CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 160 enrolled
Drug / intervention
Magnesium 400Mg +2 moredrug
Likely dose
Magnesium 400Mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01756209
NCT01756209Phase 4Completed

The Effects of Acetaminophen and Ibuprofen With and Without Magnesium in the Treatment of Primary Migraine in Childhood

University of Catanzaro·interventional·Posted Dec 25, 2012·Updated Mar 25, 2020

In Brief

A Phase 4 clinical trial evaluating Magnesium 400Mg, Ibuprofen 10 mg/kg, and 1 other intervention for Migraine. Completed, enrolled 160 participants across 1 site.

Detailed Summary

Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or acetaminophen for the acute treatment of primary migraine in children in or out prophylactic treatment with magnesium. Methods: The study had been approved by the Researchers Ethics Committee of the "Pugliese-Ciaccio" Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and the children ranging from the ages of 5 to 18 years with at least four attack/month of primary migraine were enrolled. A Visual Analogical Scale was used to evaluate pain intensity at the moment of admission to the study (start of the study) and every month up to 18 months later (end of the study).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 25, 2012
Enrollment StartJan 1, 2010
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.5 years ago

Interventions

Magnesium 400Mgdrug

magnesium 400 mg + conventional treatment

Ibuprofen 10 mg/kgdrug

ibuprofen 10 mg/kg oral single dose

acetaminophen 15 mg/kgdrug

Acetaminophen 15 mg/kg oral single dose