This category D study evaluated the effectiveness of CEB-1050 (amantadine hydrochloride) in thirty-nine subjects with autism. Amantadine hydrochloride had been found to have non-competitive NMD antagonistic activity at doses used for its prescribed indications for the treatment of influenza, herpes zoster, and Parkinson's disease. A number of anticonvulsants have also been shown to be NMD antagonists, and some studies have reported that amantadine may have utility in the treatment of child epilepsy. Scattered reports have also suggested that amantadine may be effective in the treatment of hyperactivity states. These preliminary data about the effects of amantadine on behavioral and neurophysiologic parameters suggested that it might have some effectiveness in children with autism. This was a randomized study, and was blinded. All data collected have been submitted to the sponsor, and a manuscript has been submitted for publication, suggesting a moderate beneficial effect for amantadine in the treatment of autism.
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