Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-03-03 @ 12:02 AM
Study NCT ID:
NCT02229032
Status:
COMPLETED
Last Update Posted:
2017-12-15
First Post:
2014-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Analysis Between Charlotte's Web Responders Versus Non- Responders in a Dravet Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004831', 'term': 'Epilepsies, Myoclonic'}], 'ancestors': [{'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'saliva for DNA analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2014-08-27', 'studyFirstSubmitQcDate': '2014-08-28', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'genetic differences between patients with Dravet Syndrome (SCN1A gene mutation) who appear to respond to high concentration cannabidiol (CBD) oil therapy versus those who do not.', 'timeFrame': '1 day', 'description': 'Patients completing three months of therapy with a seizure reduction of \\>50% will be designated a "Responder" and patients who discontinue therapy for any reason prior to 3 months or have a \\<=50% seizure reduction will be designated "Non-Responder". Between-groups genetic analysis will be performed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dravet Syndrome', 'cannabidiol therapy', "Charlotte's Web"], 'conditions': ['Dravet Syndrome']}, 'descriptionModule': {'briefSummary': "There is tremendous curiosity about medical marijuana and the treatment of epilepsy. In a specific genetic epilepsy known as Dravet Syndrome, a mutation occurs affecting the SCN1A gene. A specific strain of marijuana known as Charlotte's Web, available in Colorado, may have activity in this catastrophic epilepsy syndrome. Anecdotal reports suggest both success and lack of response with this therapy. Genetic analysis of the differences between Dravet responders and non-responders may prove useful for identifying patients likely to be helped by this therapy, as well as shed light on the putative mechanisms by which marijuana may exert any antiepileptic effect."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Dravet Syndrome, ages 1-50, who are self- seeking therapy with Charlotte's Web strain of medical marijuana with the assistance of a medical marijuana doctor, but are still naïve to therapy", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 1-50 with gene confirmed Dravet Syndrome\n* uncontrolled epilepsy, having failed at least 2 prior treatments (including appropriate Anti-epileptic drugs, ketogenic diet, vagus nerve stimulation Therapy)\n* Seizure frequency should be more than 2 visually countable motor seizures per week (tonic clonic, tonic, clonic, myoclonic, or astatic)\n* care providers able to identify convulsive seizures, drop attacks, or tonic seizures, or any combination of countable seizure types\n* self- seeking therapy with Charlotte's Web strain of medical marijuana with the assistance of a medical marijuana doctor, but are still naïve to therapy\n* care provider able to complete seizure count diary\n* able to obtain oral swab sample from subject with Dravet Syndrome\n* agree to forfeit any right to results of genetic analysis\n\nExclusion Criteria:\n\n* subjects having non-epileptic seizures that are not distinguishable from epileptic seizures by the care provider\n* prisoners\n* pregnant women\n* failure to forfeit right to results of genetic analysis"}, 'identificationModule': {'nctId': 'NCT02229032', 'briefTitle': "Genetic Analysis Between Charlotte's Web Responders Versus Non- Responders in a Dravet Population", 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': "Genetic Analysis Between Charlotte's Web Responders Versus Non- Responders in a Dravet Population", 'orgStudyIdInfo': {'id': '14-0294'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dravet Sydrome', 'description': "Patients with Dravet Syndrome who are self-seeking therapy with Charlotte's Web strain of medical marijuana with the assistance of a medical marijuana doctor, but are still naïve to therapy"}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Edward Maa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Denver Health Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Denver Health Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}