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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322803
First Posted: May 8, 2006
Last Update Posted: September 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
elbion AG
  Purpose
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.

Condition Intervention Phase
Panic Disorder Drug: ELB139 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by elbion AG:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)

Estimated Enrollment: 24
Study Start Date: May 2006
Estimated Study Completion Date: October 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322803


Locations
Germany
Charité – University Clinics Berlin
Berlin, Germany, 10117
Emovis, The institute of emotional health
Berlin, Germany, 10629
Netherlands
Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
elbion AG
Investigators
Principal Investigator: Eric Griez, Prof Dr Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
  More Information

ClinicalTrials.gov Identifier: NCT00322803     History of Changes
Other Study ID Numbers: ELB139202-05
EudraCT Number:2005-005708-17
First Submitted: May 5, 2006
First Posted: May 8, 2006
Last Update Posted: September 29, 2006
Last Verified: September 2006

Keywords provided by elbion AG:
panic disorder
proof of concept

Additional relevant MeSH terms:
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
1-(4-chlorophenyl)-4-piperidin-1-yl-1,5-dihydroimidazol-2-one
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action