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Melatonin for Adolescent Migraine Prevention Study

NCT03150797 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-10-13

Study results available
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Summary

This will be a randomized, multi-site double-blind placebo-controlled trial of melatonin (2 different dosing arms) vs. placebo for migraine prevention in adolescents. We intend to enroll approximately 210 participants over 15 months at two sites: UCLA and UCSF. The duration of participation for each participant will be 4 months.

Conditions

Interventions

DRUG

Melatonin

Melatonin

DRUG

Placebo oral capsule

Placebo

Sponsors & Collaborators

Principal Investigators

  • Amy A Gelfand, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2019-12-01
Completion
2019-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150797 on ClinicalTrials.gov