Phase 3 N=58 Randomized Double-blind Treatment

Occipital Blocks for Acute Migraine

Chronic Migraine, Headache · Episodic Migraine

Bottom Line

View on ClinicalTrials.gov: NCT03526874 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Apr 2024

Primary outcome: Primary: Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) — 2.3; 1.1 score on a scale — p=0.013

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lidocaine 4% Topical Application Cream [LMX 4] (Drug); Lidocaine Hydrochloride 2 mg/mL Injectable Solution (Drug); Normal Saline (Drug)
Age: Pediatric, Adult · 7+ yrs
Sex: All
Sponsor: Children's Hospital of Philadelphia
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS)	2.3; 1.1	0.013 sig
PRIMARY Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS)	24.97; 12.86	0.031 sig
PRIMARY Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex	2.5; 1; 2; 2	0.0162 sig
PRIMARY Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex	25.5; 12; 23.6; 10.3	0.04 sig
PRIMARY Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity	1.3; -0.5; 2.5; 1.2	0.0098 sig
PRIMARY Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity	9; -3.5; 27.5; 14.5	0.02 sig
PRIMARY Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race	0; 0; 4; 2; 2.4; 0.8	0.01 sig
PRIMARY Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race	-12; 3; 26; 21.3; 27.2; 10	0.0329 sig
SECONDARY Change From Baseline Disability	0.036; -13.36	0.294
SECONDARY Change From Baseline Disability to Day 7	5.78; 2.11	0.058
SECONDARY Change From Baseline Disability to Week 4	5.05; 2.06	0.182
SECONDARY Percentage of Subjects With Pain Freedom	5; 2	0.423
SECONDARY Percentage of Subjects With Pain Relief or Headache Response	15; 7	0.030 sig
SECONDARY Percentage of Subjects With Sustained Pain Freedom	4; 0	0.112
SECONDARY Percentage of Subjects With Sustained Pain Relief	7; 1	0.052
SECONDARY Percentage of Subjects With Freedom From All Symptoms of Migraine	14; 6	0.027 sig

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.

Eligibility Criteria

Inclusion Criteria

Children / Adolescents:
Males or females, ages 7 - 21, of any gender, race, or ethnicity
Diagnosis of episodic or chronic migraine with acute headache flare lasting up to 3 months unresponsive to acute medications. Patients who report that acute medications were not used during this headache flare because those medications have been ineffective for several prior headache flares will be included
Informed parental consent and subject assent
Girls, who have reached menarche, must have a negative urine or serum pregnancy test
Weight > 25kg
Parents:
Parents or guardians of children enrolled, who speak either English or Spanish, and provide parental/guardian permission (informed consent) for their own participation
Subject (child) assent

Exclusion Criteria

Children / Adolescents:
Previous nerve block less than 3 months ago or more than 2 previous nerve blocks
Allergy to local anesthetics
Skull defect or break in the skin at the planned site of cream application or GON injection
Any investigational drug use within 30 days prior to enrollment, or 90 days prior to enrollment for medications targeted at Calcitonin Gene-Related Peptide
Pregnant or lactating females
Parents/guardians or subjects who, in the opinion of the Investigator, may be non- compliant with study schedules or procedures
Significant adverse event with prior injection or procedure
New abnormalities on physical or neurological examination
Newly reported red flags in headache history which prompt investigation for secondary headache
Non-English and Non-Spanish speaking
Non-English speaking with no Spanish interpreter available
Parents:
Parents or guardians of children enrolled, who do not speak either English or Spanish
Parental/guardian permission and/or subject (child) assent has been declined
Parents or guardians, who in the opinion of the investigator, may be non-compliant or unable to complete the questionnaires

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03526874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.