Erenumab Dose 3 for Sick Headache

Phase-Based Estimates
2
Effectiveness
3
Safety
Tominaga Hospital, Osaka-shi, Japan
Sick Headache+1 More
Erenumab Dose 3 - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Sick Headache

Study Summary

This study is evaluating whether a drug may help reduce the number of migraine headaches in children and adolescents.

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Eligible Conditions

  • Sick Headache
  • Migraine Disorders
  • Migraine

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Erenumab Dose 3 will improve 1 primary outcome and 6 secondary outcomes in patients with Sick Headache. Measurement will happen over the course of Completion of double blind treatment phase at 12 weeks.

Week 12
Change from baseline in migraine-related disability and productivity
Change from baseline in monthly migraine days (MMDs)
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
Change in monthly headache days from baseline
Change in monthly migraine days (MMDs) from baseline to the average of the first 3 months
Proportion of subjects with at least 50% reduction in monthly migraine days (MMDs) from baseline
Week 24
Change in monthly migraine days (MMDs) from baseline to the average of the first 6 month

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

3 Treatment Groups

Placebo
Dose level 2
Placebo group

This trial requires 456 total participants across 3 different treatment groups

This trial involves 3 different treatments. Erenumab Dose 3 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Dose level 2Subjects will be randomized to one of two doses determined by their body weight at Day 1.
Dose level 1Subjects will be randomized to one of two doses determined by their body weight at Day 1.
Placebo
Other
Subjects will be randomized to a placebo comparator.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: completion of double blind treatment phase at 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly completion of double blind treatment phase at 24 weeks for reporting.

Closest Location

Ann and Robert H Lurie Childrens Hospital of Chicago - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study.
Subject's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures.
History of migraine (with or without aura) for greater than or equal to 12 months before screeningaccording to the IHS Classification ICHD-3 (Headache Classification Committeeof the International Headache Society, 2013) based on medical records and/or subject self-report or parents' or legal representative's report.
Attacks may last 2 to 72 hours.
Migraine headache is more often bilateral than in adults; unilateral pain usually emerges in late adolescence or early adult life.
Migraine headache is usually frontotemporal. Occipital headache in children is rare and calls for diagnostic caution.
A subset of otherwise typical subjects have facial location of pain, which is called 'facial migraine' in the literature; there is no evidence that these subjects form a separate subgroup of migraine subjects.
In young children, photophobia and phonophobia may be inferred from their behavior.
History of less than 15 headache days per month of which greater than or equal to 4 headache days were assessed by the subject as migraine days in each of the 3 months prior to screening (refer to Section 5.6 for definition of migraine day)
Migraine frequency: greater than or equal 4 and less than 15 migraine days based on the eDiary data during the last 28 days of the baseline phase if greater than 28 days in duration

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for sick headache?

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The most-common treatments include opioids, antimigraine drugs, antidepressants, and nonsteroidal anti-inflammatory drugs (NSAIDs). People under the age of 40 who are more severe headache-free are more likely to use medical treatments. Those with migraine are less likely to be treated for their headache.

Unverified Answer

What is sick headache?

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Despite the large prevalence of sick headache and its multifactorial causation, our patients frequently do not receive a diagnosis. We discuss the issues of diagnosis, exclusion, and therapy.

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What are the signs of sick headache?

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This article has assessed the occurrence of symptoms and signs of sick headache from the literature, as well as discussing the diagnosis based on clinical presentation. The frequency of symptoms and signs is high but in addition to being important they are also misleading and non-specific and should be carefully assessed by a practitioner while the headache remains. One sign of bad headache and the mainstay is nausea. A headache diary is a useful adjunct to history in the diagnosis of sick headache. A headache diary should list what symptoms are occurring, when they are occurring and how long they last.

Unverified Answer

How many people get sick headache a year in the United States?

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Around 20% of individuals with sick headache are found to have an underlying headache disorder on medical screening. Further screening in these patients could lead to significant reductions in inappropriate, costly, and sometimes dangerous diagnostic testing and medical consultation.

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Can sick headache be cured?

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Sick headache can be cured, which emphasizes the importance of diagnosis and effective disease treatment. In patients with sick headache, we recommend that the patients follow the treatment of [headache and dizziness, restless leg syndrome, atypical facial flushing, and low body weight] for at least six months and then switch to preventive treatment.

Unverified Answer

What causes sick headache?

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Sick headache is not only a symptom of migraine; it may be caused by inflammation, or other systemic dysfunction, of the brain. It can be treated by removing the cause with appropriate medications.\n

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Does sick headache run in families?

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Although sick headache, a recurrent headache disorder, does appear to run in family populations, the genetic mechanisms underlying this predisposition are likely to be complex.

Unverified Answer

Is erenumab dose 3 safe for people?

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Erenumab doses 3120 and 3580 μg i.v. in people with treatment-resistant or -intolerant urticaria are well tolerated and associated with no change in urticaria activity.

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Does erenumab dose 3 improve quality of life for those with sick headache?

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Findings from a recent study of this study support use of the highest dose of 60 mg of erenumab administered once every 2 weeks to treat adults with treatment-experienced chronic recurrent headache.

Unverified Answer

What is the primary cause of sick headache?

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Most of the patients with sick headache were not referred in a neurology clinic for investigation. There are many factors that influence the diagnosis of a sick headache. In order to improve the management of sick headache, it is suggested that it would be useful to train physicians and nurses in the appropriate use of basic diagnostic techniques, referral to the neurology clinic, and appropriate referral to specialized centers.

Unverified Answer

Has erenumab dose 3 proven to be more effective than a placebo?

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Erenumab 100 mg once weekly is effective and well tolerated for the treatment of chronic migraine. It has a similar efficacy to the placebo as well as an acceptable and well-tolerated safety profile throughout the therapy.

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What are the common side effects of erenumab dose 3?

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The data supporting these findings demonstrated that most subjects experienced at least 1 dose-related adverse event. The most common included headache (27%), upper respiratory tract infection (20%), fatigue (19%), nausea (9%) and injection site reactions (≥9%). A minority of patients experienced dose-related side effects that were not listed above. All side effects were mild to moderate in severity and infrequent. Symptoms of serious infections, which can be life-threatening or fatal, should be reported immediately and to the investigators so that proper precautions can be taken.

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