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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])
Must not have
Subject has previously failed an adequate trial of topiramate (at least 3 months duration at a clinically appropriate dose) for prophylaxis of migraine headache due to lack of efficacy or AEs
Subject has previously failed an adequate trial of >3 migraine preventative medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I tried topiramate for migraines for 3 months without success or had side effects.
Select...
I have tried more than 3 migraine prevention medications without success.
Select...
I have had a headache that hasn't stopped for 28 days.
Select...
I am allergic to topiramate or ingredients in Qudexy XR.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
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.
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
1,673 Total Patients Enrolled
1 Trials studying Migraine
107 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Qudexy XR
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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