NCT04748601 · Upsher-Smith Laboratories
Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
What this study is about
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening) 2. 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 3. 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 \[ICHD 3\]). 4. Subject had ≥8 self-reported headache days in the 28 days prior to Screening. 5. 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. 2. Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening). 3. Subject is currently receiving migraine pre
Where
- Birmingham, Alabama
- La Jolla, California
- Aurora, Colorado
- Stamford, Connecticut
- Loxahatchee Groves, Florida
- Orlando, Florida
- Tampa, Florida
- Ann Arbor, Michigan
- Jackson, Mississippi
- Bridgeton, Missouri
- Cincinnati, Ohio
- Portland, Oregon
And 3 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2025 · Source of record for eligibility and locations