PER-121-06已完成未知
ANTIPARASITIC THERAPY FOR NEUROCYSTICERCOSIS: PHASE II / III STUDY ON SAFETY AND EFFECTIVENESS AND COMBINED TREATMENT OF PRAZICUANTEL AND ALBENDAZOLE
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,0 个研究点目标入组 124 人开始时间: 2007年1月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Men and women between 16 and 65 years of age, with a diagnosis of viable cerebral parenchymal cysticercosis with 20 or fewer viable cysts detected by MRI and CT, and confirmed by Western Blot serology.
- •2. Patients with a diagnosis of epilepsy secondary to NCC and a history of one or more spontaneous seizures in the previous year and no more than 10 years.
- •3. Willingness to complete the minimum of two weeks of hospitalization required.
- •4. If the patient is a woman of childbearing age, negative urine tests and the willingness to use an adequate contraceptive method.
- •5. Normal values of hemoglobin, platelet count, white cell count, glucose and normal or decreased values of GOT, TGP, creatinine.
- •6. Negative PPD and, if positive, sputum results for TB, negative.
- •7. Negative stool test for Taenia eggs or Strongyloides larvae.
排除标准
- •1. Generalized Primary Epilepsy.
- •2. History of generalized epileptic status.
- •3. Type of NCC that exposes the patient to greater risks during the study.
- •4. Patients with persistent or progressive endocranial hypertension (HTE) or intracranial hypertension defined radiologically by CT or MRI.
- •5. Previous therapy with ABZ or PZQ in the last two years.
- •6. Pulmonary tuberculosis evidenced by chest x-ray and positive results of sputum, or signs compatible with tuberculosis infection.
- •7. Individuals with positive markers for active hepatitis.
- •8. Systemic disease distinct from NCC that may affect treatment or short-term prognosis.
- •9. Patients with unstable condition.
- •10. Pregnancy during the antiparasitic treatment.
- •11. History of hypersensitivity to ABZ or PZQ.
- •12. Simultaneous treatment with cimetidine or theophylline.
- •13. Chronic alcohol or drug abuse.
- •14. Inability or non-availability to perform a CT scan at the beginning of the study or an MRI at the sixth month.
- •15. Inability or non-availability of the subject or agent / legal representative in giving written informed consent.
研究者
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