Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-31 @ 8:31 PM
Study NCT ID:
NCT00363506
Status:
UNKNOWN
Last Update Posted:
2008-04-24
First Post:
2006-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
American Migraine Prevention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-04-22', 'studyFirstSubmitDate': '2006-08-09', 'studyFirstSubmitQcDate': '2006-08-11', 'lastUpdatePostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days'}]}, 'conditionsModule': {'keywords': ['nutritional', 'C10.228.140.546.399.750'], 'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the use of nutritional supplementation and dietary management for the reduction in frequency, duration, and intensity of migraine headache pain.', 'detailedDescription': 'AMPS, the American Migraine Prevention Study Program is a home based nutritional study for migraine prevention. It is designed to evaluate a nutritional supplement along with proper diet, and trigger management that may prevent migraines or reduce the frequency, duration and intensity of migraine headache pain.\n\nThe AMPS Program is availalbe nationwide. It is a home based study program.\n\nDuring the three month study period, participants will be asked to take a daily nutritional supplement and follow a recommended diet to avoid potential migraine triggers. Participants will be asked to maintain a headache log and submit headache questionnaires at the beginning and end of the study. Participants do not have to travel and can participate from their current location.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of migraines\n* Ages 18-72\n* Migraines more than once per month\n* Diagnosed migraines for more than one year\n\nExclusion Criteria:\n\n* Pregnant/nursing'}, 'identificationModule': {'nctId': 'NCT00363506', 'briefTitle': 'American Migraine Prevention Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dynamic Health Resources'}, 'officialTitle': 'Nutritional Based Protocol to Balance Serotonin for the Prevention or Reduced Frequency/Duration/Intensity of Migraines', 'orgStudyIdInfo': {'id': 'DHR-757962-7081'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Serotona Plus and dietary behavior management', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23320', 'city': 'Chesapeake', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John J Carvalho, MBA', 'role': 'CONTACT', 'email': 'jjc@dynamichealthresources.com', 'phone': '757-572-7781'}, {'name': 'Katherine huffman, MA', 'role': 'CONTACT', 'email': 'Katherine@DynamicHealthResources.com', 'phone': '571-334-9154'}, {'name': 'Dr. John A Allocca, PhD, ScD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nationwide home based study program', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}], 'centralContacts': [{'name': 'John J Carvalho, MBA', 'role': 'CONTACT', 'email': 'jjc@dynamichealthresources.com', 'phone': '757-721-7781'}, {'name': 'Katherine huffman, MA', 'role': 'CONTACT', 'email': 'Katherine@dynamichealthresources.com', 'phone': '571-334-9154'}], 'overallOfficials': [{'name': 'John J Carvalho, MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Dynamic Health Resources'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dynamic Health Resources', 'class': 'INDUSTRY'}}}}