The current study evaluated under double-blind placebo-controlled conditions, the safety and efficacy of 400 mg pramiracetam sulphate TID in treating memory and other cognitive problems of males who have sustained brain injuries. The results of the study indicate that subject performance in measures of memory, especially delayed recall, evidenced clinically significant improvements after the administration of pramiracetam sulphate as compared to placebo. This improvement was maintained during an 18-month open-trial period on the medication as well as during a 1-month follow-up period after the pramiracetam was discontinued.