Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT00322803
Status:
TERMINATED
Last Update Posted:
2006-09-29
First Post:
2006-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016584', 'term': 'Panic Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C504151', 'term': '1-(4-chlorophenyl)-4-piperidin-1-yl-1,5-dihydroimidazol-2-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2006-10'}, 'lastUpdateSubmitDate': '2006-09-27', 'studyFirstSubmitDate': '2006-05-05', 'studyFirstSubmitQcDate': '2006-05-05', 'lastUpdatePostDateStruct': {'date': '2006-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)'}, {'measure': '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)'}], 'secondaryOutcomes': [{'measure': 'Total Symptom Score assessed immediately after CO2 challenge (TSS-post)'}, {'measure': 'Difference of the Total Symptoms Score (TSS) measured as the difference between the pre- and post challenge scores (TSS-delta)'}]}, 'conditionsModule': {'keywords': ['panic disorder', 'proof of concept'], 'conditions': ['Panic Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of concurrent panic disorder\n* At least 2 panic attacks within the 4 weeks before the screening visit\n* Naïve to the CO2 challenge test\n* Age 18-65 years (inclusive)\n* Ability to comply with all procedures mandated by the study protocol\n* Negative pregnancy test and adequate contraceptive measures\n\nExclusion Criteria:\n\n* History of poly-pharmacotherapy for panic disorder or treatment resistance\n* Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia\n* History of abuse of benzodiazepines or tolerance to effects of benzodiazepine\n* Any concomitant psychotropic medication\n* Evidence of impaired hepatic, renal or cardiac functions\n* Participation in any drug trial in the preceding 6 months'}, 'identificationModule': {'nctId': 'NCT00322803', 'briefTitle': 'ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'elbion AG'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ELB139202-05'}, 'secondaryIdInfos': [{'id': 'EudraCT Number:2005-005708-17'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ELB139', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - University Clinics Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10629', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Emovis, The institute of emotional health', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '6200 MD', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Eric Griez, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academic Anxiety Center and Department of Psychiatry & Neuropsychology; Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'elbion AG', 'class': 'INDUSTRY'}}}}