Last reviewed · How we verify
NCT04748601
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
Phase 4 trial testing Qudexy XR in Migraine Disorders in 132 participants. Currently enrolling.
1 September 2026
Quick facts
| Lead sponsor | Upsher-Smith Laboratories |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 19 February 2021 |
| Primary completion | 1 September 2026 |
| Estimated completion | 1 September 2026 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- Qudexy XR — full drug profile →
- Placebo
Conditions studied
- Migraine Disorders — all drugs for Migraine Disorders →
Sponsor
Upsher-Smith Laboratories — full company profile →
Who can join
Adults 6 to 11, any sex, with Migraine Disorders. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging Pharmacological Treatments for Migraine in the Pediatric Population.
Iannone LF, De Cesaris F, Geppetti P. · · 2022 · cited 10× · PMID 35455026 · DOI 10.3390/life12040536 -
What's in the pipeline for pediatric headache treatment?
Gelfand AA, Szperka CL. · · 2026 · PMID 41431120 · DOI 10.1111/head.70037
Verify or expand the search:
- PubMed search for NCT04748601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Migraine Disorders
Currently open trials in the same condition.
- NCT07170176 — Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine · NA · recruiting
- NCT07093138 — Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatmen · Phase 4 · recruiting
- NCT06426316 — The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology. · NA · recruiting
- NCT06623188 — Treatment of Episodic Migraine With AURICular Neuromodulation · NA · recruiting
- NCT06535880 — Trigeminal Brainstem Mapping 2: Higher Cortical Strucureas As Well As Subnuclei of the Spinal Trigeminal Nucleus · NA · recruiting
Other Upsher-Smith Laboratories trials
Trials by the same sponsor.
- NCT04558567 — Vogelxo(R) ABPM Study in Hypogandal Men · Phase 4 · completed
- NCT02856802 — An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg) · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04748601 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Upsher-Smith Laboratories
- Last refreshed: 22 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04748601.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing