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Existing treatments for acute migraine are not effective for all children and adolescents, and can cause side effects. Investigator propose a dose-finding study of melatonin for acute migraine treatment in children and adolescents to determine the best dose to bring forward in a future fully-powered efficacy trial.
This pilot randomized trial is a dose-finding study to determine which dose of melatonin is most effective for treating acute migraine in children and adolescents who have episodic migraine. Investigator will identify the most effective dose to pull forward into a future fully-powered placebo-controlled efficacy study. If both doses are equally effective, Investigator will bring forward the best tolerated dose. If doses are equally well tolerated, Investigator will bring forward the lowest effective dose, as this will minimize cost to families should this treatment become widely adopted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose Melatonin (mg) | Experimental | melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin |
|
| High-Dose Melatonin (mg) | Experimental | melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | melatonin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Visual Analog Scale (VAS) Score | Visual Analog Scale (VAS) score ranges from 0-10, measured in cm, 0 indicating no pain and 10 indicating the worst pain. | Baseline (Time 0) and 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy A Gelfand, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco, (UCSF) | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20713557 | Background | Victor TW, Hu X, Campbell JC, Buse DC, Lipton RB. Migraine prevalence by age and sex in the United States: a life-span study. Cephalalgia. 2010 Sep;30(9):1065-72. doi: 10.1177/0333102409355601. Epub 2010 Mar 12. | |
| 19223003 | Background | Ambriz-Tututi M, Rocha-Gonzalez HI, Cruz SL, Granados-Soto V. Melatonin: a hormone that modulates pain. Life Sci. 2009 Apr 10;84(15-16):489-98. doi: 10.1016/j.lfs.2009.01.024. Epub 2009 Feb 15. |
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Out of 102 participants who were assessed for eligibility, 84 met inclusion criteria and were randomized to a treatment.
Recruitment ran from September 25, 2017 until November 5, 2019. Eligibility was assessed by a pediatric headache specialist.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-Dose Melatonin (mg) | melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin |
| FG001 | High-Dose Melatonin (mg) | melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-Dose Melatonin (mg) | melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin |
| BG001 | High-Dose Melatonin (mg) | melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Visual Analog Scale (VAS) Score | Visual Analog Scale (VAS) score ranges from 0-10, measured in cm, 0 indicating no pain and 10 indicating the worst pain. | Posted | Mean | Standard Deviation | cm | Baseline (Time 0) and 2 hours |
|
Participants were asked to report adverse events at 2 hours and at 24 hours after taking study treatment.
Not all participants reported on the presence or absence of adverse events and some had more than 1 adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-Dose Melatonin (mg) | melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Proportion who napped within 2 hours after treating | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy A. Gelfand | Director, Child and Adolescent Headache Program, UCSF Benioff Children's Hospitals | 415-502-1914 | Amy.Gelfand@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2018 | Mar 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 22141591 | Background | Gitto E, Aversa S, Salpietro CD, Barberi I, Arrigo T, Trimarchi G, Reiter RJ, Pellegrino S. Pain in neonatal intensive care: role of melatonin as an analgesic antioxidant. J Pineal Res. 2012 Apr;52(3):291-5. doi: 10.1111/j.1600-079X.2011.00941.x. Epub 2011 Dec 5. |
| Withdrawal by Subject |
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| Non-compliant with study activities |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Data on this baseline measurement is missing for one participant. While there are 84 participants total in the study, there is sex data for 83 participants total. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Headache days per month (self report) | Mean | Standard Deviation | days per month |
|
| Aura | Analysis population differs from the Overall number of baseline participants because data was not provided for this measure by all participants. | Count of Participants | Participants |
|
| Reason(s) for dissatisfaction with previous acute medications | Some participants selected one or more reasons for dissatisfaction with previous acute medications. | Number | participants |
|
| Currently on migraine preventive | Analysis population differs from the Overall number of baseline participants because data was not provided for this measure by all participants. | Count of Participants | Participants |
|
| Melatonin Dose/Weight | Mean | Standard Deviation | mg/kg |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 13 |
| 19 |
| EG001 | High-Dose Melatonin (mg) | melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin | 0 | 21 | 0 | 21 | 17 | 21 |
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| Weakness | Nervous system disorders | Systematic Assessment |
|
| Clumsiness | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |