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NCT03526874 · ClinicalTrials.gov registry record · Phase 3
Occipital Blocks for Acute Migraine
A Phase 3 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
NCT03526874: Completed Phase 3 study, sponsored by Children's Hospital of Philadelphia.
NCT03526874 is a Phase 3 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 63 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03526874, a Phase 3 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
Study Summary
Migraine affects 10-28% of children and adolescents and yet 20-30% of patients are ineffectively treated with current oral and nasal options. Peripheral nerve blocks (PNBs), injections of local anesthetics over branches of the occipital and/or trigeminal nerves, have been associated with possible benefit for pediatric headaches in case series, and may be useful for both acute and preventive treatment of migraine for children who fail less invasive treatments. In fact, 80% of pediatric headache specialists reported using peripheral nerve blocks and carry low risk of serious side effects; however, peripheral nerve blocks have never been tested, formally, in a randomized pediatric trial. By applying a novel design that utilizes lidocaine cream as a run-in step, investigators intend to test the efficacy of the most commonly used peripheral nerve block, the greater occipital nerve (GON) block, as an acute treatment for pediatric migraine and determine whether lidocaine cream leads to successful blinding of the injection. The GON block is expected to prove effective in decreasing the pain of migraine, with lidocaine being superior to saline and lidocaine cream maintaining blinding.
Primary Outcome
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Numeric Rating Scale (NRS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. NRS scale is a 0 to 10 scale, with 0 meaning no pain and 10 meaning "the worse pain imaginable". A mean change of 2-points has been shown to be clinically relevant.
Interventions
- DRUG Normal Saline
- DRUG Lidocaine 4% Topical Application Cream [LMX 4]
- DRUG Lidocaine Hydrochloride 2 mg/mL Injectable Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2019-04-03 |
| Est. Completion | 2023-03-10 |
| Phase | Phase 3 |
What the finished NCT03526874 record still lists
NCT03526874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Normal Saline is the first listed.
NCT03526874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03526874 about?
NCT03526874 is a clinical study titled "Occipital Blocks for Acute Migraine". Migraine affects 10-28% of children and adolescents and yet 20-30% of patients are ineffectively treated with current oral and nasal options. Peripheral nerve blocks (PNBs), injections of local anesthetics over branches of the occipital and/or trigeminal nerves, have been associated with possible be...
What is the current status of trial NCT03526874?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2019-04-03. Estimated completion is 2023-03-10.
What interventions are being tested in trial NCT03526874?
The interventions under investigation include: Normal Saline (DRUG), Lidocaine 4% Topical Application Cream [LMX 4] (DRUG), Lidocaine Hydrochloride 2 mg/mL Injectable Solution (DRUG).
Who is sponsoring clinical trial NCT03526874?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03526874's enrollment target sits among peer trials
63 1800th of 2000 higher than 199 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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