To: Dr. John M. de Castro who wrote (690 ) 10/20/1999 9:01:00 PM From: JMarcus Read Replies (1) | Respond to
Just finished a most pleasant conversation with a staff member of NTII. She is currently analyzing the data from the diabetic neuropathy Phase II trial, which has just recently been completed. She hopes to have results by the end of the year and sounded most optimistic. The Phase IIA trial had enrolled 122 patients, about 70 of whom suffered from diabetic neuropathy and the rest from post herpetic neurolgia (please forgive any misspellings; I don't have a medical dictionary handy). Memantine was not useful against herpetic neurolgia but showed promise for diabetic neuropathy. However, the study was not statistically powered - 60% of the 70+ diabetic neuropathy patients received placebo and only 40% received Memantine. The new Phase IIB trial enrolled 375 diabetic neuropathy patients, 80% of whom received Memantine and only 20% placebo. Half of the Memantine patients received a 20 mg. dose and the other half received a 40 mg. dose. The only dose used in Phase IIA was 40 mg. The lower dose is being examined because it would be nice to reduce the one side effect of Memantine, which is dizziness. Their trials have been successful at moderating this side effect by titrating the patients, starting them out at lower doses and then gradually building them up to the higher dose. She said that there was a lower frequency of reports of dizziness in the Phase IIB trial, so apparently the lower dose makes a difference on the side effect profile.
