Chronic Migraine, HeadachePhase 3NCT03526874
Occipital Blocks for Acute Migraine
A Phase 3 study testing Lidocaine 4% Topical Application Cream [LMX 4], Lidocaine Hydrochloride 2 mg/mL Injectable Solution and Normal Saline in people with Chronic Migraine, Headache and Episodic Migraine, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Chronic Migraine, Headache, Episodic Migraine
- What is being tested?
- Lidocaine 4% Topical Application Cream [LMX 4], Lidocaine Hydrochloride 2 mg/mL Injectable Solution and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2019to 10 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Occipital Nerve Blocks for Acute Treatment of Pediatric 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 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.
Read the detailed description
There are two substantial hurdles that must be overcome in designing a trial to test the efficacy of PNBs: high placebo response rate and possible unblinding. In order to test the efficacy of this commonly used treatment for children and adolescents with difficult-to-treat headache, we need utilize a trial design which will address the high placebo response rate and the potential lack of blinding.
About 194 children, recruited over a 3.5 year period at Children's Hospital of Philadelphia, will take part in this study. Participation will last about one month and involve one in-person study visit, and then completion of headache-related surveys, at home, for 28 days. Lidocaine cream lead-in will be used open-label for all subjects followed by double-blind randomized injections of active treatment (lidocaine) versus comparator (saline) in subjects who continue to have significant headache.
To accomplish our secondary objectives, we will examine how expectation is affected by perceived treatment, and how expectations, measured in patients, parents, and providers, influence outcomes in pediatric and adolescent acute migraine.
- Conditions
- Chronic Migraine, Headache, Episodic Migraine
- Being tested
- Lidocaine 4% Topical Application Cream [LMX 4], Lidocaine Hydrochloride 2 mg/mL Injectable Solution, Normal Saline
- Keywords
- Pain, Chronic Migraine, Episodic Migraine, Headache, Nerve Block
- Medical subject headings
- Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 4% Topical Application Cream [LMX 4]Drug
Run-in Step: All subjects receive 32 mg (4 cm ribbon of cream) applied, bilaterally, over greater occipital nerve.
Lidocaine Hydrochloride 2 mg/mL Injectable SolutionDrug
Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment.
Normal SalineDrug
Also called 0.9% Sodium Chloride
Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator.
| Study group | Role | What they receive |
|---|---|---|
| Greater Occipital Nerve (GON) Block with Lidocaine | Experimental | Subjects randomized to this arm receive 2 mL injection of lidocaine 2% over the right and left greater occipital nerve at the baseline study visit.
All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days. Receives: Drug: Lidocaine 4% Topical Application Cream [LMX 4]; Drug: Lidocaine Hydrochloride 2 mg/mL Injectable Solution |
| Greater Occipital Nerve (GON) Block with Saline | Placebo comparator | Subjects randomized to this arm receive 2 mL injection of preservative-free normal saline over the right and left greater occipital nerve at the baseline study visit.
All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days. Receives: Drug: Lidocaine 4% Topical Application Cream [LMX 4]; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS)
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.
Measured: Pre-injection (*Baseline*) and 30 minutes Post-injection
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS)
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Measured: Pre-injection and 30 minutes Post-injection
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex
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. By sex. 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.
Measured: Pre-injection (*Baseline*) and 30 minutes Post-injection
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By sex. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Measured: Pre-injection and 30 minutes Post-injection
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity
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. By ethnicity. 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.
Measured: Pre-injection (*Baseline*) and 30 minutes Post-injection
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By ethnicity. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Measured: Pre-injection and 30 minutes Post-injection
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race
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. By race. 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.
Measured: Pre-injection (*Baseline*) and 30 minutes Post-injection
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By race. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Measured: score on a scale
Secondary outcomes (8)
Change From Baseline Disability
The PedMIDAS will assess changes in functional disability due to headache. The PedMIDAS is a validated 6-question scale that captures headache-related disability-across multiple domains of functioning including school, home, social, and recreational-for pediatric and adolescent aged patients over 3 months. The instrument measures the number of days in which subjects missed activities due to headache or migraine. The measure yields a total score by summing items ranging from 0 to 90 day. The higher the score the higher the disability. Change in total score (total at week 4 minus total at baseline) is reported.
Measured: Baseline and Week 4
Change From Baseline Disability to Day 7
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (Short Form) will assess changes in functional disability due to headache. The PROMIS Pain Interference (Short Form) measures the self-reported consequences of pain on relevant aspects of the subject's life over the past seven days. A pain item pool was developed to yield scores on a T-score scale with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more pain interference, a T-score of 60 is one standard deviation (SD) worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.
Measured: Baseline and Day 7
Change From Baseline Disability to Week 4
The PROMIS Pain Interference (Short Form) will assess changes in functional disability due to headache. The PROMIS Pain Interference (Short Form) measures the self-reported consequences of pain on relevant aspects of the subject's life over the past seven days. A pain item pool was developed to yield scores on a T-score scale with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.
Measured: Baseline and Week 4
Percentage of Subjects With Pain Freedom
The measurement involves resolution of headache pain within 30 minutes after injection and prior to any rescue medications. Data will be collected prospectively from subjects, at the study visit.
Measured: 30 minutes Post-injection
Percentage of Subjects With Pain Relief or Headache Response
The measurement involves improvement in headache from "severe or moderate" to "none or mild" within 30 minutes and before any rescue medications. Data will be collected prospectively from subjects at the study visit.
Measured: 30 minutes Post-injection
Percentage of Subjects With Sustained Pain Freedom
The measurement involves being pain-free within 30 minutes and lasting at least 24 hours, with no use of rescue medication and no relapse or recurrence. Data will be collected prospectively from subjects, via text, in an electronic headache diary.
Measured: 24 hours Post-injection
Percentage of Subjects With Sustained Pain Relief
The measurement involves having pain-relief within 30 minutes and lasting at least 24 hours, with no use of rescue medication and no relapse or recurrence. Data will be collected prospectively from subjects, via text, in an electronic headache diary.
Measured: 24 hours Post-injection
Percentage of Subjects With Freedom From All Symptoms of Migraine
The presence or absence of photophobia, phonophobia, and nausea will be collected from subjects prospectively, via text, in an electronic headache diary.
Measured: 24 hours Post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start3 Apr 2019
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Migraine, HeadacheStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind greater occipital nerve injection of lidocaine versus saline after open-label lidocaine cream run-in
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina L. Szperka, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526874
- Sponsor's protocol ID
- 18-014939
- Other IDs
- K23NS102521
- Status last verified
- Mar 2025
- First submitted
- 4 May 2018
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hershey AD, Powers SW, Vockell AL, LeCates S, Kabbouche MA, Maynard MK. PedMIDAS: development of a questionnaire to assess disability of migraines in children. Neurology. 2001 Dec 11;57(11):2034-9. doi: 10.1212/wnl.57.11.2034.
PubMed 11739822Powers SW, Patton SR, Hommel KA, Hershey AD. Quality of life in childhood migraines: clinical impact and comparison to other chronic illnesses. Pediatrics. 2003 Jul;112(1 Pt 1):e1-5. doi: 10.1542/peds.112.1.e1.
PubMed 12837897Split W, Neuman W. Epidemiology of migraine among students from randomly selected secondary schools in Lodz. Headache. 1999 Jul-Aug;39(7):494-501. doi: 10.1046/j.1526-4610.1999.3907494.x.
PubMed 11279934Abu-Arefeh I, Russell G. Prevalence of headache and migraine in schoolchildren. BMJ. 1994 Sep 24;309(6957):765-9. doi: 10.1136/bmj.309.6957.765.
PubMed 7950559Szperka CL, Gelfand AA, Hershey AD. Patterns of Use of Peripheral Nerve Blocks and Trigger Point Injections for Pediatric Headache: Results of a Survey of the American Headache Society Pediatric and Adolescent Section. Headache. 2016 Nov;56(10):1597-1607. doi: 10.1111/head.12939. Epub 2016 Oct 12.
PubMed 27731894Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
PubMed 20554116Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.
PubMed 22384463
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occipital Nerve Blocks for Acute Treatment of Pediatric Migraine
- ClinicalTrials.gov ID
- NCT03526874
- Acronym / sponsor ID
- 18-014939
- Conditions
- Chronic Migraine, Headache, Episodic Migraine
- Keywords
- Pain, Chronic Migraine, Episodic Migraine, Headache, Nerve Block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Posted 30 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are two substantial hurdles that must be overcome in designing a trial to test the efficacy of PNBs: high placebo response rate and possible unblinding. In order to test the efficacy of this commonly used treatment for children and adolescents with difficult-to-treat headache, we need utilize a trial design which will address the high placebo response rate and the potential lack of blinding.
About 194 children, recruited over a 3.5 year period at Children's Hospital of Philadelphia, will take part in this study. Participation will last about one month and involve one in-person study visit, and then completion of headache-related surveys, at home, for 28 days. Lidocaine cream lead-in will be used open-label for all subjects followed by double-blind randomized injections of active treatment (lidocaine) versus comparator (saline) in subjects who continue to have significant headache.
To accomplish our secondary objectives, we will examine how expectation is affected by perceived treatment, and how expectations, measured in patients, parents, and providers, influence outcomes in pediatric and adolescent acute migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind greater occipital nerve injection of lidocaine versus saline after open-label lidocaine cream run-in
| Arm | Type | Receives |
|---|---|---|
| Greater Occipital Nerve (GON) Block with Lidocaine | Experimental | Drug: Lidocaine 4% Topical Application Cream [LMX 4], Drug: Lidocaine Hydrochloride 2 mg/mL Injectable SolutionSubjects randomized to this arm receive 2 mL injection of lidocaine 2% over the right and left greater occipital nerve at the baseline study visit. All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days. |
| Greater Occipital Nerve (GON) Block with Saline | Placebo comparator | Drug: Lidocaine 4% Topical Application Cream [LMX 4], Drug: Normal SalineSubjects randomized to this arm receive 2 mL injection of preservative-free normal saline over the right and left greater occipital nerve at the baseline study visit. All subjects then complete daily headache-related questions through a Headache Diary and other assessments for 28 days. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Children / Adolescents:
- Parents:
Key exclusion criteria (16 listed)
- Children / Adolescents:
- Parents:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 4% Topical Application Cream [LMX 4]Run-in Step: All subjects receive 32 mg (4 cm ribbon of cream) applied, bilaterally, over greater occipital nerve. | Drug | Greater Occipital Nerve (GON) Block with Lidocaine, Greater Occipital Nerve (GON) Block with Saline |
| Lidocaine Hydrochloride 2 mg/mL Injectable SolutionSubjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment. | Drug | Greater Occipital Nerve (GON) Block with Lidocaine |
| Normal SalineAlso: 0.9% Sodium ChlorideSubjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator. | Drug | Greater Occipital Nerve (GON) Block with Saline |
Primary outcome
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS)
Time frame: Pre-injection (*Baseline*) and 30 minutes Post-injection
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.
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS)
Time frame: Pre-injection and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Sex
Time frame: Pre-injection (*Baseline*) and 30 minutes Post-injection
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. By sex. 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.
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Sex
Time frame: Pre-injection and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By sex. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Ethnicity
Time frame: Pre-injection (*Baseline*) and 30 minutes Post-injection
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. By ethnicity. 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.
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Ethnicity
Time frame: Pre-injection and 30 minutes Post-injection
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By ethnicity. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) by Race
Time frame: Pre-injection (*Baseline*) and 30 minutes Post-injection
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. By race. 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.
Mean Change in Pain Intensity Scores Measured by the Visual Analog Scale (VAS) by Race
Time frame: score on a scale
By subtracting the 30 minutes post-injection score from the pre-injection score, measured on a Visual Analog Scale (VAS), the mean change, in the lidocaine versus saline groups, will be used as the primary outcome measure. By race. VAS scale is a 0 to 100 visual scale, with 0 meaning no pain and 100 meaning "the worse pain imaginable".
8 secondary outcomes
Change From Baseline Disability
Time frame: Baseline and Week 4
Change From Baseline Disability to Day 7
Time frame: Baseline and Day 7
Change From Baseline Disability to Week 4
Time frame: Baseline and Week 4
Percentage of Subjects With Pain Freedom
Time frame: 30 minutes Post-injection
Percentage of Subjects With Pain Relief or Headache Response
Time frame: 30 minutes Post-injection
Percentage of Subjects With Sustained Pain Freedom
Time frame: 24 hours Post-injection
Percentage of Subjects With Sustained Pain Relief
Time frame: 24 hours Post-injection
Percentage of Subjects With Freedom From All Symptoms of Migraine
Time frame: 24 hours Post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11739822Hershey AD, Powers SW, Vockell AL, LeCates S, Kabbouche MA, Maynard MK. PedMIDAS: development of a questionnaire to assess disability of migraines in children. Neurology. 2001 Dec 11;57(11):2034-9. doi: 10.1212/wnl.57.11.2034.
- Background: PubMed 12837897Powers SW, Patton SR, Hommel KA, Hershey AD. Quality of life in childhood migraines: clinical impact and comparison to other chronic illnesses. Pediatrics. 2003 Jul;112(1 Pt 1):e1-5. doi: 10.1542/peds.112.1.e1.
- Background: PubMed 11279934Split W, Neuman W. Epidemiology of migraine among students from randomly selected secondary schools in Lodz. Headache. 1999 Jul-Aug;39(7):494-501. doi: 10.1046/j.1526-4610.1999.3907494.x.
- Background: PubMed 7950559Abu-Arefeh I, Russell G. Prevalence of headache and migraine in schoolchildren. BMJ. 1994 Sep 24;309(6957):765-9. doi: 10.1136/bmj.309.6957.765.
- Background: PubMed 27731894Szperka CL, Gelfand AA, Hershey AD. Patterns of Use of Peripheral Nerve Blocks and Trigger Point Injections for Pediatric Headache: Results of a Survey of the American Headache Society Pediatric and Adolescent Section. Headache. 2016 Nov;56(10):1597-1607. doi: 10.1111/head.12939. Epub 2016 Oct 12.
- Background: PubMed 20554116Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
- Background: PubMed 22384463Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina L. Szperka, MD, MSCE principal investigator
Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine 4% Topical Application Cream [LMX 4], Lidocaine Hydrochloride 2 mg/mL Injectable Solution and Normal Saline in people with Chronic Migraine, Headache and Episodic Migraine, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Pain Intensity Scores Measured by the Numeric Analog Scale (NRS) (time frame: Pre-injection (*Baseline*) and 30 minutes Post-injection). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03526874, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.