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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 is a Phase 3 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03526874
The ClinicalTrials.gov registry entry for NCT03526874 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Normal Saline is the first listed.
NCT03526874 reports 0 study locations.
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.
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