Phase 4 Migraine Trial, Recruiting NCT04748601 Sponsor: Upsher-Smith Laboratories Condition: Migraine
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Phase 4 Migraine Trial, Recruiting

NCT04748601
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children who are female or male, aged 6 to 11 years old at the screening visit
  • Children who weigh at least 17.0 kg and less than 50.0 kg at the screening visit
  • Children who have had headaches consistent with a migraine diagnosis (with or without aura) for at least 6 months
  • Children who had 8 or more headache days in the 28 days before screening
  • Children whose migraine condition scores above 10 and below 140 on a scale called the PedMIDAS, which measures how much migraines disrupt daily life — indicating at least mild disruption but not extreme disability

Who may not be able to join:

  • Children who have had a continuous, non-stop headache lasting an entire 28-day period
  • Children who are currently receiving, or have received, Botox (Botulinum toxin) treatment within the 3 months before screening
  • Children who are currently taking migraine prevention medication and have started or changed the dose within 28 days of screening, or whose family is unwilling to avoid changing the dose during the study
  • Children who have previously tried topiramate for at least 3 months at an appropriate dose for migraine prevention, and it did not work or caused problematic side effects
  • Children who have already tried and had inadequate results from more than 3 different migraine prevention medications
  • Children with a known allergy to topiramate or any ingredient in the study drug (Qudexy XR)
  • Children with a diagnosed or historical medical condition that could interfere with their safety or with evaluating the study drug (confirm with trial site)
  • Children who are currently using, or have used within the past 30 days, any other experimental drug or device
  • Children who have begun their menstrual period and any one of the following applies: a pregnancy test has come back positive; the child is pregnant, planning to become pregnant, or breastfeeding; or the child is taking a hormonal contraceptive pill and is unable or unwilling to switch to another highly effective contraceptive method

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 1-877-302-2879

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Upsher-Smith Laboratories
Registry
ClinicalTrials.gov
Start date
19 February 2021
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov