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

• Conditions: Male and female patients with 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 with at least 2 panic attacks in the last 4 weeks before screening; Classification code 10037175

• Registration Number: EUCTR2005-005708-17-DE
• Lead Sponsor: elbion AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified