Loading…

Remacemide hydrochloride as an add-on therapy in epilepsy: a randomized, placebo-controlled trial of three dose levels (300, 600 and 800 mg / day) in a B.I.D. regimen

Remacemide hydrochloride is a low-affinity, non-competitive NMDA receptor channel blocker under investigation for the treatment of epilepsy. This double-blind, placebo-controlled, multicentre study assessed the safety and efficacy of adjunctive remacemide hydrochloride or placebo, in adult patients...

Full description

Saved in:
Bibliographic Details
Published in:Seizure (London, England) England), 2002-03, Vol.11 (2), p.104-113
Main Authors: Jones, M.W, Blume, W.T, Guberman, A, Lee, M.A, Pillay, N, Weaver, D.F, Veloso, F, Holdich, T.A.H
Format: Article
Language:English
Subjects:
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by cdi_FETCH-LOGICAL-c380t-a3140b787ccb1ea5ea445ab22df57208d958dc810a69171d8cd67f1812b4dac73
cites cdi_FETCH-LOGICAL-c380t-a3140b787ccb1ea5ea445ab22df57208d958dc810a69171d8cd67f1812b4dac73
container_end_page 113
container_issue 2
container_start_page 104
container_title Seizure (London, England)
container_volume 11
creator Jones, M.W
Blume, W.T
Guberman, A
Lee, M.A
Pillay, N
Weaver, D.F
Veloso, F
Holdich, T.A.H
description Remacemide hydrochloride is a low-affinity, non-competitive NMDA receptor channel blocker under investigation for the treatment of epilepsy. This double-blind, placebo-controlled, multicentre study assessed the safety and efficacy of adjunctive remacemide hydrochloride or placebo, in adult patients with refractory epilepsy who were already taking up to three antiepileptic drugs (including an enzyme-inducer). Patients (n= 262) were randomized to one of three doses of remacemide hydrochloride (300, 600 or 800 mg/day) or placebo, in a B.I.D. regimen, for up to 14 weeks. Plasma concentrations of carbamazepine (CBZ) and phenytoin (PHT) were controlled throughout. Patients recorded their seizures on a diary card. There was an increase in the percentage of responders (defined as a reduction in seizure frequency from baseline ≥ 50 %), from 15 %(9/60) with placebo, to 30% (18/60) in the 800 mg/day group. A pairwise comparison between remacemide hydrochloride 800 mg/day and placebo was statistically significant (P= 0.049). Most reported adverse events (mainly CNS and gastrointestinal) were mild or moderate in severity and dose-dependent. Adjunctive remacemide hydrochloride treatment was associated with a higher, dose-related responder rate compared with placebo. The difference reached significance at the highest dose tested (800 mg/day). Remacemide hydrochloride was well tolerated.
doi_str_mv 10.1053/seiz.2002.0589
format article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_71605859</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1059131102905893</els_id><sourcerecordid>71605859</sourcerecordid><originalsourceid>FETCH-LOGICAL-c380t-a3140b787ccb1ea5ea445ab22df57208d958dc810a69171d8cd67f1812b4dac73</originalsourceid><addsrcrecordid>eNp1kUFr1UAQx4MotrZePcqcRKFJd5NssvGmVWuhUBA9L5udSd_KJht38wrpB_JzuuE98NTTzMBv_gPzy7I3nBWcieoykn0sSsbKggnZPctOuajKvGykfJ56JrqcV5yfZK9i_M0Y62pevcxOOO9qwbr2NPv7g0ZtaLRIsFsxeLNzPmyTjqAn0Ii5n2DZUdDzCnYCmq2jOa4fQUPQE_rRPhJewOxSTu9z46cleOcIYQlWO_BDWg9EgD4SOHogF-F9xdgFNIylIwgy1fEeLgH1-mE7ouFzcVN8KSDQvR1pOs9eDNpFen2sZ9mvb19_Xn3Pb--ub64-3eamkmzJdcVr1reyNabnpAXpuha6L0scRFsyiZ2QaCRnuul4y1EabNqBS172NWrTVmfZu0PuHPyfPcVFjTYack5P5PdRtbxJfxZdAosDaIKPMdCg5mBHHVbFmdrMqM2M2syozUxaeHtM3vcj4X_8qCIB8gCk99CDpaCisTQZQhvILAq9fSr7H1gbm6M</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>71605859</pqid></control><display><type>article</type><title>Remacemide hydrochloride as an add-on therapy in epilepsy: a randomized, placebo-controlled trial of three dose levels (300, 600 and 800 mg / day) in a B.I.D. regimen</title><source>Elsevier</source><creator>Jones, M.W ; Blume, W.T ; Guberman, A ; Lee, M.A ; Pillay, N ; Weaver, D.F ; Veloso, F ; Holdich, T.A.H</creator><creatorcontrib>Jones, M.W ; Blume, W.T ; Guberman, A ; Lee, M.A ; Pillay, N ; Weaver, D.F ; Veloso, F ; Holdich, T.A.H</creatorcontrib><description>Remacemide hydrochloride is a low-affinity, non-competitive NMDA receptor channel blocker under investigation for the treatment of epilepsy. This double-blind, placebo-controlled, multicentre study assessed the safety and efficacy of adjunctive remacemide hydrochloride or placebo, in adult patients with refractory epilepsy who were already taking up to three antiepileptic drugs (including an enzyme-inducer). Patients (n= 262) were randomized to one of three doses of remacemide hydrochloride (300, 600 or 800 mg/day) or placebo, in a B.I.D. regimen, for up to 14 weeks. Plasma concentrations of carbamazepine (CBZ) and phenytoin (PHT) were controlled throughout. Patients recorded their seizures on a diary card. There was an increase in the percentage of responders (defined as a reduction in seizure frequency from baseline ≥ 50 %), from 15 %(9/60) with placebo, to 30% (18/60) in the 800 mg/day group. A pairwise comparison between remacemide hydrochloride 800 mg/day and placebo was statistically significant (P= 0.049). Most reported adverse events (mainly CNS and gastrointestinal) were mild or moderate in severity and dose-dependent. Adjunctive remacemide hydrochloride treatment was associated with a higher, dose-related responder rate compared with placebo. The difference reached significance at the highest dose tested (800 mg/day). Remacemide hydrochloride was well tolerated.</description><identifier>ISSN: 1059-1311</identifier><identifier>EISSN: 1532-2688</identifier><identifier>DOI: 10.1053/seiz.2002.0589</identifier><identifier>PMID: 11945097</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Acetamides - administration &amp; dosage ; Acetamides - blood ; add-on therapy ; Adolescent ; Adult ; Aged ; Anticonvulsants - administration &amp; dosage ; Anticonvulsants - blood ; antiepileptic drugs ; Carbamazepine - administration &amp; dosage ; Carbamazepine - blood ; Chi-Square Distribution ; clinical trials ; Confidence Intervals ; dose-ranging ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination ; Epilepsy - blood ; Epilepsy - drug therapy ; Female ; Humans ; Male ; Middle Aged ; Outcome Assessment (Health Care) ; Phenytoin - administration &amp; dosage ; Phenytoin - blood ; remacemide</subject><ispartof>Seizure (London, England), 2002-03, Vol.11 (2), p.104-113</ispartof><rights>2002 BEA Trading, Ltd</rights><rights>Copyright 2002 BEA Trading Ltd. Published by Elsevier Science Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c380t-a3140b787ccb1ea5ea445ab22df57208d958dc810a69171d8cd67f1812b4dac73</citedby><cites>FETCH-LOGICAL-c380t-a3140b787ccb1ea5ea445ab22df57208d958dc810a69171d8cd67f1812b4dac73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11945097$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jones, M.W</creatorcontrib><creatorcontrib>Blume, W.T</creatorcontrib><creatorcontrib>Guberman, A</creatorcontrib><creatorcontrib>Lee, M.A</creatorcontrib><creatorcontrib>Pillay, N</creatorcontrib><creatorcontrib>Weaver, D.F</creatorcontrib><creatorcontrib>Veloso, F</creatorcontrib><creatorcontrib>Holdich, T.A.H</creatorcontrib><title>Remacemide hydrochloride as an add-on therapy in epilepsy: a randomized, placebo-controlled trial of three dose levels (300, 600 and 800 mg / day) in a B.I.D. regimen</title><title>Seizure (London, England)</title><addtitle>Seizure</addtitle><description>Remacemide hydrochloride is a low-affinity, non-competitive NMDA receptor channel blocker under investigation for the treatment of epilepsy. This double-blind, placebo-controlled, multicentre study assessed the safety and efficacy of adjunctive remacemide hydrochloride or placebo, in adult patients with refractory epilepsy who were already taking up to three antiepileptic drugs (including an enzyme-inducer). Patients (n= 262) were randomized to one of three doses of remacemide hydrochloride (300, 600 or 800 mg/day) or placebo, in a B.I.D. regimen, for up to 14 weeks. Plasma concentrations of carbamazepine (CBZ) and phenytoin (PHT) were controlled throughout. Patients recorded their seizures on a diary card. There was an increase in the percentage of responders (defined as a reduction in seizure frequency from baseline ≥ 50 %), from 15 %(9/60) with placebo, to 30% (18/60) in the 800 mg/day group. A pairwise comparison between remacemide hydrochloride 800 mg/day and placebo was statistically significant (P= 0.049). Most reported adverse events (mainly CNS and gastrointestinal) were mild or moderate in severity and dose-dependent. Adjunctive remacemide hydrochloride treatment was associated with a higher, dose-related responder rate compared with placebo. The difference reached significance at the highest dose tested (800 mg/day). Remacemide hydrochloride was well tolerated.</description><subject>Acetamides - administration &amp; dosage</subject><subject>Acetamides - blood</subject><subject>add-on therapy</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Anticonvulsants - administration &amp; dosage</subject><subject>Anticonvulsants - blood</subject><subject>antiepileptic drugs</subject><subject>Carbamazepine - administration &amp; dosage</subject><subject>Carbamazepine - blood</subject><subject>Chi-Square Distribution</subject><subject>clinical trials</subject><subject>Confidence Intervals</subject><subject>dose-ranging</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug Therapy, Combination</subject><subject>Epilepsy - blood</subject><subject>Epilepsy - drug therapy</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Outcome Assessment (Health Care)</subject><subject>Phenytoin - administration &amp; dosage</subject><subject>Phenytoin - blood</subject><subject>remacemide</subject><issn>1059-1311</issn><issn>1532-2688</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><recordid>eNp1kUFr1UAQx4MotrZePcqcRKFJd5NssvGmVWuhUBA9L5udSd_KJht38wrpB_JzuuE98NTTzMBv_gPzy7I3nBWcieoykn0sSsbKggnZPctOuajKvGykfJ56JrqcV5yfZK9i_M0Y62pevcxOOO9qwbr2NPv7g0ZtaLRIsFsxeLNzPmyTjqAn0Ii5n2DZUdDzCnYCmq2jOa4fQUPQE_rRPhJewOxSTu9z46cleOcIYQlWO_BDWg9EgD4SOHogF-F9xdgFNIylIwgy1fEeLgH1-mE7ouFzcVN8KSDQvR1pOs9eDNpFen2sZ9mvb19_Xn3Pb--ub64-3eamkmzJdcVr1reyNabnpAXpuha6L0scRFsyiZ2QaCRnuul4y1EabNqBS172NWrTVmfZu0PuHPyfPcVFjTYack5P5PdRtbxJfxZdAosDaIKPMdCg5mBHHVbFmdrMqM2M2syozUxaeHtM3vcj4X_8qCIB8gCk99CDpaCisTQZQhvILAq9fSr7H1gbm6M</recordid><startdate>20020301</startdate><enddate>20020301</enddate><creator>Jones, M.W</creator><creator>Blume, W.T</creator><creator>Guberman, A</creator><creator>Lee, M.A</creator><creator>Pillay, N</creator><creator>Weaver, D.F</creator><creator>Veloso, F</creator><creator>Holdich, T.A.H</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20020301</creationdate><title>Remacemide hydrochloride as an add-on therapy in epilepsy: a randomized, placebo-controlled trial of three dose levels (300, 600 and 800 mg / day) in a B.I.D. regimen</title><author>Jones, M.W ; Blume, W.T ; Guberman, A ; Lee, M.A ; Pillay, N ; Weaver, D.F ; Veloso, F ; Holdich, T.A.H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c380t-a3140b787ccb1ea5ea445ab22df57208d958dc810a69171d8cd67f1812b4dac73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Acetamides - administration &amp; dosage</topic><topic>Acetamides - blood</topic><topic>add-on therapy</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Anticonvulsants - administration &amp; dosage</topic><topic>Anticonvulsants - blood</topic><topic>antiepileptic drugs</topic><topic>Carbamazepine - administration &amp; dosage</topic><topic>Carbamazepine - blood</topic><topic>Chi-Square Distribution</topic><topic>clinical trials</topic><topic>Confidence Intervals</topic><topic>dose-ranging</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug Therapy, Combination</topic><topic>Epilepsy - blood</topic><topic>Epilepsy - drug therapy</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Outcome Assessment (Health Care)</topic><topic>Phenytoin - administration &amp; dosage</topic><topic>Phenytoin - blood</topic><topic>remacemide</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jones, M.W</creatorcontrib><creatorcontrib>Blume, W.T</creatorcontrib><creatorcontrib>Guberman, A</creatorcontrib><creatorcontrib>Lee, M.A</creatorcontrib><creatorcontrib>Pillay, N</creatorcontrib><creatorcontrib>Weaver, D.F</creatorcontrib><creatorcontrib>Veloso, F</creatorcontrib><creatorcontrib>Holdich, T.A.H</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Seizure (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jones, M.W</au><au>Blume, W.T</au><au>Guberman, A</au><au>Lee, M.A</au><au>Pillay, N</au><au>Weaver, D.F</au><au>Veloso, F</au><au>Holdich, T.A.H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Remacemide hydrochloride as an add-on therapy in epilepsy: a randomized, placebo-controlled trial of three dose levels (300, 600 and 800 mg / day) in a B.I.D. regimen</atitle><jtitle>Seizure (London, England)</jtitle><addtitle>Seizure</addtitle><date>2002-03-01</date><risdate>2002</risdate><volume>11</volume><issue>2</issue><spage>104</spage><epage>113</epage><pages>104-113</pages><issn>1059-1311</issn><eissn>1532-2688</eissn><abstract>Remacemide hydrochloride is a low-affinity, non-competitive NMDA receptor channel blocker under investigation for the treatment of epilepsy. This double-blind, placebo-controlled, multicentre study assessed the safety and efficacy of adjunctive remacemide hydrochloride or placebo, in adult patients with refractory epilepsy who were already taking up to three antiepileptic drugs (including an enzyme-inducer). Patients (n= 262) were randomized to one of three doses of remacemide hydrochloride (300, 600 or 800 mg/day) or placebo, in a B.I.D. regimen, for up to 14 weeks. Plasma concentrations of carbamazepine (CBZ) and phenytoin (PHT) were controlled throughout. Patients recorded their seizures on a diary card. There was an increase in the percentage of responders (defined as a reduction in seizure frequency from baseline ≥ 50 %), from 15 %(9/60) with placebo, to 30% (18/60) in the 800 mg/day group. A pairwise comparison between remacemide hydrochloride 800 mg/day and placebo was statistically significant (P= 0.049). Most reported adverse events (mainly CNS and gastrointestinal) were mild or moderate in severity and dose-dependent. Adjunctive remacemide hydrochloride treatment was associated with a higher, dose-related responder rate compared with placebo. The difference reached significance at the highest dose tested (800 mg/day). Remacemide hydrochloride was well tolerated.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>11945097</pmid><doi>10.1053/seiz.2002.0589</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 1059-1311
ispartof Seizure (London, England), 2002-03, Vol.11 (2), p.104-113
issn 1059-1311
1532-2688
language eng
recordid cdi_proquest_miscellaneous_71605859
source Elsevier
subjects Acetamides - administration & dosage
Acetamides - blood
add-on therapy
Adolescent
Adult
Aged
Anticonvulsants - administration & dosage
Anticonvulsants - blood
antiepileptic drugs
Carbamazepine - administration & dosage
Carbamazepine - blood
Chi-Square Distribution
clinical trials
Confidence Intervals
dose-ranging
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Epilepsy - blood
Epilepsy - drug therapy
Female
Humans
Male
Middle Aged
Outcome Assessment (Health Care)
Phenytoin - administration & dosage
Phenytoin - blood
remacemide
title Remacemide hydrochloride as an add-on therapy in epilepsy: a randomized, placebo-controlled trial of three dose levels (300, 600 and 800 mg / day) in a B.I.D. regimen
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-25T17%3A10%3A18IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Remacemide%20hydrochloride%20as%20an%20add-on%20therapy%20in%20epilepsy:%20a%20randomized,%20placebo-controlled%20trial%20of%20three%20dose%20levels%20(300,%20600%20and%20800%20mg%20/%20day)%20in%20a%20B.I.D.%20regimen&rft.jtitle=Seizure%20(London,%20England)&rft.au=Jones,%20M.W&rft.date=2002-03-01&rft.volume=11&rft.issue=2&rft.spage=104&rft.epage=113&rft.pages=104-113&rft.issn=1059-1311&rft.eissn=1532-2688&rft_id=info:doi/10.1053/seiz.2002.0589&rft_dat=%3Cproquest_cross%3E71605859%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c380t-a3140b787ccb1ea5ea445ab22df57208d958dc810a69171d8cd67f1812b4dac73%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=71605859&rft_id=info:pmid/11945097&rfr_iscdi=true