EUCTR2008-003333-25-BG进行中（未招募）不适用
Multicenter, Double-Blind, Randomized, Placebo-Controlled, Three-Arm,Parallel Group Study to Evaluate the Efficacy and Safety of OxcarbazepineExtended-Release (OXC XR) (1200 and 2400mg/day) as AdjunctiveTherapy in Subjects with Refractory Partial Seizures due to Epilepsy on upto Three Concomitant Antiepileptic Medications - PROSPER
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
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) Capable of complying with the study procedures.
- •2) Able to provide written informed consent prior to any study procedure being conducted.
- •3) Male or female aged 18 to 65 years, inclusive.
- •4) Current diagnosis of partial onset seizures with or without secondarily generalized seizures as
- •confirmed by the 1981 and 1989 International League Against Epilepsy [ILAE] Classifications.
- •5) Experiencing at least three countable partial seizures per 28 days on average during the eightweek
- •Baseline Phase, or during the four-week Baseline plus the four-week period prior to
- •Baseline, assuming the recording method is considered acceptable. Simple partial seizures in the
- •Baseline Phase must have had an observable motor component.
- •6) Currently receiving treatment with at least one and up to three AEDs with AED therapy remaining
- •at a stable dose for at least four weeks prior to Baseline (equivalent to 12 weeks prior to
- •randomization). A vagal nerve stimulator (VNS) will be allowed, but will not be considered as one
- •of the concomitant AEDs for the purpose of inclusion into the study. The VNS must have been
- •implanted for at least six months prior to randomization. Stimulator parameters may not be
- •changed for at least one month prior to screening (equivalent to 12 weeks prior to randomization)
- •or during the study. Note, magnet use will be allowed, but must be documented throughout the
- •7) History of being refractory on at least one and up to three AEDs in single or combination use.
- •8) Magnetic resonance imaging (MRI), with or without contrast, or computerized tomography (CT),
- •within the past 5 years showing no progressive neurological conditions. For subjects with MRI or
- •CT older than 5 years, the MRI or CT can be performed in screening.
- •9) Use of prescription medications, except those specifically prohibited by protocol, and over-thecounter
- •products, including natural food supplements, vitamins, garlic as a supplement, will be
- •permitted as long as a stable dose has been maintained for four weeks prior to receiving study
- •medication (SM).
- •10) Weight = 41kg.
- •11) Sexually active women, unless surgically sterile (at least 6 months prior to SM administration) or
- •at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including
- •oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a
- •secondary method], intrauterine device, female condom with spermicide, diaphragm with
- •spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile
- •[at least 6 months prior to SM administration] sexual partner) for at least four weeks prior to SM
- •administration, and must agree to continue using such precautions through the End of Study visit.
- •Cessation of birth control after this point should be discussed with a responsible physician.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) History of being refractory to OXC for reasons of efficacy based on 1200mg/day dose and
- •2-month trial period.
- •2) A documented history of generalized status epilepticus within the past 2 years.
- •3) A documented history of non-epileptic seizures in the past 2 years.
- •4) Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease,
- •degenerative neurological disease, or central nervous system disease deemed progressive,
- •metabolic illness, or progressive degenerative disease.
- •5) Diagnosis or an encephalogram consistent with a diagnosis of seizure disorders other than partial
- •6) Meets criteria for current major depressive episode, according to Diagnostic and Statistical
- •Manual of Mental Disorders, Fourth Edition Text Revision, within 6 months prior to
- •Screening (Visit 1).
- •7) Current use of antidepressants. However, those subjects who are only taking a stable dose of
- •either a selective serotonin reuptake inhibitor (SSRI) antidepressant drug or a serotonin and
- •norepinephrine reuptake inhibitor (SNRI) antidepressant drug for a diagnosed depressive disorder
- •can be included as long as they have been on the SSRI or SNRI for a period of at least 56 days
- •prior to randomization. Other antidepressant medications will not be allowed.
- •8) Active suicidal plan/intent or active suicidal thoughts in the past 6 month.
- •9) Suicide attempt within the last 2 years;
- •10) More than one lifetime suicide attempt.
- •11) History or presence of clinically significant, chronic medical condition, including hyponatremia,
- •especially those contraindicating antiseizure medication (e.g., any neurological, gastrointestinal,
- •endocrine, cardiovascular, pulmonary, hematological, immunologic, renal, hepatic, or metabolic
- •disease) that may affect the safety of the subject in the opinion of the Investigator.
- •12) Current use of oxcarbazepine.
- •13) Phenytoin use is allowed if the subject is on a stable dose and the results of two consecutive
- •serum phenytoin levels are <15 mcg/mL. One of the two levels must be drawn at screening.
- •14) Use of felbamate with less than 18 months of continuous exposure prior to screening.
- •15) Frequent need of rescue benzodiazepines (more than once in a 7 day period).
- •16) Current use of diuretics or other sodium (Na+) lowering non-anti-epileptic medications.
- •17) History or presence of clinically significant laboratory, electrocardiogram (ECG), or vital sign
- •(systolic blood pressure [SBP] <90 or >140 millimeters of mercury [mmHg], diastolic blood
- •pressure [DBP] <40 or >90mmHg, or heart rate [HR] <40 or >100 beats per minute [BPM])
- •abnormalities at screening that may affect the safety of the subject, in the opinion of the
- •Investigator.
- •18) Presence of potential hepatic function impairment as shown by, but not limited to alanine
- •aminotransferase (ALT) and aspartate aminotransferase (AST) values >3 times upper limit of
- •normal (ULN), or total bilirubin >1.5 ULN.
- •19) Presence of suspected impairment of renal function defined by serum creatinine =1.5 times ULN.
- •20) History of alcohol abuse within two years prior to the screening.
- •21) History of substance abuse or dependence within two years prior to screening.
- •22) Females who are pregnant or lactating.
- •23) Previous known hypersensitivity to OXC or other related drugs, such as carbamazepine, or any of
- •the product components.
- •24) Use of an investigational drug or device, or participation in an investigational study within 30 days
- •prior to the first dose of SM.
- •25) Difficulty s
研究者
相似试验
已完成
3 期
Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis10014982Plaque PsoriasisNL-OMON45268Eli Lilly4
进行中（未招募）
1 期
A Study of Gantenerumab in Patients With Prodromal Alzheimer's DiseaseProdromal Alzheimer’s DiseaseMedDRA version: 17.0Level: LLTClassification code 10066571Term: Progression of Alzheimer's diseaseSystem Organ Class: 100000004852EUCTR2010-019895-66-CZF. Hoffmann-La Roche Ltd797
已完成
2 期
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease with option for an additional two years of treatment10011305Alzheimer's diseasedementiaNL-OMON39809Roche Nederland B.V.48
已完成
3 期
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (FASLODEX) with or without PD-0332991 (PALBOCICLIB) ± Goserelin in Women with Hormone Receptor-Positive, Her2-Negative Metastatic Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy10006291breast cancerNL-OMON50735Pfizer35
进行中（未招募）
1 期
A Study of Gantenerumab in Patients With Prodromal Alzheimer's DiseaseProdromal Alzheimer’s DiseaseMedDRA version: 20.0Level: LLTClassification code 10066571Term: Progression of Alzheimer's diseaseSystem Organ Class: 100000004852EUCTR2010-019895-66-DKF. Hoffmann-La Roche Ltd797