CTRI/2019/12/022452尚未招募1 期
A Multicentric, Open-label, Randomized, Two Treatment, Two Sequence, Two Period, Cross Over, Steady state Clinical Bioequivalence Study of Vigabatrin Tablets USP 500 mg of Aurobindo Pharma Limited, India (Test) With SABRIL(Vigabatrin) Tablets 500mg of Lundbeck Pharmaceuticals LLC, USA (Reference) in adult refractory complex partial-seizure patientâ??s who are already on established Vigabatrin adjunctive therapy under Fasting conditions.
APL Research CenterII0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Adult patients with refractory complex partial-seizure who are already on established vigabatrin adjunctive therapy with a dose of 500 mg twice daily for at least one month prior to Day 0 of the study.
- •2.Male or female patients of 18 to 55 years of age.
- •3.The patient has refractory Complex Partial Seizure as evidenced by the attainment of all the following criteria:
- •a.The patient has failed because of lack of efficacy with 2 or more anti-epileptic drugs (AEDs) of differing pharmacologic mechanisms administered as monotherapy or polytherapy
- •b.The patient should be taking at least 1 AED (A vagal nerve stimulator is not counted as an AED)
- •4.Patients with clinically non-significant findings on ophthalmologic assessments for visual field and visual acuity at screening.
- •5.Patients with adequate hematopoeitic and liver function at screening, defined as:
- •a)Hemoglobin of >= 9.0 g/dL
- •b)ANC >= 1500/mm3, Platelet count >= 100,000/mm3
- •c)AST and ALT <= 3 times ULN, Alkaline phosphatase <= 2.5 times ULN, Bilirubin <= 1.5 times ULN
- •6.Patient or his/her Legally Acceptable Representative had given consent after being advised of the nature and risks of the study.
- •7.Female patient of childbearing potential must have a negative serum pregnancy test at screening.
- •8.Women of childbearing potential must agree to use adequate contraception prior to study entry, and for 60 days following completion of therapy.
- •9.Females must use acceptable and effective methods of contraception such as the following:
- •a)Tubal sterilization (tubal ligation performed more than one month before Study Day 1; transcervical tubal occlusion procedure performed more than six months before Study Day 1) or
- •b)Intrauterine Device (IUD) or
- •c)Progestin Implant (i.e. Implanon or its equivalent) or
- •d)Progestin injection or progestin oral contraceptive pill + one barrier method (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom) or
- •e)Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom) or
- •f)Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner)
- •10.Male subjects agreed to use contraceptive methods prior to study entry, and for 60 days following completion of study.
排除标准
- •1.Pre-existing ocular or neurological disease that might affect bilateral visual fields or interfere with perimetry (e.g.aphakia, visually significant cataract, glaucoma, diabetes mellitus, ischemic optic neuropathy, multiple sclerosis).
- •2.Concurrent exposure to medications with known or suspected retinal or optic nerve toxicity.
- •3.Use of drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma
- •4.Concurrent use of the ketogenic or similar diet.
- •5.Patient on vagal nerve stimulator as a monotherapy
- •6.For any reason, the patient is considered by the investigator to be an unsuitable candidate for the study.
- •7.Anemic patients
- •8.Patients with history of allergic reactions to vigabatrin
- •9.Patients with emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
- •10.Patient had received any investigational drug within the past 90 days.
- •11.Patient had history of difficulty with donating blood or difficulty in accessibility of veins
- •12.Patients with Peripheral Neuropathy
- •13.Patient who are pregnant or nursing females.
研究者
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