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| ID | Type | Description | Link |
|---|---|---|---|
| K23NS102521 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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". | 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. | 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Children / Adolescents:
Parents:
Exclusion Criteria:
Children / Adolescents:
Parents:
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| Name | Affiliation | Role |
|---|---|---|
| Christina L. Szperka, MD, MSCE | Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11739822 | Background | 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. | |
| 12837897 | Background | Powers 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. |
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Lidocaine cream lead in. If the subject responded to lidocaine cream application after 30 minutes they were not randomized. All eligible subjects were randomized.
Subjects were contacted over the phone and, if interested, verbally consented and prescreened. Potentially eligible subjects were schedule for a visit. After signing consent during the study visit, eligibility was assessed. Approximately 438 patients were prescreened, and we have approached 140. Of those 63 were recruited and 58 randomized (5 screen failed after consent)).
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| ID | Title | Description |
|---|---|---|
| FG000 | Greater Occipital Nerve (GON) Block With Lidocaine | 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. 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. Lidocaine Hydrochloride 2 mg/mL Injectable Solution: Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment. |
| FG001 | Greater Occipital Nerve (GON) Block With Saline | 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. 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. Normal Saline: Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Greater Occipital Nerve (GON) Block With Lidocaine | 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. 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. Lidocaine Hydrochloride 2 mg/mL Injectable Solution: Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | score on a scale | Pre-injection (*Baseline*) and 30 minutes Post-injection |
|
Adverse events (AEs) were collected from the time of the lead in treatment (lidocaine cream) application until 28days post-visit, up to 29 days.
AEs were collected by RedCap survey, contact with the family and Epic chart review up until 28 days post visit. Serious adverse events (SAEs) were reported to the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) within 24h of knowledge of the event. AEs were reported to the IRB at the next continuing review.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Greater Occipital Nerve (GON) Block With Lidocaine | 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. 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. Lidocaine Hydrochloride 2 mg/mL Injectable Solution: Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis | Immune system disorders | Systematic Assessment | Participant reported insufficient relief after study nerve block. After nerve block with open-label lidocaine she developed symptoms of anaphylaxis, and was treated with epinephrine and albuterol. She was observed in the ED and symptoms resolved. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pre-syncope/syncope | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Szperka | Children's Hospital of Philadelphia | 12155901719 | szperka@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2022 | Mar 1, 2024 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2021 | May 10, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Randomized, double-blind greater occipital nerve injection of lidocaine versus saline after open-label lidocaine cream run-in
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| Lidocaine Hydrochloride 2 mg/mL Injectable Solution | Drug | Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment. |
|
| Normal Saline | Drug | Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator. |
|
|
| 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. | 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". | 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. | 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". | score on a scale |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 hours Post-injection |
| 11279934 | Background | Split 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. |
| 7950559 | Background | Abu-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. |
| 27731894 | Background | Szperka 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. |
| 20554116 | Background | Amtmann 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. |
| 22384463 | Background | Tfelt-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. |
| BG001 | Greater Occipital Nerve (GON) Block With Saline | 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. 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. Normal Saline: Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Participants' self-representation of gender identity | Count of Participants | Participants |
|
| Sex: Female, Male | Participants' classification as male or female based on biological distinctions | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Migraine Diagnosis | Count of Participants | Participants |
|
| OG001 | Greater Occipital Nerve (GON) Block With Saline | 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. 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. Normal Saline: Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator. |
|
|
|
| Primary | 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". | Posted | Mean | Standard Error | score on a scale | Pre-injection and 30 minutes Post-injection |
|
|
|
|
| Primary | 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. | Overall number is divided between the different sex subcategories for analysis. | Posted | Mean | Standard Deviation | score on a scale | Pre-injection (*Baseline*) and 30 minutes Post-injection |
|
|
|
|
| Primary | 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". | Overall number is divided between the different sex subcategories for analysis. | Posted | Mean | Standard Deviation | score on a scale | Pre-injection and 30 minutes Post-injection |
|
|
|
|
| Primary | 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. | Overall number is divided between the different ethnic subcategories for analysis. | Posted | Mean | Standard Deviation | score on a scale | Pre-injection (*Baseline*) and 30 minutes Post-injection |
|
|
|
|
| Primary | 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". | Overall number is divided between the different ethnic subcategories for analysis. | Posted | Mean | Standard Deviation | score on a scale | Pre-injection and 30 minutes Post-injection |
|
|
|
|
| Primary | 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. | Overall number is divided between the different race subcategories for analysis. | Posted | Mean | Standard Deviation | score on a scale | Pre-injection (*Baseline*) and 30 minutes Post-injection |
|
|
|
|
| Primary | 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". | Overall number is divided between the different race subcategories for analysis. | Posted | Mean | Standard Deviation | score on a scale | score on a scale |
|
|
|
|
| Secondary | 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. | Missing values were omitted from testing. | Posted | Mean | Standard Error | change of score on a scale | Baseline and Week 4 |
|
|
|
|
| Secondary | 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. | Missing values were omitted from testing. | Posted | Mean | Standard Error | t-score | Baseline and Day 7 |
|
|
|
|
| Secondary | 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. | Missing values were omitted from testing. | Posted | Mean | Standard Error | T-score | Baseline and Week 4 |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 minutes Post-injection |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 minutes Post-injection |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 24 hours Post-injection |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 24 hours Post-injection |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 24 hours Post-injection |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 29 |
| 29 |
| EG001 | Greater Occipital Nerve (GON) Block With Saline | 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. 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. Normal Saline: Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator. | 0 | 29 | 1 | 29 | 28 | 29 |
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| Confusion | Nervous system disorders | Systematic Assessment |
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| Worse headache pain | Nervous system disorders | Systematic Assessment |
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| Feeling dizzy | Nervous system disorders | Systematic Assessment |
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| Feeling sick to your stomach | Gastrointestinal disorders | Systematic Assessment |
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| Feeling worried or panicky | Nervous system disorders | Systematic Assessment |
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| Numbness | Nervous system disorders | Systematic Assessment |
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| Rash | Immune system disorders | Systematic Assessment |
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| Injection site problems | Injury, poisoning and procedural complications | Systematic Assessment |
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Not provided
Not provided
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Male |
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| Male |
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| Non-Hispanic |
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| Non-Hispanic |
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| Black |
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| White |
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| Multiple races |
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| Black |
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| White |
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| Multiple races |
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