EUCTR2005-005708-17-DE进行中（未招募）不适用
International, multicenter, randomized, double-blind, placebo controlled, two-period, cross-over study to demonstrate safety, tolerability and anxiolytic effects of 600 mg ELB139 given orally t.i.d. to patients with concurrent panic disorder, challenged by inhalation of 35% CO2 after a single dose and one week of treatment - ELB139 Proof of concept study in panic disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- elbion AG
- 入组人数
- 24
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.Diagnosis of concurrent panic disorder according to DSM-IV, with or without agoraphobia (DSM IV 300.21 and 300.1) according to Mini International Neuropsychiatric Interview (MINI); structured diagnostic psychiatric interview for DSM-IV.
- •2. At least 2 panic attacks within the 4 weeks before the screening visit.
- •3. Naïve to the CO2 challenge test.
- •4. Age 18–65 years (inclusive).
- •5. Ability to comply with all procedures mandated by the study protocol.
- •6. Written informed consent to participate in study.
- •7. Negative pregnancy test and agreement to use a highly effective method of birth control for at least three months prior to inclusion in this study and not nursing, if female and with childbearing potential.
- •Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomises partner.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of poly-pharmacotherapy for panic disorder* or treatment resistance**.
- •(* More than two different types of psychotropic treatments or two medications given concomitantly against panic disorder)
- •(** No response to two well conducted i.e. with a sufficient dose for a sufficient time treatments).
- •2. Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia.
- •3. Patients in stable remission of panic disorder, i.e. well contralled clinical conditions
- •4. History of abuse (according to DSM-IV criteria) of benzodiazepines or tolerance to effects of benzodiazepine.
- •5. Any concomitant psychotropic medication (for wash out periods, see Section 7.5)
- •6. Known hypersensitivity to any of the drug substances or excipients of the study medication.
- •7. Evidence of impaired hepatic (alanin aminotransferase > 3 x upper limit of normal range, gamma glutamyl transferase > 3 x upper limit of normal range, cholinesterase 0,75 x below lower limit of normal range ) or renal function (serum creatinine > 2 x upper limit of normal range).
- •8. History or evidence of relevant cardiovascular or cerebrovascular disorders such as angina pectoris, cardiac infarction, cardiomyopathy, cardiac failure, cardiac arrhythmias, TIAs, cerebrovascular accidents.
- •9. ECG signs of prolonged cardiac repolarization (QTc value [Bazett's correction] > 450 msec).
- •10. Need of concomitant medication with torsadogenic potential (lists 1 and 2 on the web site www.torsades.org) and Appendix 4 of study protocol)
- •11. Arterial hypertension with systolic pressure > 180 mmHg or diastolic pressure > 100 mm despite therapy.
- •12. History or family history of cerebral aneurysm.
- •13. History of epilepsy or recurrent seizures.
- •14. History or evidence of clinically relevant respiratory diseases such as asthma, COPD, lung fibrosis.
- •15. Family history of sudden unexpected death and/or arrhytmias in family members of age < 45 or presence of familial long QT-syndrome.
- •16. Heavy smoker (> 15 cigarettes/day).
- •17. Participation in any drug trial in the preceding 6 months.
研究者
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