Qudexy XR for Pediatric Migraine Prevention
Palo Alto (17 mi)Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Upsher-Smith Laboratories
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Is the drug Qudexy XR (topiramate) a promising option for preventing migraines in children?Yes, Qudexy XR (topiramate) is a promising option for preventing migraines in children. Studies show it can significantly reduce the number of headaches in kids, making it an effective choice for migraine prevention.13456
Do I have to stop taking my current medications for the trial?The trial requires that you do not change your current migraine prevention medication during the study. If you have started or changed the dose of such medication within 28 days before screening, you may not be eligible. The protocol does not specify about other medications.
What safety data is available for Qudexy XR in pediatric migraine prevention?Safety data for Qudexy XR (topiramate) in pediatric migraine prevention is available from several studies. These include a randomized, double-blind, placebo-controlled trial assessing its safety and efficacy in children with migraines, and a meta-analysis evaluating the safety of topiramate in migraine prophylaxis. Additionally, the safety and tolerability of USL255, the extended-release form of topiramate, have been evaluated in healthy volunteers and in adults with partial-onset seizures, which may provide relevant safety insights.25678
What data supports the idea that Qudexy XR for Pediatric Migraine Prevention is an effective drug?The available research shows that topiramate, the active ingredient in Qudexy XR, can significantly reduce the number of migraine days per month in children and adolescents. A meta-analysis of five studies with 531 participants found that those taking topiramate had fewer migraine days compared to those taking a placebo. However, while it reduced the overall burden of migraines, it did not significantly increase the percentage of patients who experienced a 50% reduction in headache days. Additionally, topiramate was associated with some side effects like weight loss and tingling sensations.125910
Eligibility Criteria
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.
My daily activities are mildly to severely affected by my condition.
I am between 6 and 11 years old.
Exclusion Criteria
I tried topiramate for migraines for 3 months without success or had side effects.
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 allergic to topiramate or ingredients in Qudexy XR.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Qudexy XRExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Upsher-Smith Clinical Trial Site #14Tampa, FL
Upsher-Smith Clinical Trial Site #13Houston, TX
Upsher-Smith Clinical Trial Site #9Mobile, AL
Upsher-Smith Clinical Trial Site #5Birmingham, AL
More Trial Locations
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Who is running the clinical trial?
Upsher-Smith LaboratoriesLead Sponsor
References
Effectiveness of topiramate in the prevention of childhood headaches. [2019]Migraine is a significant problem for many children. Topiramate has been suggested to be effective for the prophylaxis of migraine in adults, but has not yet been examined in children. The drug has been demonstrated to be safe and effective for childhood seizure disorders. The objective of this study was to demonstrate the safety and efficacy of topiramate for the prevention of pediatric migraine.
Topiramate for migraine prevention in children: a randomized, double-blind, placebo-controlled trial. [2018]To assess the efficacy and safety of topiramate for the prevention of pediatric migraine with or without aura in a double-blind, randomized, placebo-controlled trial.
Efficacy and tolerability of topiramate in pediatric migraine. [2018]About 5-10% of school-age children manifest migraine headaches. Treatment options for pediatric migraine are limited. Topiramate is approved for migraine prophylaxis in adults, but its use in children is limited. We retrospectively reviewed the records of 37 patients, i.e., 22 (60%) girls and 15 (40%) boys (mean age, 14 years; range, 7.3-20.5 years), diagnosed with migraine without aura in 30 (81%), with aura in four (11%), and abdominal, ophthalmoplegic, and catamenial in one each. The mean follow-up was 12 +/- 5 months standard deviation (S.D.). Clinical response was qualified as excellent, good, no change, or worse. Numbers of headaches per month were 15 +/- 7 S.D. prior to treatment and 3 +/- 3.4 S.D. (P 50% migraine reduction) was attained in 28 patients (76%). Ten (27%) patients exhibited adverse effects. Patients taking >2 mg/kg/day were more likely to demonstrate side effects. The mean dose for patients without adverse effects was 1.27 +/- 0.7 mg/kg/day S.D. Those who reported adverse effects were taking a mean dose of 2.8 +/- 1.5 mg/kg/day S.D. This study demonstrated that topiramate is an effective, safe alternative for the prophylaxis of pediatric migraine. An acceptable risk/benefit maintenance dose was
Effective dose of topiramate in pediatric migraine prophylaxis. [2021]Migraine is a common neurological disorder in childhood and adolescence. Topiramate is a new anticonvulsant drug, recently being used in migraine prophylaxis in adults, although it is not approved by the Food and Drug Administration for prevention of pediatric migraine. The present study was planned and performed to evaluate the efficacy of low-dose topiramate in pediatric migraine prophylaxis.
Topiramate for migraine prophylaxis in pediatric patients. [2018]To evaluate the currently published data pertaining to the efficacy and safety of topiramate for prophylaxis of classic and common migraine in pediatric patients.
USL255 extended-release topiramate: dose-proportional pharmacokinetics and tolerability in healthy volunteers. [2021]Evaluate the pharmacokinetics (PK), safety, and tolerability of single doses of once-daily USL255, Qudexy XR (topiramate) extended-release capsules, over a wide dosing range.
Once-daily USL255 as adjunctive treatment of partial-onset seizures: randomized phase III study. [2021]To evaluate the efficacy and safety of USL255, Qudexy(™) XR (topiramate) extended-release capsules, as an adjunctive treatment for refractory partial-onset seizures (POS) in adults taking one to three concomitant antiepileptic drugs.
Meta-analysis of efficacy of topiramate in migraine prophylaxis. [2020]To evaluate the treatment effects and safety of topiramate in migraine prophylaxis.
Topiramate Extended Release: A Review in Epilepsy. [2018]Once-daily oral topiramate extended release (USL255; hereafter referred to as topiramate XR) [QUDEXY(®) XR] is approved in the USA for use as initial monotherapy and adjunctive therapy in patients aged ≥2 years with partial-onset seizures (POS) or primary generalized tonic-clonic seizures and as adjunctive therapy in patients aged ≥2 years with seizures associated with Lennox-Gastaut syndrome. Compared with twice-daily topiramate immediate release at the same total daily dose, topiramate XR provided bioequivalent exposure, an extended absorption rate (permitting convenient once-daily dosing) and more constant therapeutic plasma concentrations (potentially minimizing topiramate-associated adverse events). Switching between the two formulations did not affect the maintenance of topiramate concentrations. Moreover, the contents of a topiramate XR capsule may be sprinkled on to soft food for patients who have difficulty swallowing. In a multinational phase III study in adults with refractory POS, adjunctive topiramate XR was associated with significantly greater improvements from baseline in weekly median seizure frequency and the proportion of patients achieving a ≥50 % reduction in seizure frequency compared with placebo. These benefits were sustained during a 55-week open-label extension study. Adjunctive topiramate XR was generally well tolerated in these studies, with the majority of treatment-emergent adverse events being mild or moderate in intensity. In conclusion, current evidence suggests once-daily topiramate XR extends the treatment options currently available for patients aged ≥2 years with epilepsy, with its dosing regimen potentially delivering tolerability and adherence advantages over AEDs that require more frequent administration.
The Efficacy and Safety of Topiramate in the Prevention of Pediatric Migraine: An Update Meta-Analysis. [2020]Background: Migraine is the most common acute primary headache in children and adolescents. In 2014, topiramate became the first preventive drug for migraine, approved by the Food and Drug Administration (FDA) for adolescents. This meta-analysis was aimed to evaluate the efficacy and safety of topiramate in the prevention of pediatric migraine. Methods: We searched the PubMed, EMBASE, Cochrane Library, and Chinese National Knowledge Infrastructure (CNKI) databases up to June 2019 for eligible randomized controlled trials (RCTs). The primary outcomes were mean migraine days per month, ≥50% reduction rate, and Pediatric Migraine Disability Assessment Scale (PedMIDAS) scores. RevMan5.3 software was performed for statistical analysis. Results: Overall, 5 RCTs recruiting 531 patients (6-17 years of age) were included in the meta-analysis. The target dose of topiramate was 2 mg/kg (the maintenance phase was 12 weeks), 2-3 mg/kg, 50 mg/day, and 100 mg/day (maintaining for 16 weeks), respectively, in the included studies. Our results demonstrate that participants receiving topiramate had a significant advantage in remitting the monthly migraine days than those receiving placebo, with a mean difference (MD) of -0.78 (n = 531; 95% CI, -1.23 to -0.32; Z = 3.37; P = 0.0008). Topiramate could also reduce the mean PedMIDAS scores (n = 238; 95% CI, -16.53 to -0.49; Z = 2.43; P = 0.04). However, there was no significant difference in the percentage of patients experiencing a ≥50% reduction in monthly headache days between topiramate and placebo groups (n = 531; 95% CI, 0.94-1.77; Z = 1.58; P = 0.11). Topiramate was associated with higher rates of side effects such as weight decrease (n = 395; 95% CI, 2.73-22.98; Z = 3.81; P < 0.01) and paresthesia (n = 531; 95% CI, 3.05-13.18; Z = 4.94; P < 0.01). Conclusions: Topiramate can significantly decrease monthly headache days and migraine-related burden in migraine patients <18 years old. However, it failed to increase 50% response rate. Adverse events seem to be more frequent in topiramate-treated children.