CTRI/2010/091/001213未知2 期
A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules administrated orallythree times daily (TID) as Adjunctive Treatment in Patients With Partial Onset Seizures
Novartis Health care Private Limited7 个研究点 分布在 1 个国家目标入组 126 人开始时间: 待定
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 126
- 试验地点
- 7
- 主要终点
- Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
研究概览
简要总结
Target number of patients is 35.Planned FPFV from India is 23 Sep 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 65.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Male and female outpatients age 18 to 65 years (inclusive)
- •Are of greater than or equal to 50 kg (110 lb) of weight
- •Have a diagnosis of epilepsy (greater than or equal to 2 years prior to screening) with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsys Classification of Epileptic Seizures (ILAE, 1981) Appendix 5 The Diagnosis should have been established by clinical history and electroencephalogram (EEG) that is consistent with localization related epilepsy.
- •Must have had either a computed tomography (CT) or magnetic resonance imaging (MRI) within the 5 years prior to screening that ruled out progressive neurological changes (e.g. Alzheimer’s disease, Parkinson’s disease, Multiple Sclerosis); in addition, no physical examination changes suggestive of such lesions or diseases should have occurred since the imaging procedure; If a patient has not had a CT or MRI within the past 5 years, then a MRI must be performed during the screening period and the results must be reviewed for compliance with above criterion prior to randomization;
- •Must have uncontrolled partial seizures despite having been treated with at least two different anti-epileptic drugs within the last 2 years prior to screening (given concurrently or sequentially);
- •Must have at least 4 partial seizures (defined as simple partial seizures with motor signs,
- •complex partial seizures, complex partial seizures with secondary generalization or a combination of these types) during the 4-week prospective baseline period and the 4 weeks immediately preceding the baseline period (retrospective and/or prospective data)
- •Have no 28 day seizure free period during the 8 weeks preceding randomization
- •Must be receiving stable treatment (see inclusion criteria 8.1 8.4 and 9) with 1 or a maximum of 2 AEDs from the list presented below: 8.1 No change in medication type, dose or frequency for 8 weeks prior to randomization: Carbamazepine, Eslicarbazepine, Oxcarbazepine, Phenytoin, Valproate, Lacosamide, Lamotrigine, Levetiracetam, Clobazam, Topiramate, Zonisamide, Gabapentin and Pregabalin 8.2 No change in medication type, dose or frequency for 12 weeks prior to randomization: Phenobarbital and Primidone 8.3 Vagal nerve stimulation (VNS) will be counted as 1 AED 8.4 Stable benzodiazepine treatment (no change in medication type, dose, or frequency for 12 weeks prior to randomization) administered for e.g. epilepsy, anxiety, or sleep disorders will be counted as one AED Note: The use of intermittent benzodiazepines is defined in exclusion criteria 2.5 refer to Section 4.
- •If using a vagal nerve stimulator, the device must have been implanted for at least 22 weeks prior to randomization.
- •Stimulator parameters may not have been changed within 8 weeks prior to randomization
- •Also, patients having had brain surgery for partial seizures may be included, if surgery was performed greater than or equal to 1 year before randomization
- •Are on stable doses (constant for 4 weeks prior to randomization) of non-AED concomitant medication
- •Have a history of taking his or her medication(s) as directed (determined by direct questioning of patient, caregiver and or investigator knowledge of prior compliance problems if the patient had been under the investigator’s care prior to the study)
- •Are reliable and willing to make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver (parent, legal guardian) who can record and report the events for them;
- •Have provided written informed consent before any assessments are performed.
排除标准
- •Any of the following seizure conditions: 1.1 Presence of only non-motor simple partial seizures 1.2 History of psychogenic seizures 1.3 Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy 1.4 Previous history of Lennox-Gastaut syndrome 1.5 History of status epilepticus or seizure clusters (where individual seizures cannot be counted according to the judgment of the investigator) occurring within 52 weeks prior to randomization 1.6 Only seizures caused by an underlying medical illness during the 52 weeks prior to randomization
- •Have been treated with 2.1 Felbamate, unless treatment has been continuous for greater than or equal to 2 years 2.2 Vigabatrin during the 26 weeks prior to randomization 2.3 Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics such as e.g. morphine, oxycodone, fentanyl, codeine within 8 weeks prior to randomization 2.4 Barbiturates (except for seizure control) within 8 weeks prior to randomization 2.5 Intermittent benzodiazepines two or more times in a 4-week period prior to randomization (1-2 doses over a 24-hr period will be considered one-time use) 2.6 L-dopa formulations 2.7 Use of concomitant medication that are potential inhibitors of OATP transporters e.g. cyclosporine, rifampin, fluvastatine, fexofenadine 8 weeks prior to randomization Known history of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides)
- •Have had multiple drug allergies or one or more severe drug reactions to an AED, including dermatological reactions, (e.g. Stevens-Johnson syndrome, hematological, or organ toxicity reactions) a rash would not be exclusionary
- •Use of other investigational drugs within 12 weeks prior to randomization
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a negative hCG laboratory test (greater than or equal to 5mIU per mL) at screening and a negative urine test immediately prior to administering the first dose of study medication
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant including women whose partners have been sterilized by vasectomy or other means, UNLESS they are • Women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner • Using two birth control methods.
- •The two methods can be a double barrier method or a barrier method in combination with a hormonal method Adequate barrier methods of contraception include diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide.
- •Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and or a progestational agent.
- •Reliable contraception should be started at screening, maintained throughout the study and for 2 week after study drug discontinuation.
- •Women are considered post menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels greater than 40 mIU per mL [for US only: and estradiol less than 20 pg per mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.
- •In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- •Any of the following cardiovascular conditions 8.1 Myocardial infarction and or cerebrovascular accident (CVA or stroke) within 26 weeks prior to screening 8.2 History of or unstable angina pectoris at Screening or Baseline 8.3 Hypertension uncontrolled by medication (defined as supine systolic blood pressure greater than or equal to 160 mmHg, or diastolic blood pressure greater than or equal to 100 mmHg) at screening or baseline or if re-assessed as abnormal according to the above stated limits at prior to initial dosing on Day 1.
结局指标
主要结局
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
时间窗: 28 days
次要结局
- 1) Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.(28 days)
研究者
研究点 (7)
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