NCT00195806已完成3 期
Divalproex Sodium Extended-Release Tablets for Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Number of migraine headache days
研究概览
简要总结
The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed;
- •Subject is male, or a non-pregnant, non-lactating female;
- •Subject is between 12 and 17 years of age, inclusive, at the Screening Visit;
- •Subject weighs at least 77 lbs. (i.e., 35 kg);
- •Subject currently has diagnosis of migraine headaches consistent with International Headache Society (IHS) criteria;
- •Subject is judged to be in generally good health based on the results of a medical history, physical examination, 12-lead electrocardiogram (ECG), and laboratory profile; and
- •In the investigator's opinion, the subject will benefit from Depakote ER for migraine prophylaxis.
排除标准
- •History of allergic reaction or significant sensitivity to valproate or similar drugs;
- •History of noncompliance with medication or medical instructions;
- •Recent (previous 6 months) history of drug and/or alcohol abuse or has a positive urine drug screen, at the Screening Visit, for drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and phencyclidine [PCP]);
- •Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives) as judged by the investigator.
- •Use of the following medication classes or any specific drug listed below:
- •anti-depressants, other antiepileptic drugs (AEDs)
- •aspirin and/or aspirin-containing products
- •chronic use of systemic corticosteroids, clonazepam,diazepam, erythromycin, ethosuximide, pemoline, phenobarbital,rifampin,tolbutamide, zidovudine
- •anticoagulant drug therapy;
- •Any serious medical or psychiatric disorder(s), including epilepsy and obesity, that may confound the interpretation of the results from this study;
- •Central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease;
- •History of encephalopathy, hepatitis, pancreatitis, or urea-cycle disorder or any underlying condition/disease, which might interfere with study drug absorption or completion of study drug therapy evaluation throughout the duration of the trial;
- •Screening laboratory results indicate the presence of Hepatitis B surface antigen (HBsAg), or Hepatitis C antibody or known history of any positive test result for HIV;
- •Screening laboratory results indicate:
- •Platelet count =/< 100,000/uL
- •ALT or AST =/> 2 times Upper Limit of Normal (ULN);
- •Receipt of an investigational drug within 30 days prior to study drug administration or scheduled to receive any other investigational drug anytime during the study;
- •Participation in a prior Depakote ER migraine study (M02-488 or M02-554); or if for any reason, subject is considered by the investigator to be an unsuitable candidate to receive Depakote or to participate in this study.
结局指标
主要结局
Number of migraine headache days
次要结局
- Adverse events
- Laboratory data
- Vital signs
- Study drug exposure
- Behavioral/cognitive assessments
研究者
研究点 (2)
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