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Treatment of partial seizures with gabapentin: double-blind, placebo-controlled, parallel-group study.
Psychiatry Clin Neurosci. 2006 Aug; 60(4):507-15.PC

Abstract

This double-blind study was conducted to evaluate the efficacy and safety of gabapentin 1200 mg/day and 1800 mg/day (t.i.d.) compared to placebo as an adjunctive therapy in patients with refractory epilepsy. Patients were included when they had partial seizures at least eight times during a 12-week baseline period despite treatment with one to two antiepileptic drugs. After baseline, eligible patients were randomized to gabapentin 1200 mg/day, 1800 mg/day, or placebo for 12-week treatment. The primary end-point, response ratio, was derived from seizure frequencies during treatment and baseline period based upon the seizure daily record by a patient. Of the 209 randomized patients, 86 received gabapentin 1200 mg/day, 41 received gabapentin 1800 mg/day, and 82 received placebo. A statistically significant difference was found between each of the two gabapentin groups and placebo for the primary efficacy end-point, response ratio (P < 0.005) with definite dose-response (P < 0.001). More gabapentin patients reported moderate to marked improvement in seizure frequency and intensity/duration of each seizure than placebo patients. Treatment-related adverse events were reported by approximately 65% of patients receiving gabapentin compared to approximately 46% of patients receiving placebo; somnolence and dizziness were the most common events. Gabapentin 1200 mg/day and 1800 mg/day significantly reduced the frequency of refractory seizures compared to placebo. Favorable tolerability of gabapentin was confirmed also in a Japanese population, consistent with previous global studies.

Authors+Show Affiliations

Saitama Medical School, Saitama, Japan. tyamachi@saitama-med.ac.jpNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16884455

Citation

Yamauchi, Toshio, et al. "Treatment of Partial Seizures With Gabapentin: Double-blind, Placebo-controlled, Parallel-group Study." Psychiatry and Clinical Neurosciences, vol. 60, no. 4, 2006, pp. 507-15.
Yamauchi T, Kaneko S, Yagi K, et al. Treatment of partial seizures with gabapentin: double-blind, placebo-controlled, parallel-group study. Psychiatry Clin Neurosci. 2006;60(4):507-15.
Yamauchi, T., Kaneko, S., Yagi, K., & Sase, S. (2006). Treatment of partial seizures with gabapentin: double-blind, placebo-controlled, parallel-group study. Psychiatry and Clinical Neurosciences, 60(4), 507-15.
Yamauchi T, et al. Treatment of Partial Seizures With Gabapentin: Double-blind, Placebo-controlled, Parallel-group Study. Psychiatry Clin Neurosci. 2006;60(4):507-15. PubMed PMID: 16884455.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment of partial seizures with gabapentin: double-blind, placebo-controlled, parallel-group study. AU - Yamauchi,Toshio, AU - Kaneko,Sunao, AU - Yagi,Kazuichi, AU - Sase,Shinichi, PY - 2006/8/4/pubmed PY - 2006/9/21/medline PY - 2006/8/4/entrez SP - 507 EP - 15 JF - Psychiatry and clinical neurosciences JO - Psychiatry Clin Neurosci VL - 60 IS - 4 N2 - This double-blind study was conducted to evaluate the efficacy and safety of gabapentin 1200 mg/day and 1800 mg/day (t.i.d.) compared to placebo as an adjunctive therapy in patients with refractory epilepsy. Patients were included when they had partial seizures at least eight times during a 12-week baseline period despite treatment with one to two antiepileptic drugs. After baseline, eligible patients were randomized to gabapentin 1200 mg/day, 1800 mg/day, or placebo for 12-week treatment. The primary end-point, response ratio, was derived from seizure frequencies during treatment and baseline period based upon the seizure daily record by a patient. Of the 209 randomized patients, 86 received gabapentin 1200 mg/day, 41 received gabapentin 1800 mg/day, and 82 received placebo. A statistically significant difference was found between each of the two gabapentin groups and placebo for the primary efficacy end-point, response ratio (P < 0.005) with definite dose-response (P < 0.001). More gabapentin patients reported moderate to marked improvement in seizure frequency and intensity/duration of each seizure than placebo patients. Treatment-related adverse events were reported by approximately 65% of patients receiving gabapentin compared to approximately 46% of patients receiving placebo; somnolence and dizziness were the most common events. Gabapentin 1200 mg/day and 1800 mg/day significantly reduced the frequency of refractory seizures compared to placebo. Favorable tolerability of gabapentin was confirmed also in a Japanese population, consistent with previous global studies. SN - 1323-1316 UR - https://www.unboundmedicine.com/medline/citation/16884455/Treatment_of_partial_seizures_with_gabapentin:_double_blind_placebo_controlled_parallel_group_study_ L2 - https://doi.org/10.1111/j.1440-1819.2006.01553.x DB - PRIME DP - Unbound Medicine ER -