EUCTR2010-019035-35-BG进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN CONTROLLED RELEASE FORMULATION AS ADJUNCTIVE THERAPY IN ADULTS WITH PARTIAL ONSET SEIZURES - PROTOCOL A0081194
Pfizer Inc. 235 East 42nd Street, New York, NY 100170 个研究点目标入组 333 人开始时间: 2011年2月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 333
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of and agrees to all pertinent aspects of the study. 2.Otherwise healthy men or non-pregnant, non-lactating women aged 18 years or older. Men and women must use an acceptable method of contraception as detailed in the lifestyle guidelines section. Women must have a confirmed negative pregnancy test prior to enrollment. 3.Diagnosis of epilepsy with partial onset seizures (as defined in the International League Against Epilepsy Classification of Seizures 1997, 2010, Appendix 3). Partial onset seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure (previously termed secondary generalization). In addition to this, for determination of eligibility the following definitions cross from the ILAE of 1997 to those of 2010. Seizures without impairment of consciousness or awareness must have an observable motor component and are termed simple partial seizures. When there is impairment in consciousness or awareness, the 1997 term complex partial seizures is applied. Diagnosis must be established by subject’s history (eg, the phenomenology (description) of the seizures, excluding confounding disorders such as pseudo-seizures, syncopes, etc.), family history, neurological examination, the results of EEG testing done within 2 years prior to study participation and the results of brain imaging (if none available, must be obtained during the 8 week screening
- •pre-randomization period and be available at V3). Results must be consistent with
- •the diagnosis of focal-onset epilepsy. Simple partial seizures without a visible motor
- •component (ie, lacking visible movements during the seizure) are not counted toward
- •eligibility. 4.Subjects must have a minimum of 3 partial seizures during the 1 month (28 days) prior to the screening visit for entry into baseline observation phase and at least 6 partial seizures during the 8 week baseline observation phase with no 28 day period free of partial seizures. A caregiver or witness must be with the Subject for a sufficient duration to accurately chronicle the occurrence of seizures, if appropriate given the subject's seizure types. These seizures must be documented properly in the subject's seizure diary. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) will be recorded, but are not counted toward eligibility. 5.Subjects who currently take 1 to 3 AEDs that are at stable dosages, within clinically acceptable therapeutic range or within the range of tolerability of the subject, and who have taken at least 2 prior (or ongoing) AEDs. For two weeks prior to screening and during study participation subjects must remain on stable dosages (same dosage throughout the study: at screening, the baseline observation period, and the double blind maintenance period) of 1 to 3 AEDs concomitantly throughout the trial. Other AEDs must be discontinued completely at least 2 weeks prior to screening (this does not include rescue medication). 6.No progressive structural abnormality on a head CT scan (with contrast) or MRI within 2 years prior to study participation (if none available, must be obtained and evaluated prior to randomization). 7.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. S
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1.A progressive cause of seizures or a reversible cause of seizures 2.Subjects who only experience simple partial seizures without a motor component in the 8 week baseline seizure record phase. 3.Primary generalized seizures (including in setting of co-existing partial-onset epilepsy), which include for example: Clonic, tonic & tonic clonic seizures (secondarily generalized seizures are permitted); Absence seizures; Myoclonic, Myoclonic atonic, Myoclonic tonic seizures; Reflex epilepsies. 4.Lennox Gastaut Syndrome. 5.Status epilepticus within 1 year prior to screening. 6.Subjects with other neurologic illness that could impair endpoint assessment. 7.A significant psychiatric disorder, recurrent episodes of severe depression (any pharmacologic treatment or hospitalization for illness within 1 year prior to Screening) or subjects with serious suicidal risk. Subjects with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of single antidepressant are acceptable. 8.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality (including, for example, platelet count <100 x 10 to the power of 9/L; white blood cell (WBC) count <2.5 x 10 to the power of 9/L; neutrophil count <1.5 x 10 to the power of 9/L) that may increase risk associated with study participation or investigational product administration or may interfere with interpretation of study results and, in the judgment of investigator, would make the subject inappropriate for entry into this study.9.Subjects with any clinically unstable medical conditions including: cardiovascular, hematological, autoimmune, endocrine, renal, hepatic, retinal & gastrointestinal disease. 10.Any subjects who are considered at risk of suicide based on Sheehan Suicidality Tracking Scale or PHQ 8 or likely to self harm, based on clinical judgment. Based on judgment of the investigator, a subject should be excluded or a risk assessment should be done by a qualified mental health professional if the subject has had suicidal ideation in past 6 months, suicidal behaviors or attempts in the past year, or current major psychiatric disorders that are not explicitly permitted in inclusion/exclusion criteria. 11.Screening 12 lead ECG with clinically significant abnormalities prior to andomization.12.Subjects with a history of life-threatening neoplasms within 5 years prior to study entry, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin. 13.Subjects with active gastrointestinal (GI) disease including any GI surgery that in the opinion of the investigator or Sponsor would interfere with absorption of study medication. 14.Subjects with difficulties swallowing tablets or unable to tolerate oral medication.
- •15.Estimated creatinine clearance (CLcr) <60 mL/min (using Cockcroft Gault equation).Subjects who have estimated CLcr <60 mL/min by this screening method may have their CLcr measured, at investigator’s discretion, with a 24 hour urine collection performed at the central laboratory. If this 24 hour urine CLcr is >60 mL/min, the subject is not excluded. 16.Alcohol or substance abuse or dependence within the previous year. 17.Use of prohibited medications as listed in protocol in absence of an washout phase, or likelihood of requiring treatment during study period with medications not permitted by the protocol.18.Subjects who are n
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