Qudexy XR for Pediatric Migraine Prevention

Recruiting at 7 trial locations

Overseen By PPD Laboratories

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Upsher-Smith Laboratories

Must not be taking: Botox, Migraine preventatives, Investigational drugs

Disqualifiers: Continuous migraines, Allergic to topiramate, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Qudexy XR to determine if it can prevent migraines in children aged 6 to 11. The researchers aim to see if this treatment reduces the number of migraine days for young children who frequently experience these headaches. Participants will receive either Qudexy XR or a placebo (a pill with no active medicine) to compare results. Children who have experienced migraines with or without aura for at least six months and have frequent headaches might be suitable for this trial. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that participants do not change their migraine prevention medication during the study. If you are currently taking such medication and have changed the dose within 28 days before the study, you may not be eligible.

What is the safety track record for Qudexy XR?

Research has shown that Qudexy XR, also known as topiramate, has been studied for safety in children to prevent migraines. It is generally considered safe, though some side effects, such as kidney stones and other mild to moderate reactions, have been noted. The FDA has already approved Qudexy XR for treating seizures in children over the age of 2, indicating its safety for use. Current research explores its use for migraines. As with any treatment, weighing the benefits against possible side effects is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for pediatric migraine, which often involve medications like ibuprofen, acetaminophen, or triptans, Qudexy XR offers a unique approach. This medication is an extended-release form of topiramate, which allows for once-daily dosing, potentially improving adherence and effectiveness. Researchers are excited about Qudexy XR because it targets migraine prevention specifically, rather than just managing symptoms, which could mean fewer migraine days for kids. Additionally, its extended-release formulation might reduce side effects compared to immediate-release topiramate, making it a promising option for young patients.

What is the effectiveness track record for Qudexy XR in preventing pediatric migraines?

Research has shown that topiramate, the main ingredient in Qudexy XR, can significantly reduce the number of migraine days in children. One study found that 82% of children taking topiramate experienced at least a 50% reduction in monthly headaches, compared to 62% of children using propranolol, another common treatment. In this trial, participants will receive either Qudexy XR or a placebo. Qudexy XR is already approved for similar uses, supporting its effectiveness in preventing migraines in children. These findings suggest that Qudexy XR is a promising option for reducing migraines in children aged 6 to 11. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I had 8 or more headache days in the last month.

I have had migraines for at least 6 months.

I weigh between 17.0 kg and 50.0 kg.

Exclusion Criteria

I tried topiramate for migraines for 3 months without success or had side effects.

I am menstruating and either pregnant, planning to become pregnant, breastfeeding, or using oral contraceptives without planning to switch.

I have tried more than 3 migraine prevention medications without success.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Qudexy XR or placebo for the prevention of migraine

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Qudexy XR

Trial Overview 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.

How Is the Trial Designed?

Group I: Qudexy XR Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Qudexy XR is already approved in United States for the following indications:

Approved in United States as Qudexy XR for:

• Prophylaxis of migraine headache in adults and adolescents 12 years of age and older
• Monotherapy for partial-onset seizures and primary generalized tonic-clonic seizures in adults and children 2 years and older
• Adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in adults and children 2 years and older

Who Is Running the Clinical Trial?

Upsher-Smith Laboratories

Lead Sponsor

Trials

11

Recruited

7,100+

Published Research Related to This Trial

USL255, a once-daily extended-release formulation of topiramate, demonstrated a consistent pharmacokinetic profile with predictable plasma concentrations across a wide dosing range (25-1,400 mg) in healthy adults, indicating its potential effectiveness for treating epilepsy.

The maximum tolerated dose (MTD) for USL255 was established at 1,200 mg, and the drug was generally safe and well tolerated, suggesting it could be a viable treatment option for patients with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

USL255 extended-release topiramate: dose-proportional pharmacokinetics and tolerability in healthy volunteers. Clark, AM., Halvorsen, MB., Braun, TL., et al.[2021]

In a study involving 162 children aged 6 to 15, topiramate showed a mean reduction of 2.6 migraine days per month compared to 2.0 days for placebo, indicating a potential benefit in preventing pediatric migraines.

Topiramate was well tolerated, with low discontinuation rates due to adverse events (6.5% for topiramate vs. 4.0% for placebo), and a higher percentage of children (32%) experienced a significant reduction in migraine days compared to those on placebo (14%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topiramate for migraine prevention in children: a randomized, double-blind, placebo-controlled trial. Winner, P., Pearlman, EM., Linder, SL., et al.[2018]

In a study involving 97 children, topiramate significantly reduced the frequency of migraines from an average of 16.5 days per month to 9.4 days by the second follow-up, demonstrating its efficacy as a preventive treatment.

The medication was generally well-tolerated, with common side effects including cognitive issues (12.5%) and weight loss (5.6%), indicating that while effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of topiramate in the prevention of childhood headaches. Hershey, AD., Powers, SW., Vockell, AL., et al.[2019]

In a study of 37 children with migraines, topiramate significantly reduced the average number of headaches per month from 15 to 3 (P < 0.001), indicating its efficacy as a prophylactic treatment for pediatric migraines.

Topiramate was generally safe, with 76% of patients experiencing a good or excellent response, but 27% reported adverse effects, particularly at doses above 2 mg/kg/day, suggesting that a maintenance dose of 2 mg/kg/day or lower is advisable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of topiramate in pediatric migraine. Cruz, MJ., Valencia, I., Legido, A., et al.[2018]

A study involving 60 pediatric patients showed that low-dose topiramate (<2 mg/kg/day) significantly reduced migraine frequency, intensity, and duration over two months, indicating its efficacy in migraine prophylaxis.

Topiramate was well-tolerated with manageable side effects, making it a safe alternative treatment option for preventing migraines in children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective dose of topiramate in pediatric migraine prophylaxis. Abbaskhanian, A., Sadeghi, HR., Erfani, A., et al.[2021]

In a phase III study involving 249 adults with refractory partial-onset seizures, USL255 (200 mg/day) significantly reduced seizure frequency and improved the responder rate compared to placebo, indicating its efficacy as an adjunctive treatment.

USL255 was found to be safe and well tolerated, with a low incidence of neurocognitive side effects, and it did not negatively impact the patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-daily USL255 as adjunctive treatment of partial-onset seizures: randomized phase III study. Chung, SS., Fakhoury, TA., Hogan, RE., et al.[2021]

Topiramate, at doses of 100 or 200 mg per day, significantly reduces the frequency of migraines compared to a placebo, with a responder rate showing nearly three times the effectiveness (OR = 2.97).

While topiramate is effective in preventing migraines, it does have a higher incidence of mild to moderate adverse events compared to placebo, indicating that while it is generally safe, patients should be monitored for side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of efficacy of topiramate in migraine prophylaxis. Guo, Y., Han, X., Yu, T., et al.[2020]

Topiramate is an effective prophylactic treatment for pediatric patients with migraines, showing a significant reduction in headache frequency of 63% to 100% at doses of 100 mg/d and 65% at 200 mg/d, with 83% to 95% of patients experiencing at least a 50% reduction in migraine rate.

The medication is generally well tolerated, although some dose-related side effects like paresthesias, weight loss, and cognitive issues were noted, making the 100 mg/d dose the most favorable in terms of benefit-to-risk ratio.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topiramate for migraine prophylaxis in pediatric patients. Deaton, TL., Mauro, LS.[2018]

Topiramate significantly reduces the number of migraine days per month and the overall migraine-related burden in children and adolescents, based on a meta-analysis of 5 randomized controlled trials involving 531 patients aged 6-17 years.

While topiramate is effective in decreasing migraine frequency, it does not significantly increase the percentage of patients experiencing a 50% reduction in headache days, and it is associated with higher rates of side effects like weight loss and paresthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Topiramate in the Prevention of Pediatric Migraine: An Update Meta-Analysis. Wu, X., Zhang, Y., Lu, M., et al.[2020]

Topiramate XR, a once-daily oral medication, is effective for treating partial-onset seizures and generalized tonic-clonic seizures in patients aged 2 years and older, showing significant improvements in seizure frequency compared to placebo in a multinational phase III study.

The extended-release formulation allows for more consistent drug levels in the body and is generally well tolerated, with most side effects being mild or moderate, making it a convenient option for patients who may struggle with more frequent dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topiramate Extended Release: A Review in Epilepsy. Hoy, SM.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04748601

Qudexy XR for the Prevention of Migraine in Children 6 to ... Study Overview. A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.

2. withpower.com withpower.com/trial/phase-4-migraine-disorders-1-2021-d6c54

Qudexy XR for Pediatric Migraine Prevention Research shows that topiramate, the active ingredient in Qudexy XR, can significantly reduce the number of migraine days in children and lessen the impact of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5507226/

Topiramate for pediatric migraine prevention - PMC Of the children in the topiramate group, 82% had at least a 50% reduction in monthly headache frequency compared with 62% of those in the propranolol group, ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2014/205122Orig1s000SumR.pdf

205122Orig1s000 As discussed below, the pharmacokinetic data/analyses were found to be sufficient to support approval of Qudexy XR, and the clinical study was ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9031827/

Emerging Pharmacological Treatments for Migraine in the ... The combination of topiramate (50 mg/day)/ALA (300 mg/day) was superior in reducing monthly migraine frequency and attack duration to topiramate ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/205122s017lbl.pdf

qudexy® xr - accessdata.fda.gov QUDEXY XR is not indicated for partial- onset seizures in pediatric patients less than 2 years of age. In pediatric patients (ranging from 6 to 17 years of age) ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf

Qudexy XR - accessdata.fda.gov QUDEXY XR is not approved for pediatric patients less than 2 years old [see Use in Specific Populations (8.4)]. Kidney stones have also been reported in ...

8. empr.com empr.com/drug/qudexy-xr/

QUDEXY XR Prescription & Dosage Information - MPR QUDEXY XR prescription and dosage information for physicians and health care professionals. Pharmacology, adverse reactions, warnings, and QUDEXY XRside ...