Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT02344316
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2015-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bringing Relief to Adolescents Naturally Using Melatonin for Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Amy.Gelfand@ucsf.edu', 'phone': '415-885-7832', 'title': 'Amy Gelfand, MD', 'organization': 'UCSF Pediatric Headache Program'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Melatonin', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Daytime tiredness', 'notes': 'Daytime tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unscheduled medical visit for migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low iron on routine labs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Episode of vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Accident', 'notes': '1 kicked in the ribs\n\n1 kicked in the testicle\n\n1 passenger in a motor vehicle accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Migraine/Migrainous Days Per 28 Day Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'Group randomized to melatonin 3 mg orally nightly\n\nMelatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Group randomized to placebo orally nightly\n\nPlacebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'final 4 weeks of treatment', 'description': 'Number of Migraine/Migrainous Days Per 28 Day Period in melatonin group and placebo group as measured using an online/mobile device headache diary.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Minutes to Sleep Onset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'Group randomized to melatonin 3 mg orally nightly\n\nMelatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Group randomized to placebo orally nightly\n\nPlacebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Number of minutes to sleep onset as measured by a FitBit.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Recruited From Each Recruitment Strategy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All Participants'}], 'classes': [{'categories': [{'title': 'Clinic recruitment', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Newspaper advertising', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Social media advertising (eg, Facebook and Google+', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Electronic medical record letter invitation', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the enrollment period, approximately 1 year', 'description': 'Each recruitment strategy will be analyzed for number of participants successfully enrolled.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medication Adherence as Measured by Number of Openings Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '27', 'groupId': 'OG000'}, {'value': '60', 'spread': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the "At Home Active Study Period" or Weeks 5-16', 'description': 'eCAP tack caps will be used to measure medication adherence and the number of openings will be recorded per participant.', 'unitOfMeasure': 'Mean Number of Openings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Headache Diary Compliance Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin', 'description': 'Group randomized to melatonin 3 mg orally nightly Melatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Group randomized to placebo orally nightly Placebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 12-16 of the study', 'description': 'Number of participants that had ≥85% headache diary compliance during weeks 12-16 of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Melatonin', 'description': 'Group randomized to melatonin 3 mg orally nightly\n\nMelatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Group randomized to placebo orally nightly\n\nPlacebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'There was a 28 day baseline run-in prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Melatonin', 'description': 'Group randomized to melatonin 3 mg orally nightly\n\nMelatonin: Taken at 9 PM or 1 hour before bedtime, whichever is earlier'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Group randomized to placebo orally nightly\n\nPlacebo: Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '14.1', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '14.5', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2015-01-12', 'resultsFirstSubmitDate': '2017-05-05', 'studyFirstSubmitQcDate': '2015-01-16', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-13', 'studyFirstPostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Migraine/Migrainous Days Per 28 Day Period', 'timeFrame': 'final 4 weeks of treatment', 'description': 'Number of Migraine/Migrainous Days Per 28 Day Period in melatonin group and placebo group as measured using an online/mobile device headache diary.'}], 'secondaryOutcomes': [{'measure': 'Number of Minutes to Sleep Onset', 'timeFrame': '16 weeks', 'description': 'Number of minutes to sleep onset as measured by a FitBit.'}, {'measure': 'Number of Participants Recruited From Each Recruitment Strategy', 'timeFrame': 'During the enrollment period, approximately 1 year', 'description': 'Each recruitment strategy will be analyzed for number of participants successfully enrolled.'}, {'measure': 'Medication Adherence as Measured by Number of Openings Per Participant', 'timeFrame': 'during the "At Home Active Study Period" or Weeks 5-16', 'description': 'eCAP tack caps will be used to measure medication adherence and the number of openings will be recorded per participant.'}, {'measure': 'Headache Diary Compliance Rate', 'timeFrame': 'Weeks 12-16 of the study', 'description': 'Number of participants that had ≥85% headache diary compliance during weeks 12-16 of the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine in Adolescents']}, 'referencesModule': {'references': [{'pmid': '19817880', 'type': 'BACKGROUND', 'citation': 'Masruha MR, Lin J, de Souza Vieira DS, Minett TS, Cipolla-Neto J, Zukerman E, Vilanova LC, Peres MF. Urinary 6-sulphatoxymelatonin levels are depressed in chronic migraine and several comorbidities. Headache. 2010 Mar;50(3):413-9. doi: 10.1111/j.1526-4610.2009.01547.x. Epub 2009 Oct 8.'}, {'pmid': '18594760', 'type': 'BACKGROUND', 'citation': 'Masruha MR, de Souza Vieira DS, Minett TS, Cipolla-Neto J, Zukerman E, Vilanova LC, Peres MF. Low urinary 6-sulphatoxymelatonin concentrations in acute migraine. J Headache Pain. 2008 Aug;9(4):221-4. doi: 10.1007/s10194-008-0047-5. Epub 2008 Jul 2.'}, {'pmid': '16548786', 'type': 'BACKGROUND', 'citation': 'Peres MF, Masruha MR, Zukerman E, Moreira-Filho CA, Cavalheiro EA. Potential therapeutic use of melatonin in migraine and other headache disorders. Expert Opin Investig Drugs. 2006 Apr;15(4):367-75. doi: 10.1517/13543784.15.4.367.'}, {'pmid': '15326268', 'type': 'BACKGROUND', 'citation': 'Peres MF, Zukerman E, da Cunha Tanuri F, Moreira FR, Cipolla-Neto J. Melatonin, 3 mg, is effective for migraine prevention. Neurology. 2004 Aug 24;63(4):757. doi: 10.1212/01.wnl.0000134653.35587.24. No abstract available.'}, {'pmid': '11723194', 'type': 'BACKGROUND', 'citation': 'Peres MF, Sanchez del Rio M, Seabra ML, Tufik S, Abucham J, Cipolla-Neto J, Silberstein SD, Zukerman E. Hypothalamic involvement in chronic migraine. J Neurol Neurosurg Psychiatry. 2001 Dec;71(6):747-51. doi: 10.1136/jnnp.71.6.747.'}, {'pmid': '24909684', 'type': 'BACKGROUND', 'citation': 'Fallah R, Shoroki FF, Ferdosian F. Safety and efficacy of melatonin in pediatric migraine prophylaxis. Curr Drug Saf. 2015;10(2):132-5. doi: 10.2174/1574886309666140605114614.'}]}, 'descriptionModule': {'briefSummary': 'Migraine in adolescents is common and effective and safe preventive treatments are needed. This is a pilot randomized controlled trial of melatonin versus placebo for migraine prevention in adolescents 12-17 years old.', 'detailedDescription': 'This is a pilot randomized controlled trial of melatonin vs. placebo for migraine prevention in adolescents 12-17 years old. The main goal of this pilot study is to estimate variance in the outcome measures to help with planning the future fully powered study. Participants will have an in person enrollment visit, followed by phone follow up visits and headache diary data collection via smart phone or internet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 12-17 years and weight ≥40 kg, to allow consistent dosing for all participants of the melatonin dose that has been found to be effective in adults\n2. Resides in California\n3. Headache fulfills International Classification for Headache Disorders, Third Edition (beta version)33 criteria for episodic migraine (with or without aura) in adolescents\n4. Has been experiencing episodic headaches for at least six months\n5. Experiences between 6-14 days of migraine/migrainous headaches per month at baseline (cutoff for chronic migraine is ≥15 days/month)\n6. Developmentally able to provide age-appropriate level of assent\n7. Has a parent/guardian capable of giving written informed consent\n8. Has daily access to a smartphone in order to be able to complete daily study procedures such as diary completion, and to receive text reminders\n9. Subject and parent agree the adolescent will not use over-the-counter melatonin, or another migraine preventive medication, while participating in the study\n10. Participant and at least one parent speak English\n\nExclusion Criteria:\n\n1. Currently (or within the last 4 weeks) using any medication or device with migraine preventive properties: i.e. topiramate, amitriptyline, nortriptyline, propranolol, metoprolol, sodium valproate, gabapentin, flunarizine, methysergide, riboflavin, butterbur, coenzyme Q10, or the Cefaly TENS device. For onabotulinum toxin, they will have to have been off it for at least three months\n2. Use of other sleep medication or sedating medication, such as benzodiazepines, trazodone, or melatonin receptor agonists\n3. History of allergy or adverse event with previous use of exogenous melatonin\n4. Previous ineffective trial of melatonin 3 mg nightly for migraine prevention, where the trial duration was at least three months in duration\n5. Inability to swallow pills, if this inability persists after instruction on pill-swallowing techniques\n6. History of epilepsy or seizure\n7. Overuse of acute headache medications, wherein medication overuse is defined33 as ≥4 days per month of barbiturate containing compounds, ≥10 days per month of opioid containing compounds, or ≥10 days per month of triptans or ergot-containing compounds. Those using non-specific analgesics ≥15 days per month would also be excluded\n8. Adolescent does not have the cognitive capacity to give verbal assent to participate, or the investigator thinks the adolescent does not have the cognitive capacity to complete the diary, even with parental assistance\n9. For females: Pregnancy, lactating or planning to become pregnant during the study. For males: planning to father a child during the study\n10. Abnormal neurologic examination findings\n11. Serious medical illness of any kind; seriousness as judged by the investigator\n12. The investigator does not think the participant can comply with study procedures, or does not think it is medically appropriate for the participant to be in the study'}, 'identificationModule': {'nctId': 'NCT02344316', 'acronym': 'BRAiN-M', 'briefTitle': 'Bringing Relief to Adolescents Naturally Using Melatonin for Migraine', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Melatonin for Migraine Prevention in Adolescents: A Pilot Remote Trial: "The BRAiN-M Study"', 'orgStudyIdInfo': {'id': '14-14251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Melatonin', 'description': 'Group randomized to melatonin 3 mg orally nightly', 'interventionNames': ['Drug: Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group randomized to placebo orally nightly', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'otherNames': ['Rugby melatonin'], 'description': 'Taken at 9 PM or 1 hour before bedtime, whichever is earlier', 'armGroupLabels': ['Melatonin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90077', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Headache Research and Treatment Program', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Pediatric Brain Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Amy A Gelfand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amy Gelfand', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurology', 'investigatorFullName': 'Amy Gelfand', 'investigatorAffiliation': 'University of California, San Francisco'}}}}