Treatment for Sick Headache

Phase-Based Estimates
1
Effectiveness
2
Safety
JSV Clinical Researh Study, Inc., Tampa, FL
Sick Headache+1 More
Eligibility
18+
All Sexes
Eligible conditions
Sick Headache

Study Summary

This study is evaluating whether a medication may help reduce the number of migraine days per month.

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Eligible Conditions

  • Sick Headache
  • Migraine Disorders
  • Migraine

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 13 secondary outcomes in patients with Sick Headache. Measurement will happen over the course of Week 12 of the double-blind treatment phase..

Week 12
Evaluate the safety and tolerability of zavegepant.
The frequency of ALT or AST elevations > 3x ULN, concurrently with bilirubin elevations > 2x ULN in subjects treated with zavegepent during the double-blind and open label phases.
The frequency of ALT or AST elevations > 3x ULN, concurrently with bilirubin elevations > 2x ULN in subjects treated with zavegepent.
The frequency of hepatic related adverse events.
Week 1
Efficacy of zavegepant compared to placebo with the number of subjects that had a ≥ 50% reduction from Observational Phase.
Week 9
Efficacy of zavegepant compared to placebo with the number of subjects that had a ≥ 50% reduction from baseline.
Week 1
Efficacy of zavegepant to placebo in the mean number of acute migraine specific medication days per month.
Week 1
Efficacy of zavegepant to placebo on mean reduction from Observational Phase.
Efficacy of zavegepant to placebo on mean reduction from baseline.
Week 1
Efficacy of zavegepant compared to placebo as a preventive treatment for migraine
Week 12
Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase.
Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase.
The mean change from baseline in the Migraine Disability Assessment (MIDAS).
The mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v 2.1 (MSQ) role function.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

4 Treatment Groups

BHV-3500 200mg
Placebo group

This trial requires 2900 total participants across 4 different treatment groups

This trial involves 4 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

BHV-3500 200mg
Drug
Zavegepant 200mg oral soft gel capsule.
Placebo 200mg
Drug
Matching placebo 200mg oral soft gel capsule.
BHV-3500 100mg
Drug
Zavegepant 100mg oral soft gel capsule.
Placebo 100mg
Drug
Matching placebo 100mg oral soft gel capsule.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: number of migraine days per month during weeks 1 to 4
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly number of migraine days per month during weeks 1 to 4 for reporting.

Closest Location

JSV Clinical Researh Study, Inc. - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of
Migraine attacks, on average, lasting 4 - 72 hours if untreated
You have a history of migraines before age 50. show original
At least 15 headache days per month, at least 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit. show original
Eight or more migraine days during the Observation Period
You have a minimum of 15 headache days during the Observation Period. show original
One or more non-headache days during the Observation Period
Ability to distinguish migraine attacks from tension/cluster headaches
Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.

Patient Q&A Section

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

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

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There is significant variation among states in patient encounters reported as having sick headache. These data highlight an important area for further refinement of clinical practice standards for headache disorders.

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What is sick headache?

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Common headache syndromes that occur frequently in the emergency department include headache originating from the head and neck, headache of unknown origin, and headache attributed to other causes including migraine and tension headache. Physicians must be aware of the potential for head pain to have many different causes in the acute setting and when evaluating patients with headache must consider whether their presentation is acute or chronic and whether it is episodic.

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Can sick headache be cured?

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The data of the present study demonstrated the improvement of both the somatoform symptom and symptom-specific quality of life in SWH, which is the first report on this topic.

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What are common treatments for sick headache?

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Sudden exacerbation of sick headache is most often treated with symptomatic medications at first. Treatment may be prolonged in case of medication non-response, or additional medication might be tried again. In some cases, a second medication might be used.

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What causes sick headache?

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Most patients with sick headache use a number of medications, indicating that it is a multifactorial pain. Some of these medications cause CNS effects; these effects may be mediated through vasoconstriction of the cerebrovasculature. The presence of headache in the context of multiple medications may be indicative of a CNS issue.

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What are the signs of sick headache?

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There is no doubt in the literature that pain in the neck is a very significant presenting complaint of headache. The pain must be of high severity in order to be diagnosed as serious headache. The headache must not be relieved by medications prescribed without a prescription. This is to ensure that the patient does not take the medication for relief while the headache persists. The headache must be reported to healthcare professionals as this has a very high chance of becoming a life changing disease.

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Who should consider clinical trials for sick headache?

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Although patients with headaches often seek healthcare for their headache symptoms, many also are seeking help for other associated conditions. The high rate of associated diagnoses was due to the lack of headache specialists. This finding suggests that patients with non-specific headache should consider clinical trials. Because these patients do meet the study criteria, a limited number of patients may choose these trials.

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Does treatment improve quality of life for those with sick headache?

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Treatment of sick headache does not improve HRQOL. HRQOL at baseline was most closely associated with HRQOL at 1 year, suggesting that HRQOL should be assessed at baseline and during therapy periods to ensure long-term improvement.

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What is the average age someone gets sick headache?

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Older patients (≥50 years) are more likely than younger patients (20-39 years) to perceive that their headaches are aggravated by physical activity or other causes, headache severity decreases with age, and more than one-third of older subjects had a history of a headache-related concussion. As the study population only included healthy adults, the applicability of the results to the wider population should be carefully considered.

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What are the latest developments in treatment for therapeutic use?

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The new treatments and drug development technologies in treatment of sick headache have demonstrated significant improvement to the efficacy and safety profile of existing treatment options.

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What is the primary cause of sick headache?

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The primary cause of sick headache is not clear. To facilitate discussions about possible causes amongst pediatricians and their patients, we have suggested that we incorporate the question into routine outpatient consultations and referrals to specialists. This might improve treatment options for children with sick headache and reduce unnecessary diagnostic investigations.

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What does treatment usually treat?

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There are several common types of headache that can be treated, or do not need treatment. Most headaches are not currently being addressed in treatments (at least among those seen by pediatricians, GPs, and internists), though some treatments such as migraines and cluster headaches may be addressed either partially or entirely.

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