EUCTR2012-003729-62-GB进行中（未招募）1 期
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of R-Verapamil in the Prophylaxis of Episodic Cluster Headache - R-Verapamil in the Prophylaxis of Episodic Cluster Headache V.1
CENTER LABORATORIES, INC0 个研究点目标入组 30 人开始时间: 2012年10月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •Participants will be healthy men and women between the ages of 18 and 65
- •Participants in good health as determined by medical history and medical examination including vital signs and ECG. Serum biochemistry and hematology need to be normal
- •Participants with a diagnosis of episodic cluster headache as defined by the International Classification of Headache Disorders (2nd edition)
- •Participants must have a lifetime prevalence of at least 2 prior cluster bouts
- •Participants must experience at least 7 attacks/week during the run-in baseline period
- •Participants must have a typical cluster period lasting at least 1 month. Subjects must present in active cluster period and the expected remaining duration of the cluster bout must be at least 3 weeks from Baseline Day 1 visit
- •Participants with other headache types are eligible provided the subject is able to differentiate these headaches from cluster headaches
- •Participants are using or agree to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
- •Participants have a negative urine pregnancy test prior to study entry, if female of child-bearing potential
- •Participants is able to understand and comply with all study requirements
- •Participants provides written informed consent prior to any screening procedures being conducted
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Women who are pregnant or lactating
- •Participants who, in the investigators opinion, have a history of or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
- •Participants using any drug or having any medical condition which might interact adversely with, or interfere with the action of, the study medication
- •Participants who are allergic to or have shown hypersensitivity to verapamil or agents similar to verapamil
- •Participants who abuse opioids or have a history of significant drug or alcohol abuse within the past year as determined by investigator
- •Participants who have participated in an investigational drug trial in the 30 days prior to the screening visit
- •Participants with liver or kidney disease
- •Participants with cardiopathology contraindicating verapamil administration (second or third grade atrioventricular block, sinoatrial block, sinus node syndrome, heart rate <50/minute, or systolic blood pressure <90 mm Hg)
- •Participants with previous adynamic ileus
- •Participants with chronic cluster headache
- •Use of antipsychotic, antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion
研究者
相似试验
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBERCystic FibrosisFibrosis quísticaMedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lungEUCTR2008-004699-34-ESAstraZeneca AB50
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel-group, Multicentre, 24 week Study to Evaluate the Efficacy and Safety of Transdermal Testosterone (300 mcg/day) in Naturally Menopausal Women with Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen, Oral Non-Conjugated Equine Estrogen, or No Estrogen Therapy - ADOREHypoactive sexual desire disorderEUCTR2006-001179-39-DEProcter & Gamble Pharmaceuticals270
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Long Term (one year) Efficacy and Safety Study of Tiotropium Inhalation Solution 5µg (2 puffs of 2.5µg) Delivered by the Respimat Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD)EUCTR2006-001009-27-HUBoehringer Ingelheim Pharma GesmbH3,000
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod (GW856553) Tablets Administered Twice Daily compared with Placebo for 24 Weeks in Adult Subjects with Chronic Obstructive Pulmonary Disease (COPD).EUCTR2010-019695-76-EEGlaxoSmithKline Research & Development675
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre, Long-Term Study to Evaluate the Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 52 Weeks in Adult and Adolescent Subjects with Perennial Allergic RhinitisPerennial allergic rhinitisEUCTR2004-000091-14-LTGlaxoSmithKline736