← Back to Search

Anti-epileptic drug

Qudexy XR for Pediatric Migraine Prevention

Phase 4
Recruiting
Research Sponsored by Upsher-Smith Laboratories
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject had ≥8 self-reported headache days in the 28 days prior to Screening
Subject has at least a 6-month history of headaches consistent with a diagnosis of migraine with or without aura (International Classification of Headache Disorders, 3rd Edition [ICHD 3])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will test if Qudexy XR can prevent migraines in children aged 6 to 11.

Who is the study for?
This trial is for children aged 6 to 11 who weigh between 17.0 kg and less than 50.0 kg, have had migraines for at least six months, and experience more than eight headache days per month. They should not have failed topiramate treatment before or be on certain contraceptives or migraine prevention medications.Check my eligibility
What is being tested?
The study tests Qudexy XR's effectiveness in preventing migraines in kids against a placebo (a substance with no therapeutic effect). It's a Phase 4 trial, meaning the drug is already approved but needs further testing in this age group.See study design
What are the potential side effects?
While specific side effects are not listed here, Qudexy XR contains topiramate which can cause tingling sensations, drowsiness, dizziness, taste changes, weight loss and could potentially affect growth rates in children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had 8 or more headache days in the last month.
Select...
I have had migraines for at least 6 months.
Select...
I weigh between 17.0 kg and 50.0 kg.
Select...
My daily activities are mildly to severely affected by my condition.
Select...
I am between 6 and 11 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline (last 28 days Run-In Period) in the monthly number of headache days during the 8-week Maintenance Period based on the diary.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Qudexy XRExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Upsher-Smith LaboratoriesLead Sponsor
9 Previous Clinical Trials
1,671 Total Patients Enrolled
1 Trials studying Migraine
107 Patients Enrolled for Migraine

Media Library

Qudexy XR (Anti-epileptic drug) Clinical Trial Eligibility Overview. Trial Name: NCT04748601 — Phase 4
Migraine Research Study Groups: Qudexy XR, Placebo
Migraine Clinical Trial 2023: Qudexy XR Highlights & Side Effects. Trial Name: NCT04748601 — Phase 4
Qudexy XR (Anti-epileptic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04748601 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what indications is Qudexy XR usually prescribed?

"Qudexy XR is a traditional treatment for hypertension. Other potential uses of this medication include prophylaxis against migraine headaches, epilepsy, and at least one obesity-related comorbidity."

Answered by AI

At what number of medical centers is this research endeavor being conducted?

"This clinical trial has 11 distinct enrolment sites, including Upsher-Smith Clinical Trial Site #9 in Mobile, Upsher-Smith Clinical Trial Site #5 in Birmingham, and Upsher-Smith Clinical Trial Site#1 in Stamford. 8 other locations are also hosting this study."

Answered by AI

Has the federal regulatory body given its blessing to Qudexy XR?

"The safety of Qudexy XR is rated 3 out of 3, as this medication has already been approved for use in Phase 4 clinical trials."

Answered by AI

How many participants are being recruited for this research program?

"Affirmative. The listing of this clinical trial on the website for clinicaltrials.gov confirms that it is actively recruiting, with 132 patients needed from 11 different sites. It was first posted in February 2021 and most recently updated at the end of April 2022."

Answered by AI

Are there any other instances of Qudexy XR being utilized for research purposes?

"Originally studied in 2013 at UC Davis Medical Center, Qudexy XR has since been the subject of 18417 clinical trials. At present, 18 separate research projects are ongoing, with many based out of Mobile, Alabama."

Answered by AI

Are there any eligibility criteria for enrolling in this experiment?

"This clinical trial has room for 132 children between the ages of six and eleven who have been diagnosed with sick headache. Additional inclusion criteria are that participants must possess a minimum 6-month history of headaches which aligns to ICHD 3, weigh no less than 17kg and up 50 kg based on 95 percentile weight for their age, record 8 or more self-reported headache days in the month prior to screening, and present a PedMIDAS score greater than 10 but lower than 140."

Answered by AI

Is eligibility for this clinical trial limited to individuals aged 20 and over?

"This clinical trial has established an age range of 6-11 as the required parameters for patient participation."

Answered by AI

Are participants being admitted to this experiment currently?

"Affirmative, per the clinicaltrials.gov entry for this trial, enrollment is currently open to candidates. The protocol was published on February 19th 2021 and has since been revised on April 26th 2022. 132 participants across 11 sites are being sought out for inclusion in the study."

Answered by AI
~56 spots leftby Sep 2026