OBJECTIVE: To determine whether chronic treatment with celecoxib, a 
cyclooxygenase-2 inhibitor that has been shown to be beneficial in preclinical 
testing, is safe and effective in amyotrophic lateral sclerosis (ALS).
METHODS: A double-blind, placebo-controlled, clinical trial was conducted. Three 
hundred research subjects with ALS were randomized (2:1) to receive celecoxib 
(800 mg/day) or placebo for 12 months. The primary outcome measure was the rate 
of change in upper extremity motor function measured by the maximum voluntary 
isometric contraction strength. Secondary end points included safety, survival, 
change in cerebrospinal fluid prostaglandin E(2) levels, and changes in the rate 
of decline of leg and grip strength, vital capacity, ALS Functional Rating 
Scale-Revised, and motor unit number estimates.
RESULTS: Celecoxib did not slow the decline in muscle strength, vital capacity, 
motor unit number estimates, ALS Functional Rating Scale-Revised, or affect 
survival. Celecoxib was well tolerated and was not associated with an increased 
frequency of adverse events. Prostaglandin E(2) levels in cerebrospinal fluid 
were not elevated at baseline and did not decline with treatment.
INTERPRETATION: At the dosage studied, celecoxib did not have a beneficial 
effect on research subjects with ALS, and it was safe. A biological effect of 
celecoxib was not demonstrated in the cerebrospinal fluid. Further studies of 
celecoxib at a dosage of 800 mg/day in ALS are not warranted.