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Occipital Blocks for Acute Migraine

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ClinicalTrials.gov Identifier: NCT03526874
Recruitment Status : Not yet recruiting
First Posted : May 16, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Migraine, Headache Episodic Migraine Drug: Lidocaine 4% Topical Application Cream [LMX 4] Drug: Lidocaine Hydrochloride 2 mg/mL Injectable Solution Drug: Normal Saline Phase 3

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 58 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind greater occipital nerve injection of lidocaine versus saline after open-label lidocaine cream run-in
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Occipital Nerve Blocks for Acute Treatment of Pediatric Migraine
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: 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.

Drug: 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: 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.

Placebo Comparator: 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.

Drug: 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: Normal Saline
Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator.
Other Name: 0.9% Sodium Chloride




Primary Outcome Measures :
  1. Mean Change in Pain Intensity Scores [ 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. A mean change of 2-points has been shown to be clinically relevant.


Secondary Outcome Measures :
  1. Change from Baseline Disability [ Time Frame: Baseline and Day 7 ]
    The PROMIS Pain Interference (Short Form) as well as the PedMIDAS 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. 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. Total scores correspond to one of four disability grades: 0 - 10 = little to no disability; 11-30 = mild disability; 31-50 = moderate disability; and > 50 = severe disability.

  2. Percentage of Subjects with Pain Freedom [ Time Frame: 2 hours Post-injection ]
    The measurement involves resolution of headache pain within 2 hours after injection and prior to any rescue medications. Data will be collected prospectively from subjects, via text, in an electronic headache diary.

  3. Percentage of Subjects with Pain Relief or Headache Response [ Time Frame: 2 hours Post-injection ]
    The measurement involves improvement in headache from "severe or moderate" to "none or mild" within 2 hours and before any rescue medications. Data will be collected prospectively from subjects, via text, in an electronic headache diary.

  4. Percentage of Subjects with Sustained Pain Freedom and Relief [ Time Frame: 24 hours Post-injection ]
    The measurement involves being pain-free within 2-hours 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.

  5. Percentage of Subjects with Freedom from all symptoms of migraine [ Time Frame: 24 hours Post-injection ]
    The presence or absence of photophobia, phonophobia, and nausea will be collected from subjects prospectively, via text, in an electronic headache diary.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children / Adolescents:

    • Males or females, ages 7 - 17, of any gender, race, or ethnicity
    • Diagnosis of episodic or chronic migraine with acute headache flare lasting 24 hours to 4 weeks unresponsive to acute oral and/or nasal 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
    • Allergy to local anesthetics
    • Skull defect or break in the skin at the planned site of cream application or GON injection
    • Use of IV medications to treat current headache flare prior to enrollment
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526874


Contacts
Contact: Christina L. Szperka, MD, MSCE 215-590-1719 szperka@email.chop.edu
Contact: Dana M. Haagen, BA, BS haagend@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christina L. Szperka, MD, MSCE    215-590-1719      
Principal Investigator: Christina L. Szperka, MD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Christina L. Szperka, MD, MSCE Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:
Informed Consent Form  [PDF] April 20, 2018


Publications:

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03526874     History of Changes
Other Study ID Numbers: 18-014939
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Children's Hospital of Philadelphia:
Pain
Chronic Migraine
Episodic Migraine
Headache
Nerve Block

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action