Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-09 @ 3:01 AM
Study NCT ID:
NCT02266966
Status:
COMPLETED
Last Update Posted:
2016-10-13
First Post:
2014-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2014-09-19', 'studyFirstSubmitQcDate': '2014-10-13', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor system cortical areas activation magnitude during a paced motor task.', 'timeFrame': '1 day (Period 1/Day +1, Period 2/Day +8)', 'description': '1. Location coordinates (x,y,z),\n2. Voxel cluster size expressed in terms number of voxels,\n3. Intensity as measured with a Z-score'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) as a measure of safety and tolerability', 'timeFrame': 'up to 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subject']}, 'descriptionModule': {'briefSummary': 'The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale right-handed\\*, healthy volunteers 18 to 40 years of age. Having signed and dated an informed consent form\n\nExclusion Criteria:\n\nAny significant disease or history of any clinically important drug allergy. Acute disease state within 7 days. History of drug abuse within 1 year. History or current excessive use of alcohol and / or positive alcohol screen. History of narrow angle glaucoma, seizures or epilepsy or brain injury. History of Gluten sensitivity, Gluten intolerance (celiac disease), Wheat allergy or Wheat intolerance.\n\nHistory of obstructive voiding symptoms, including urinary retention.'}, 'identificationModule': {'nctId': 'NCT02266966', 'briefTitle': 'Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'orgStudyIdInfo': {'id': 'F02695LP105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F2695', 'description': 'Single dose - 2 capsules / Day on Day 1 and Day 8', 'interventionNames': ['Drug: F2695']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Single dose - 2 capsules / Day on Day 1 and Day 8', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'F2695', 'type': 'DRUG', 'armGroupLabels': ['F2695']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': "Centre d'Investigation Clinique (CIC)", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'François Chollet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Purpan CHU TOULOUSE, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}