TY - JOUR
T1 - A randomized, controlled trial of remacemide for motor fluctuations in parkinson’s disease
AU - Parkinson study group
AU - Shoulson, Ira
AU - Penney, John
AU - McDermott, Michael
AU - Kieburtz, Karl
AU - Schwid, Steven R.
AU - Kayson, Elise
AU - Chase, Thomas
AU - Fahn, Stanley
AU - Timothy Greenamyre, J.
AU - Lang, Anthony
AU - Siderowf, Andrew
AU - Pearson, Nancy
AU - Harrison, Madeline
AU - Rost–Ruffner, Elke
AU - Colcher, Amy
AU - Lloyd, Mary
AU - Matthews, Mary
AU - Pahwa, Rajesh
AU - McGuire, Desni
AU - Lew, Mark F.
AU - Schuman, Suzanne
AU - Marek, Kenneth
AU - Broshjeit, Susan
AU - Factor, Stewart
AU - Brown, Diane
AU - Feigin, Andrew
AU - Mazurkiewicz, Jennifer
AU - Ford, Blair
AU - Jennings, Danna
AU - Dillon, Sandra
AU - Comella, Cynthia
AU - Blasucci, Lucy
AU - Janko, Kimberly
AU - Shulman, Lisa
AU - Wiener, William
AU - Bateman–Rodriguez, Dinorah
AU - Carrion, Arleace
AU - Suchowersky, Oksana
AU - Lafontaine, Ann Louise
AU - Pantella, Carol
AU - Siemers, Eric
AU - Belden, Joann
AU - Davies, Robin
AU - Lannon, Margaret
AU - Grimes, David
AU - Gray, Peggy
AU - Martin, Wayne
AU - Kennedy, Lori
AU - Adler, Charles
AU - Hammerstad, John
N1 - Publisher Copyright:
© 2001 by AAN Enterprises, Inc.
PY - 2001/8/14
Y1 - 2001/8/14
N2 - Background: Preclinical studies suggest that glutamate antagonists help ameliorate motor fluctuations in patients with PD treated with levodopa. Methods: In a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study, the authors assessed the safety, tolerability, and efficacy of the glutamate receptor blocker remacemide hydrochloride in 279 patients with motor fluctuations treated with levodopa. The primary objective was to assess the short-term tolerability and safety of four dosage levels of remacemide during 7 weeks of treatment. Patients were also monitored with home diaries and the Unified PD Rating Scale (UPDRS) to collect preliminary data on treatment efficacy. Results: Remacemide was well tolerated up to a dosage of 300 mg/d on a twice daily schedule and 600 mg/d on a four times daily schedule. The most common dosage-related adverse events were dizziness and nausea, as observed in previous studies of remacemide. The percent “on” time and motor UPDRS scores showed trends toward improvement in the patients treated with 150 and 300 mg/d remacemide compared with placebo-treated patients, although these improvements were not significant. Conclusion: Remacemide is a safe and tolerable adjunct to dopaminergic therapy for patients with PD and motor fluctuations. Although this study had limited power to detect therapeutic effects, the observed improvement is consistent with studies of non-human primates with 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-induced parkinsonian signs and symptoms. Additional studies are warranted to confirm these results over an extended period of observation, and to explore the potential neuroprotective effects of remacemide in slowing the progression of PD.
AB - Background: Preclinical studies suggest that glutamate antagonists help ameliorate motor fluctuations in patients with PD treated with levodopa. Methods: In a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study, the authors assessed the safety, tolerability, and efficacy of the glutamate receptor blocker remacemide hydrochloride in 279 patients with motor fluctuations treated with levodopa. The primary objective was to assess the short-term tolerability and safety of four dosage levels of remacemide during 7 weeks of treatment. Patients were also monitored with home diaries and the Unified PD Rating Scale (UPDRS) to collect preliminary data on treatment efficacy. Results: Remacemide was well tolerated up to a dosage of 300 mg/d on a twice daily schedule and 600 mg/d on a four times daily schedule. The most common dosage-related adverse events were dizziness and nausea, as observed in previous studies of remacemide. The percent “on” time and motor UPDRS scores showed trends toward improvement in the patients treated with 150 and 300 mg/d remacemide compared with placebo-treated patients, although these improvements were not significant. Conclusion: Remacemide is a safe and tolerable adjunct to dopaminergic therapy for patients with PD and motor fluctuations. Although this study had limited power to detect therapeutic effects, the observed improvement is consistent with studies of non-human primates with 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-induced parkinsonian signs and symptoms. Additional studies are warranted to confirm these results over an extended period of observation, and to explore the potential neuroprotective effects of remacemide in slowing the progression of PD.
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U2 - 10.1212/WNL.56.4.455
DO - 10.1212/WNL.56.4.455
M3 - Article
C2 - 11502903
AN - SCOPUS:0035957065
SN - 0028-3878
VL - 56
SP - 455
EP - 462
JO - Neurology
JF - Neurology
IS - 4
ER -