Recruiting NCT04748601

Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old

Phase IV Interventional Migraine Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Qudexy XR, Placebo.
Who it may be relevant to: Registry conditions: Migraine Disorders. Basic parameters: 6 years — 11 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 4 Study to Evaluate the Efficacy and Safety of Qudexy(R) XR in the Prevention of Migraine in Children 6 to 11 Years of Age

Overview

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

Interventions

Drug Qudexy XR
Extended-Release Capsule
Drug Placebo
Qudexy XR Matching capsules

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. [Time frame: 16 Weeks]

Eligibility criteria

Inclusion criteria

Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening)
Subject weighs at least 17.0 kg and less than 50.0 kg at Visit 1 (Screening) based on 95 percentile weight for the age range.11
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 \[ICHD 3\]).
Subject had ≥8 self-reported headache days in the 28 days prior to Screening.
Subject has a PedMIDAS score >10, indicating at least mild disruption in daily activities, and <140, indicating extreme disability that may require more comprehensive, multi component therapy.

Exclusion criteria

Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.
Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening).
Subject is currently receiving migraine prevention medication and has initiated or changed the dose within 28 days of Screening or is unwilling to avoid making a change during the duration of the study.
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.
Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR.
Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug.
Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1.
Subject has begun menses and any of the following:

Subject has tested positive for pregnancy; OR
Subject is pregnant, planning pregnancy, or lactating; OR
Subject is taking an oral hormonal contraceptive (either combined \[estrogen and progestogen containing\] or progestogen-only) and is unable or unwilling to switch to an alternative highly effective contraceptive method.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 15 centers

Upsher-Smith Clinical Trial Site #5 — Birmingham
Upsher-Smith Clinical Trial Site #15 — La Jolla
Upsher-Smith Clinical Trials Site #3 — Aurora
Upsher-Smith Clinical Trial Site #1 — Stamford
Upsher-Smith Clinical Trial Site #12 — Loxahatchee Groves
Upsher-Smith Clinical Trial Site #8 — Orlando
Upsher-Smith Clinical Trial Site #14 — Tampa
Upsher-Smith Clinical Trial Site #2 — Ann Arbor
… and 7 more centers

Identifiers

NCT: NCT04748601 · P255-501

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗