiri
authors.initials: S
authors.lastname: Isose
authors.forename: Kimiyoshi
authors.initials: K
authors.lastname: Arimura
authors.forename: Ryuji
authors.initials: R
authors.lastname: Kaji
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kuwabara
mesh_terms: D000328:Adult; D000368:Aged; D001369:Axons / Q000187:drug effects / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000294:innervation; D009416:Nerve Regeneration / Q000187:drug effects*; D010523:Peripheral Nervous System Diseases / Q000188:drug therapy* / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome; D014805:Vitamin B 12 / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: C019476:mecobalamin; D014805:Vitamin B 12