title: Phase III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis.
abstract: BACKGROUND
  Preclinical and clinical studies of gabapentin in patients with ALS led the authors to undertake a phase III randomized clinical trial.
  
  
  METHODS
  Patients were randomly assigned, in a double-blinded fashion, to receive oral gabapentin 3,600 mg or placebo daily for 9 months. The primary outcome measure was the average rate of decline in isometric arm muscle strength for those with two or more evaluations.
  
  
  RESULTS
  Two hundred four patients enrolled, 196 had two or more evaluations, and 128 patients completed the study. The mean rate of decline of the arm muscle strength was not significantly different between the groups. Moreover, there was no beneficial effect upon the rate of decline of other secondary measures (vital capacity, survival, ALS functional rating scale, timed walking) nor was there any symptomatic benefit. In fact, analysis of the combined data from the phase II and III trials revealed a significantly more rapid decline of forced vital capacity in patients treated with gabapentin.
  
  
  CONCLUSIONS
  These data provide no evidence of a beneficial effect of gabapentin on disease progression or symptoms in patients with ALS.
authors: Department of Neurology, California Pacific Medical Center, San Francisco, USA. rmiller@cooper.cpmc.org
authors: R G
authors: RG
authors: Miller
authors: D H
authors: DH
authors: Moore
authors: D F
authors: DF
authors: Gelinas
authors: V
authors: V
authors: Dronsky
authors: M
authors: M
authors: Mendoza
authors: R J
authors: RJ
authors: Barohn
authors: W
authors: W
authors: Bryan
authors: J
authors: J
authors: Ravits
authors: E
authors: E
authors: Yuen
authors: H
authors: H
authors: Neville
authors: S
authors: S
authors: Ringel
authors: M
authors: M
authors: Bromberg
authors: J
authors: J
authors: Petajan
authors: A A
authors: AA
authors: Amato
authors: C
authors: C
authors: Jackson
authors: W
authors: W
authors: Johnson
authors: R
authors: R
authors: Mandler
authors: P
authors: P
authors: Bosch
authors: B
authors: B
authors: Smith
authors: M
authors: M
authors: Graves
authors: M
authors: M
authors: Ross
authors: E J
authors: EJ
authors: Sorenson
authors: P
authors: P
authors: Kelkar
authors: G
authors: G
authors: Parry
authors: R
authors: R
authors: Olney
mesh_terms: D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects*; D000588:Amines; D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy* / Q000401:mortality; D003509:Cyclohexanecarboxylic Acids; D004311:Double-Blind Method; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D018401:Sample Size; D016019:Survival Analysis; D005680:gamma-Aminobutyric Acid
chemical_list: D000085:Acetates; D000588:Amines; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin