Compliance With Once-Daily Divalproex Extended-Release Tablets (Depakote-ER) Versus Multiple-Daily Dose Valproic Acid Capsules (Depakene) in Epilepsy: A Randomized, Parallel, Prospectively-Controlled Outpatient Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
研究概览
简要总结
To determine, in a randomized, parallel open-label fashion, compliance rates between once-daily extended-release divalproex sodium tablets (Depakote-ER®, Abbott Labs) versus multiple-daily dose valproic acid capsules (Depakene®, Abbott Labs) in an epilepsy population.
详细描述
x_ Prospective x__ Single-center __ Multicenter x__ Open-label __ Double-blind __ Single-blind x_ Randomized (please provide randomization ratio): 1:1 This population includes both patients whose seizures are relatively well- controlled on their present conventional, enteric-coated, twice-daily or three-times daily Divalproex sodium (Depakote®, [DR]) regimen. Patients on DR monotherapy are preferred, but not required. Partial onset seizures and primarily generalized seizures will both be represented in this study. Patients will be randomized in 1:1 fashion.
Group #1: 10 patients will be randomized to IR-VPA, to be taken 3 to 4 times a day, in a total daily dose equivalent to DR. The dosing regimen will likely be taken at meal times for those receiving IR-VPA tid (not q 8 h), and additionally at bedtime for those on a QID (not q 6 h) regimen. The choice of TID vs QID regimen will be dictated by the patients' total daily dose requirements, with the attempt to keep the number of 250 mg capsules identical for each dose throughout the day.
Group #2: 10 patients will be randomized to ER, to be taken once-daily in the AM or PM at the investigator's discretion and patient's choice, since dosing ER in the AM or PM does not substantially differ as to plasma VPA concentrations [17]. Once AM or PM once-daily ER dosing is chosen for a patient, it will not be changed. ER once-daily dosing will incorporate the recommended dose-proportional increase of 8-20% in total daily dose over that of DR for patients with epilepsy (18). However, only one tablet strength (500 mg ER) will be utilized, so total daily dose will be rounded to the nearest 500 mg increment.
A total of 20 patients should provide sufficient power (80%) to adequately detect a statistically (p < 0.05) and clinically meaningful change in compliance rate between the groups, if one exists.
Compliance and precision will both be measure in this short-term study. Compliance, defined as the number of times the multiple-daily IR-VPA dose or ER dose was actually taken vs that prescribed daily, will be tallied with a computer-chip recording device (MEMS unit [13]) and via the patient's daily diary / calendar. Precision, defined as the actual time the daily dose for ER was actually taken (or multiple-daily doses for IR-VPA were actually taken) compared to the prescribed times ( + 15 min), as documented by the MEMS unit.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients, age 16 and above, currently taking Divalproex-DR for any seizure disorder; 2) Other AEDs are permitted concurrently, although compliance with these will not be recorded. Other medications for co-morbid disease are permitted, provided no plans for changes in medications used for the treatment of the concomitant disorder are expected.
- •Patients must demonstrate a 75% or greater compliance rate with DR via calendar during the week of familiarity with the MEMs unit. The threshold value of 75% has been chosen since research shows that people take approximately 75% of their AED(s) as prescribed (13,14), and the same numerical value is frequently used in determining whether or not to retain a patient in clinical Phase 2a-3b industry-sponsored study.
排除标准
- •patients with a recent history of status epilepticus; 2) patients who have refractory or unstable epilepsy; 3) patients with acute illnesses requiring changes in concurrent drugs; 4) patients unwilling to change from their present DR regimen to divalproex-ER or IR-VPA.
- •Patients unwilling or unable to utilize the MEMs monitoring unit; 6) Pregnant or lactating women.