NCT03597529

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 15, 2021

Completed
Last Updated

June 15, 2021

Status Verified

May 1, 2021

Enrollment Period

2.2 years

First QC Date

June 26, 2017

Results QC Date

April 20, 2021

Last Update Submit

May 19, 2021

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Low-Dose Melatonin (mg)

EXPERIMENTAL

melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin

Drug: Melatonin

High-Dose Melatonin (mg)

EXPERIMENTAL

melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin

Drug: Melatonin

Interventions

MelatoninDRUG

melatonin

High-Dose Melatonin (mg)Low-Dose Melatonin (mg)

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1 migraine attack per month on average.
  • Age 3-17 years
  • Dissatisfaction with previous acute treatments, for one or more of the following reasons: a) One or more previously tried acute medications have not been effective, or adequately effective, b) previously tried acute treatments have caused side effects, or C) patient/family would prefer a natural supplement for acute treatment over medication treatment
  • If of driving age, teen participant agrees not to drive for at least 8 hours after treating with melatonin.

You may not qualify if:

  • Allergy or intolerance to melatonin, or to chocolate.
  • Opioid or barbiturate overuse as defined in ICHD
  • Pregnant/lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco, (UCSF)

San Francisco, California, 94158, United States

Location

Related Publications (3)

  • 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.

    PMID: 20713557BACKGROUND

  • 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.

    PMID: 19223003BACKGROUND

  • 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.

    PMID: 22141591BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr. Amy A. Gelfand
Organization
Director, Child and Adolescent Headache Program, UCSF Benioff Children's Hospitals
Amy.Gelfand@ucsf.edu
415-502-1914

Study Officials

  • Amy A Gelfand, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 24, 2018

Study Start

September 25, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 15, 2021

Results First Posted

June 15, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)