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Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine

NCT03885154 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-10-07

Study results available
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Summary

The objective of this study is to compare clinical efficacy and tolerability of valproic acid (VPA) therapy versus dihydroergotamine (DHE) as abortive therapy in pediatric migraine.

Conditions

  • Migraine in Children

Interventions

DRUG

Valproic Acid (VPA)

IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours

DRUG

Dihydroergotamine (DHE)

0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg

Sponsors & Collaborators

  • Kimberly S Jones

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2019-03-19
Completion
2019-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03885154 on ClinicalTrials.gov