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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00322803

Enrollment

Registered

2006-05-08

Start date

2006-05-31

Completion date

2006-10-31

Last updated

2006-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panic Disorder

Keywords

panic disorder, proof of concept

Brief 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.

Interventions

DRUGELB139

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)	—
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

Measure	Time frame
Total Symptom Score assessed immediately after CO2 challenge (TSS-post)	—
Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)	—

Countries

Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026