Migraine DisordersPhase 4NCT04748601
Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
A Phase 4 study testing Qudexy XR in people with Migraine Disorders, run by Upsher-Smith Laboratories at 15 sites in United States.
Trial summary
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Qudexy XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 15 sitesUnited States
- Study dates
- 19 Feb 2021to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 6 recruiting
- Withdrawn
Upsher-Smith Clinical Trial Site #2
Ann Arbor, Michigan, 48104
- Withdrawn
Upsher-Smith Clinical Trials Site #3
Aurora, Colorado, 80045
- Withdrawn
Upsher-Smith Clinical Trial Site #5
Birmingham, Alabama, 35205
- Withdrawn
Upsher-Smith Clinical Trial Site #10
Bridgeton, Missouri, 63044
- Recruiting
Upsher-Smith Clinical Trial Site #4
Cincinnati, Ohio, 45229
- Recruiting
Upsher-Smith Clinical Trial Site #9
Huntington, West Virginia, 25701
- Withdrawn
Upsher-Smith Clinical Trial Site #11
Jackson, Mississippi, 39216
- Recruiting
Upsher-Smith Clinical Trial Site #15
La Jolla, California, 92093
- Withdrawn
Upsher-Smith Clinical Trial Site #12
Loxahatchee Groves, Florida, 33470
- Withdrawn
Upsher-Smith Clinical Trial Site #13
McAllen, Texas, 78503
- Withdrawn
Upsher-Smith Clinical Trial Site #8
Orlando, Florida, 32789
- Recruiting
Upsher-Smith Clinical Trial Site #6
Portland, Oregon, 97239
- Recruiting
Upsher-Smith Clinical Trials Site #7
Springfield, Oregon, 97477
- Completed
Upsher-Smith Clinical Trial Site #1
Stamford, Connecticut, 06901
- Recruiting
Upsher-Smith Clinical Trial Site #14
Tampa, Florida, 33620
About this study
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
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
- Conditions
- Migraine Disorders
- Being tested
- Qudexy XR, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qudexy XRDrug
Extended-Release Capsule
PlaceboDrug
Qudexy XR Matching capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Qudexy XR | Experimental | Not described Receives: Drug: Qudexy XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start19 Feb 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Upsher-Smith Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748601
- Sponsor's protocol ID
- P255-501
- Status last verified
- Jan 2025
- First submitted
- 5 Feb 2021
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04748601
- Acronym / sponsor ID
- P255-501
- Conditions
- Migraine Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Upsher-Smith LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Qudexy XR | Experimental | Drug: Qudexy XR |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qudexy XRExtended-Release Capsule | Drug | Qudexy XR |
| PlaceboQudexy XR Matching capsules | Drug | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Qudexy XR in people with Migraine Disorders, run by Upsher-Smith Laboratories at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PPD Laboratories (1-877-302-2879, uslinfo@upsher-smith.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.