ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00322803
• Other study ID #: ELB139202-05
• Secondary ID: EudraCT Number:2
• Status: Terminated
• Phase: Phase 2
• First received: May 5, 2006
• Last updated: September 27, 2006
• Start date: May 2006
• Est. completion date: October 2006

Study information

• Verified date: September 2006
• Source: elbion AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of concurrent panic disorder

• At least 2 panic attacks within the 4 weeks before the screening visit

• Naïve to the CO2 challenge test

• Age 18–65 years (inclusive)

• Ability to comply with all procedures mandated by the study protocol

• Negative pregnancy test and adequate contraceptive measures

Exclusion Criteria:

• History of poly-pharmacotherapy for panic disorder or treatment resistance

• Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia

• History of abuse of benzodiazepines or tolerance to effects of benzodiazepine

• Any concomitant psychotropic medication

• Evidence of impaired hepatic, renal or cardiac functions

• Participation in any drug trial in the preceding 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Drug:
• ELB139

Locations

Country	Name	City	State
Germany	Charité – University Clinics Berlin	Berlin
Germany	Emovis, The institute of emotional health	Berlin
Netherlands	Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
elbion AG

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)
Primary	difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta)
Secondary	Total Symptom Score assessed immediately after CO2 challenge (TSS-post)
Secondary	Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)