Treatment of essential tremor with the barbiturate T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid).
Identifieur interne : 001A68 ( Ncbi/Merge ); précédent : 001A67; suivant : 001A69Treatment of essential tremor with the barbiturate T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid).
Auteurs : Calvin Melmed [Canada] ; Daniel Moros ; Howard RutmanSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2007.
English descriptors
- KwdEn :
- Adult, Barbiturates (administration & dosage), Barbiturates (adverse effects), Barbiturates (pharmacokinetics), Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Essential Tremor (blood), Essential Tremor (drug therapy), Female, Humans, Male, Middle Aged, Neurologic Examination, Phenobarbital (administration & dosage), Phenobarbital (adverse effects), Phenobarbital (analogs & derivatives), Phenobarbital (pharmacokinetics).
- MESH :
- chemical , administration & dosage : Barbiturates, Phenobarbital.
- chemical , adverse effects : Barbiturates, Phenobarbital.
- chemical , analogs & derivatives : Phenobarbital.
- chemical , pharmacokinetics : Barbiturates, Phenobarbital.
- blood : Essential Tremor.
- drug therapy : Essential Tremor.
- Adult, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Neurologic Examination.
Abstract
The effect of the barbiturate T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid; DMMDPB) on essential tremor, given in twice daily doses of 400 and 300 mg, was assessed in two brief, randomized, placebo-controlled, parallel-group, double-blinded, single-center trials in 12 and 22 patients, respectively. These trials represent the first clinical use of T2000 for a specific indication. The primary endpoint was the change in the mean scores of the treated and control groups based on the Fahn-Tolosa-Marin tremor scale. In the first study of 12 patients treated with 400 mg or placebo twice daily for 14 days, the mean change from baseline at day 14 was 19.3 (P < 0.0001) in the treated group and 9.0 (P = 0.0121) in the control group. Using a two-factor mixed ANOVA model to evaluate within group and between group changes, the effect of T2000 was significantly different from that of the placebo group (P = 0.03). In the second study of 22 patients treated with 300 mg of T2000 or placebo twice daily for 20 days, statistically significant changes were seen in treated patients compared to baseline, but the ANOVA model did not demonstrate a significant treatment effect of T2000 compared to placebo. When the treated groups from each study are compared, the 800-mg daily group is significantly different from the 600-mg daily group (P = 0.02). Some treated patients in each study, but no placebo patients, experienced marked improvement. These results support further evaluation of T2000 in the treatment of essential tremor.
DOI: 10.1002/mds.21321
PubMed: 17265458
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pubmed:17265458Le document en format XML
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<author><name sortKey="Melmed, Calvin" sort="Melmed, Calvin" uniqKey="Melmed C" first="Calvin" last="Melmed">Calvin Melmed</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec</wicri:regionArea>
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<author><name sortKey="Moros, Daniel" sort="Moros, Daniel" uniqKey="Moros D" first="Daniel" last="Moros">Daniel Moros</name>
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<author><name sortKey="Rutman, Howard" sort="Rutman, Howard" uniqKey="Rutman H" first="Howard" last="Rutman">Howard Rutman</name>
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<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Drug Administration Schedule</term>
<term>Essential Tremor (blood)</term>
<term>Essential Tremor (drug therapy)</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neurologic Examination</term>
<term>Phenobarbital (administration & dosage)</term>
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<term>Phenobarbital (analogs & derivatives)</term>
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<term>Phenobarbital</term>
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<front><div type="abstract" xml:lang="en">The effect of the barbiturate T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid; DMMDPB) on essential tremor, given in twice daily doses of 400 and 300 mg, was assessed in two brief, randomized, placebo-controlled, parallel-group, double-blinded, single-center trials in 12 and 22 patients, respectively. These trials represent the first clinical use of T2000 for a specific indication. The primary endpoint was the change in the mean scores of the treated and control groups based on the Fahn-Tolosa-Marin tremor scale. In the first study of 12 patients treated with 400 mg or placebo twice daily for 14 days, the mean change from baseline at day 14 was 19.3 (P < 0.0001) in the treated group and 9.0 (P = 0.0121) in the control group. Using a two-factor mixed ANOVA model to evaluate within group and between group changes, the effect of T2000 was significantly different from that of the placebo group (P = 0.03). In the second study of 22 patients treated with 300 mg of T2000 or placebo twice daily for 20 days, statistically significant changes were seen in treated patients compared to baseline, but the ANOVA model did not demonstrate a significant treatment effect of T2000 compared to placebo. When the treated groups from each study are compared, the 800-mg daily group is significantly different from the 600-mg daily group (P = 0.02). Some treated patients in each study, but no placebo patients, experienced marked improvement. These results support further evaluation of T2000 in the treatment of essential tremor.</div>
</front>
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<ArticleTitle>Treatment of essential tremor with the barbiturate T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid).</ArticleTitle>
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<Abstract><AbstractText>The effect of the barbiturate T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid; DMMDPB) on essential tremor, given in twice daily doses of 400 and 300 mg, was assessed in two brief, randomized, placebo-controlled, parallel-group, double-blinded, single-center trials in 12 and 22 patients, respectively. These trials represent the first clinical use of T2000 for a specific indication. The primary endpoint was the change in the mean scores of the treated and control groups based on the Fahn-Tolosa-Marin tremor scale. In the first study of 12 patients treated with 400 mg or placebo twice daily for 14 days, the mean change from baseline at day 14 was 19.3 (P < 0.0001) in the treated group and 9.0 (P = 0.0121) in the control group. Using a two-factor mixed ANOVA model to evaluate within group and between group changes, the effect of T2000 was significantly different from that of the placebo group (P = 0.03). In the second study of 22 patients treated with 300 mg of T2000 or placebo twice daily for 20 days, statistically significant changes were seen in treated patients compared to baseline, but the ANOVA model did not demonstrate a significant treatment effect of T2000 compared to placebo. When the treated groups from each study are compared, the 800-mg daily group is significantly different from the 600-mg daily group (P = 0.02). Some treated patients in each study, but no placebo patients, experienced marked improvement. These results support further evaluation of T2000 in the treatment of essential tremor.</AbstractText>
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