BridgeMD
Prevention study for Migraine Disorders
Official title Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
ClinicalTrials.gov ID: NCT04748601
What this study is testing
What is Qudexy XR?
Qudexy XR is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for migraine disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Subject has previously failed an adequate trial of topiramate (at least 3 months duration at a clinically appropriate dose) for prophylaxis of...
- 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.
See the full eligibility 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.
- 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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Aurora, Colorado, United States
- Stamford, Connecticut, United States
- Loxahatchee Groves, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Ann Arbor, Michigan, United States
- Jackson, Mississippi, United States
- Bridgeton, Missouri, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Springfield, Oregon, United States
- McAllen, Texas, United States
- Huntington, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; Aurora, Colorado, United States; Stamford, Connecticut, United States; Loxahatchee Groves, Florida, United States; Orlando, Florida, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.