CTRI/2009/091/000776已完成3 期
A phase III, multi-center, placebo-controlled, double blind, randomized, parallel group study to establish the efficacy of LLL-2011 administered as a 1% nasal spray in the preventive treatment of common migraine.
upin Limited (Research Park), 46A/47A, Nande village, Mulshi taluka Pune ? 411042, Maharashtra, India0 个研究点目标入组 214 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
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
入选标准
- •1. Patients with history of migraine without aura for at least 6 months prior to screening visit for study. [As per ICHD-2.1.1] (Appendix F)
- •2. Patients experience 2-6 migraine attacks* per month, but not more than 15
- •headache days# per month.
- •3. Male or female patients in the age group of 18 years to 60 years (inclusive).
- •4. Patients willing to sign Informed Consent Form.
- •Inclusion Criteria at Randomization Visit
- •1. Patients experience 2-6 migraine attacks* in placebo treatment
- •period, but not more than 15 headache days# per month.
- •* Each migraine attack should conform to criteria of International Classification of Headache Disorders, (2.1.1).
- •# Headache days: Number of days in a month patient experiences headache.
排除标准
- •1. Patients have more than 15 headache days per month or less than 2 migraine
- •attacks per month.
- •2. Patients have more than 6 attacks per year of migraine with aura.
- •3. Pregnant women or nursing mothers.
- •4. Women of child-bearing potential & all men not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 3 months after the last visit.
- •5. Patients have commenced any form of migraine prophylactic therapy within 1
- •month prior to the enrollment.
- •6. Patients need antidepressant medicines.
- •7. Patients headache attacks are associated with or attributable to an identifiable cause, such as: premenstrual period; a disease of eye, ear or nose; a neurological disease; or a psychiatric illness.
- •8. Patients are diagnosed to have nasal pathologies that may interfere with the drug absorption.
- •9. Patients with uncontrolled diabetes, uncontrolled hypertension, epilepsy or other co-existing disease for which they require a concomitant medication with anti-migraine activity, such as: β blockers, calcium channel blockers, antidepressants or antiepileptics.
- •10. Patients with history of overuse or require rescue* medication for acute migraine treatment for more than 10 treatment days per month or more than 3 days per week. *Ergots or Triptans, Antiemetics, NSAIDS & Non opiate analgesics, Opiate analgesics, Barbiturate Hypnotics, Corticosteroids, local anesthetics, Botulinum toxin or anti-migraine herbal preparations.
- •11. History of acute myocardial infarction or stroke in 6 months preceding the signing of Informed Consent Form.
- •12. History of alcohol or drug dependence.
- •13. Unlikely to maintain a diary, comply with the medication or be regular in follow-up visits.
- •14. Any serious disease that would interfere with the compliance to the study protocol.
- •15. Patients previously participated in more than 2 migraine drug trials.
- •16. Patients who have received an Investigational Drug within 4 weeks prior to screening.
- •17. Serum SGOT and SGPT > 3 X, Alkaline Phosphatase > 1.5 X, Creatinine >1.5 X and Total bilirubin > 1.5 X the upper limits of the normal (ULN) of the reference range at the screening assessment.
- •18. Patients with clinically significant renal, hepatic, cardiovascular, hemopoietic,
- •endocrinal, pulmonary, intestinal, psychiatric illness or severe mental retardation.
研究者
相似试验
进行中（未招募）
不适用
A phase III, multicenter, placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy of bevacizumab in combination with Tarceva (erlotinib) compared with Tarceva alone for treatment of advanced Non Small Cell Lung Cancer (NSCLC) after failure of standard first-Line chemotherapy - NDEUCTR2006-006626-26-ITGENENTECH , INC650
进行中（未招募）
1 期
A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination with Tarceva (erlotinib) Compared With Tarceva Alone For Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapyon-small-cell-lung-cancerMedDRA version: 9.1Level: LLTClassification code 10066490Term: Progression of non small cell lung cancerEUCTR2006-006626-26-BEGenentech, Inc.636
进行中（未招募）
不适用
A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination with Tarceva (erlotinib) Compared With Tarceva Alone For Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line ChemotherapyEUCTR2006-006626-26-DEGenentech, Inc.650
未知
3 期
Phase 3 study of SPM 962 in patients with RLS.Idiopathic Restless Legs SyndromeJPRN-jRCT2080221020Otsuka Pharmaceutical Co., Ltd.240
进行中（未招募）
1 期
A Study of Atezolizumab as Monotherapy And in Combination With Platinum-Based Chemotherapy compared to Platinum-Based Chemotherapy in Patients With Untreated Urothelial CarcinomaEUCTR2016-000250-35-EEF. Hoffmann-La Roche Ltd1,213