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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:
Information provided by:
elbion AG
ClinicalTrials.gov Identifier:
NCT00322803
First received: May 5, 2006
Last updated: September 27, 2006
Last verified: September 2006
History of Changes

May 5, 2006
September 27, 2006
May 2006
Not Provided
  • 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)
Same as current
Complete list of historical versions of study NCT00322803 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Panic Disorder
Drug: ELB139
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
October 2006
Not Provided

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands
 
NCT00322803
ELB139202-05, EudraCT Number:2005-005708-17
Not Provided
Not Provided
Not Provided
Not Provided
elbion AG
Not Provided
Principal Investigator: Eric Griez, Prof Dr Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University
elbion AG
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP