Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-30 @ 4:32 AM
Study NCT ID:
NCT00484757
Status:
UNKNOWN
Last Update Posted:
2009-04-03
First Post:
2007-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}], 'ancestors': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-02', 'studyFirstSubmitDate': '2007-06-08', 'studyFirstSubmitQcDate': '2007-06-08', 'lastUpdatePostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of orexine A on sleep, neurocognition and immune-system'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Narcolepsy', 'Orexines', 'sleep', 'cognition', 'cytokines'], 'conditions': ['Narcolepsy']}, 'descriptionModule': {'briefSummary': '15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Narcolepsy\n* Age \\>18\n* Informed consent\n* GERMAN fluently spoken\n\nExclusion Criteria:\n\n* Additional severe psychiatric or somatic disorders\n* Pregnancy or nursing\n* Anemia (Hb\\<10g/dl)'}, 'identificationModule': {'nctId': 'NCT00484757', 'acronym': 'NARKOREX', 'briefTitle': 'Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition', 'organization': {'class': 'OTHER', 'fullName': 'Zentrum für Integrative Psychiatrie'}, 'orgStudyIdInfo': {'id': 'Narkorex'}, 'secondaryIdInfos': [{'id': 'DFG-SFB654/C5-Narkorex'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Orexine A', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Zentrum für Integrative Psychiatrie', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Dunja Hinze-Selch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zentrum für Integrative Psychiatrie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zentrum für Integrative Psychiatrie', 'class': 'OTHER'}}}}