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A randomized, double-blind, placebo-controlled, ascending-dose tolerability and safety study of remacemide as adjuvant therapy in parkinson's disease with response fluctuations. SUMMARY: The objective of this study was to establish the maximum tolerated dose of the low affinity non-competitive N-methyl-D-aspartate receptor antagonist remacemide in patients who have Parkinson's disease with response fluctuations or dyskinesias, or both. A total of 33 patients were randomly assigned in a 3-to-1 ratio to receive remacemide or placebo. remacemide was administered orally at 150 mg twice daily, increasing incrementally by 100 mg (50 mg twice daily) at 2-week intervals to a final daily regimen of 400 mg twice daily or until a maximum tolerated dose was identified. The maximum total treatment period was 12 weeks. Of the 23 patients randomly selected to receive remacemide, four completed the study at the maximum permitted dose, compared with four of the 10 patients given placebo. The median maximum tolerated dose of remacemide was 450 mg/d. There was no clinically relevant change in percentage of "on" time between baseline and maximum tolerated dose in either group. At the maximum tolerated dose of remacemide for each patient, the mean Unified Parkinson's Disease Rating Scale (UPDRS) motor examination score (part III) decreased from 33 (SD = 18) to 26 (SD = 13) compared with a decrease from 28 (SD = 12) to 27 (SD = 8) in the placebo group. There was a decrease in the mean UPDRS "complications of therapy" score (part IV) in the remacemide group from 8 (SD = 4) to 6 (SD = 4), and the placebo group remained unchanged at 6 (SD = 4). The most common adverse events associated with remacemide were nausea, vomiting, dizziness, headache, abnormal vision, and hypokinesia. Remacemide was well tolerated at a dose level of 400 mg/d. There was a trend suggesting that remacemide was effective in improving symptoms at patients' individual maximum tolerated doses. These improvements occurred without exacerbating levodopa-induced dyskinesias. Clarke CE, Cooper JA, Holdich TA. Department of Neurology, City Hospital, Birmingham; Lundbeck Limited, Sunningdale House, Milton Keynes; and AstraZeneca, Loughborough, United Kingdom. Clin Neuropharmacol 2001 May-Jun;24(3):133-8 PMID: 11391123 janet paterson: an akinetic rigid subtype, albeit perky, parky . pd: 54/41/37 cd: 54/44/43 tel: 613 256 8340 email: [log in to unmask] . snail mail: 375 Country Street, Apt 301, Almonte, Ontario, Canada, K0A 1A0 . a new voice: the nnnewsletter: http://groups.yahoo.com/group/janet313/ . a new voice: the wwweb site: http://www.geocities.com/janet313/ . ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn