EUCTR2006-000156-40-ES进行中（未招募）不适用
Estudio aleatorizado, multicéntrico, doble ciego, para comparar la eficacia y seguridad de zonisamida y carbamazepina como monoterapia en pacientes con epilepsia parcial recién diagnosticada(A randomized, multi-centre, double-blind study, to compare the efficacy and safety of zonisamide and carbamazepine as monotherapy, in newly diagnosed partial epilepsy) - MAZE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 582
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.Male or female subjects, 18 to 75 years of age inclusive.
- •2.Subjects with untreated, newly diagnosed epilepsy having at least two well documented, unprovoked, clinically evaluated and classified partial seizures (with or without secondary generalization) or generalized tonic clonic seizures (without clear focal origin)within 12 months of the Screening Visit, of which at least one seizure occurred within three months of the Screening Visit (> one seizure within a 24 hour period will be counted as one seizure).
- •3.Subjects will either have had no previous use of an AED, or treatment with one AED for a maximum duration of two weeks, before the Randomization Visit (T1).
- •4.Subjects have a documented electroencephalogram (EEG) within 12 months of the Screening Visit, compatible with localization-related epilepsy (to exclude primary generalized epilepsy).
- •5.Subjects have a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the absence of a progressive neurological lesion within 12 months of the Screening Visit.
- •6.Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and randomization, must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug. Medically acceptable contraception is defined here as oral contraception pill with at least 50 micrograms ethinylestradiol per intake, contraceptive injections and implants, or intrauterine device in place for at least three months.
- •7.Subjects who are able and willing to follow investigational study procedures, maintain a seizure diary, and report AEs.
- •8.Subjects who are able and willing to give written informed consent.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects have a history of clinical investigations, including EEG data, that are suggestive of idiopathic generalised epilepsy as defined by the International League Against Epilepsy (ILAE).
- •2.Subjects with a history of absence, myoclonic, clonic, tonic, or atonic seizures.
- •3.Subjects have a history of status epilepticus, and or non-epileptic seizures (e.g. metabolic, pseudo-seizures).
- •4.Subjects have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation-related seizures.
- •5.Subjects have progressive encephalopathy or findings consistent with progressive CNS systems, disease or lesion (e.g. infection, demyelination, or tumour).
- •6.Subjects have a history of a significant or currently uncontrolled disease that will interfere with the conduct of this study or the assessment of safety and efficacy of the study drug.
- •7.Subjects have been previously treated with carbamazepine or zonisamide.
- •8.Subjects have received an investigational drug or device in the three months prior to the Screening Visit.
- •9.Subjects have a known hypersensitivity to sulfonamides, dibenzazepine derivatives, or tricyclic antidepressants.
- •10.Subjects have a history of bone marrow depression, low platelet count or other blood dyscrasia.
- •11.Subjects have a history of acute intermittent porphyria.
- •12.Subjects have a history of renal disorder (serum creatinine level of > 135 µmol / l (1.5 mg/dL) at the Screening Visit), hepatic disorder or clinically significant abnormal liver function tests; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2 times the upper normal limit.
- •13.Subjects have a body weight of less than 40 kg.
- •14.Subjects have a history of progressive malignancy within the previous 5 years (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
- •15.Subjects have a history of psychiatric illness or mood disorder requiring electro convulsive or drug therapy within the previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse; chronic treatment with benzodiazepines or barbiturates.
- •16.Subjects are currently taking carbonic anhydrase inhibitors
- •17.Subjects have a history of pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory or electro-cardiographic abnormalities, or uncontrolled hypertension.
- •18.Subjects are currently taking mono-amine oxidase inhibitors (MAOIs) or any other prohibited medications.
研究者
相似试验
进行中（未招募）
1 期
Estudio aleatorizado, multicéntrico, doble ciego, de dos ramas y controlado frente a placebo para evaluar la seguridad y la tolerabilidad, y para explorar el efecto neuroprotector de atacicept evaluado mediante tomografía de coherencia óptica (TCO) en sujetos con neuritis óptica (NO) como Síndrome Clínicamente Aislado (SCA) durante un perídod de tratamiento de 36 semanas.A two-arm, randomised, double-blind, placebo-controlled, multicenter phase II study to evaluate safety and tolerability and to explore the neuroprotective effect of atacicept as assessed by Optical Coherence Tomography (OCT) in subjects with Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) over a 36 week treatment course - Atacicept in Optic Neuritis, Phase IIeuritis ópticaOptic NeuritisMedDRA version: 9.1Level: PTClassification code 10030942Term: Optic neuritisEUCTR2007-003925-26-ESMerck Serono International S.A.82
进行中（未招募）
1 期
Estudio aleatorizado, multicéntrico, doble ciego, comparativo, exploratorio y controlado con placebo en fase II con FOLFIRI en combinación con MSC1936369B o placebo, con una safety run-in part, como segunda linea de tratamiento en pacientes con cáncer colorrectal metastásico con k-ras mutadoA double-blind, randomized, comparative, multicenter, exploratory, and placebo-controlled Phase II trial of FOLFIRI plus MSC1936369B or placebo with a safety run-in part as second-line treatment of metastatic K Ras mutated colorectal cancer subjectsCancer Colorrectal metastásico (segunda línea)MedDRA version: 12.1Level: LLTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2009-015621-36-ESMerck Serono S.A., Geneva
进行中（未招募）
不适用
Estudio aleatorizado, multicéntrico, doble ciego, en grupos paralelos, controlado con placebo y formoterol , con 4 dosis diferentes de indacaterol durante 14 días administrado a través de Twisthaler®, en pacientes adultos y adolescentes con asma persistente.A randomized, multi-center, parallel group, double-blind, placebo and formetrol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler®, in adult and adolescent patients with persistent asthmaEUCTR2007-003191-19-ESovartis Farmacéutica S.A.488
进行中（未招募）
1 期
Estudio aleatorizado, multicéntrico, doble ciego, paralelo, controlado con placebo de los efectos de JNJ-28431754 en efectos cardiovasculares en sujetos adultos con Diabetes Mellitus tipo IIA Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus - CANVASType 2 diabetes mellitus and history or high risk cardiovascular diseaseDiabetes mellitus tipo 2 e historia o riesgo elevado de efermedad cardiovascularMedDRA version: 12.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusMedDRA version: 12.0Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedEUCTR2009-012140-16-ESJanssen-Cilag International NV4,500
进行中（未招募）
1 期
Estudio aleatorizado, doble ciego, multicéntrico, de grupos paralelos, controlado con placebo y con tratamiento activo, de búsqueda de dosis del agonista Beta-3 YM-178 en pacientes con Vejiga Hiperactiva (DRAGON) - DRAGOEUCTR2005-002256-17-ESAstellas Pharma Europe B.V.1,070