EUCTR2011-004156-19-GB进行中（未招募）不适用
A Phase 2b, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of VX-765 in Subjects With Treatment Resistant Partial Epilepsy With a 24-Week Open-Label Extension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •Males or females aged 18 to 64 (inclusive) years with a BMI between
- •18 and 35 (kg/m2)
- •Subjects who have completed the assigned study treatment in Part A
- •may enter Part B if eligible per protocol
- •Subjects must agree to use acceptable contraceptive methods as
- •described in Section 12.7.5. of the study protocol
- •Must have a diagnosis and hx of treatment-resistant partial-onset
- •epilepsy (as defined in protocol) and are taking 1 to 4 stable doses of
- •concomitant AEDs at the time of Screening Period
- •Subjects must have had at least 1 EEG consistent with partial epilepsy
- •Must have had at least 6 partial-onset seizures and a seizure free
- •period of no more than 3 weeks during Baseline
- •Subjects with stable medical conditions as determiend by Principal
- •investigator
- •Must understand and comply with the protocol requirements and be
- •willing to provide written informed consent to participate
- •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 500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who are pregnant or lactating or do not agree to use medically approved methods of contraception as outlined in the protocol - for the duration of the study and for 90 days after last dose of study
- •Subjects who are male and have a female partner who is pregnant,
- •nursing, or is planning to become pregnant during the study period, or
- •within 90 days of the last dose of study drug
- •Subjects with a history of nonepileptic, transient alterations in
- •consciousness (e.g., metabolic, structural, and post traumatic or pseudo
- •Those who have a history of status epilepticus in the past 12 months
- •before the Screening Visit
- •Subjects whose seizure frequency cannot be quantified
- •Subjects who have a significant medical illness including kidney, liver,
- •pulmonary, or gastrointestinal disease; or unstable or poorly controlled
- •conditions such as hypertension, diabetes, or angina pectoris, as judged
- •by the investigator
- •Subjects with clinically significant psychiatric illness or had an active
- •suicidal plan/intent, thoughts, or attempt as defined in the study
- •Subjects with clinically significant laboratory abnormalities during the
- •Screening Visit/Baseline Period, as judged by the investigator
- •Subjects who have had serious adverse events (SAEs) thought to be
- •related to study drug that led to discontinuation during Part A may not
- •participcate in Part B
- •Subjects with active hepatitis B, hepatitis C, or human
- •immunodeficiency virus (HIV)
- •Subjects with positive drug screen at screening or during the Baseline
- •Period (excluding any allowed prescribed medications) and/or a history
- •of alcoholism or drug addiction within past 2 years
- •Subjects on felbamate with fewer than 18 month of continuous
- •felbamate exposure at the time of the Screening Visit or with significant
- •adverse reactions to felbamate
- •Subjects treated with vigabatrin fewer than 2 years prior to the
- •Screening Visit or who have a prior history of treatment with vigabatrin
- •without a documented stable examination by an ophthalmologist or
- •neuroophthalmologist of the visual field within the 2 years prior to the
- •Screening Visit
- •Subjects using prohibited medications (Section 10.3 and Table 10 1) or
- •treated with any systemic immunosuppressant as defined in the protocol
- •Subjects who experienced a symptomatic viral, fungal, or bacterial
- •infection requiring systemic treatment within 7 days prior to the first
- •dose of study drug
- •Subjects with a current or prior history of illness precluding them from
- •immunomodulatory therapy
- •Subjects who have donated any blood or have had a significant loss of
- •blood (500 mL) as defined in the protocol
- •Subjects who participated in any other clinical studies involving an
- •investigational product or device and have received the last dose of the
- •study drug associated with that clinical study within 30 days or 5 half
- •lives (whichever is longer) of the Screening Visit
- •Subjects who have participated in earlier VX-765 clinical studies and
- •received at least one dose of study drug
- •Subjects who have no completed the full 13-week Treatment Period in
- •part A may not participate in Part B
- 另有 2 项未显示
研究者
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