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Qudexy XR for Pediatric Migraine Prevention
Study Summary
This trial will test if Qudexy XR can prevent migraines in children aged 6 to 11.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I had 8 or more headache days in the last month.I tried topiramate for migraines for 3 months without success or had side effects.I have had migraines for at least 6 months.I weigh between 17.0 kg and 50.0 kg.I am menstruating and either pregnant, planning to become pregnant, breastfeeding, or using oral contraceptives without planning to switch.My daily activities are mildly to severely affected by my condition.I have tried more than 3 migraine prevention medications without success.I have had a headache that hasn't stopped for 28 days.I am on migraine prevention medication and haven't changed the dose in the last 28 days.I have used Botox within the last 3 months.I am allergic to topiramate or ingredients in Qudexy XR.I have a condition that might affect the study drug's safety or results.I have not used any experimental drugs or devices in the last 30 days.I am between 6 and 11 years old.
- Group 1: Qudexy XR
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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