Treatment for Sick Headache

Phase-Based Estimates
1
Effectiveness
1
Safety
ClinVest Research, Springfield, MO
Sick Headache+1 More
Eligibility
18+
All Sexes
Eligible conditions
Sick Headache

Study Summary

Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention

See full description

Eligible Conditions

  • Sick Headache
  • Migraine Disorders
  • Migraine

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 3 primary outcomes, 6 secondary outcomes, and 6 other outcomes in patients with Sick Headache. Measurement will happen over the course of 2 hours post treatment at follow up phase.

12 weeks
Health economic analysis
Hour 2
Percentage of freedom from headache post 2 hours following prodrome treatment
Hour 24
Percentage of freedom from headache post 24 hours following prodrome treatment
Percentage of reduction of headache post 24 hours from prodrome treatment
3 months
Feasibility of migraine prediction algorithm
Rate of Adverse events (Safety and Tolerability)
Reduction headache days
Reduction in HIT score
Reduction in MSQ score
Reduction in headache days
Reduction in migraine days
Reduction in migraine medication intake
Reduction in moderate/severe headache days
Reduction of 30% in headache days
Reduction of 50% in headache days

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Migraine prevention treatment with sham Nerivio
Placebo group

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 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 not being studied for commercial purposes.

Migraine prevention treatment with sham Nerivio
Device
Participants will treat with a sham (placebo) Nerivio device every other day for migraine prevention.
Migraine prevention treatment with active Nerivio
Device
Participants will treat with an active Nerivio device every other day for migraine prevention.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months for reporting.

Closest Location

ClinVest Research - Springfield, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18-75 years old.
Must have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic (at least 15 days of HA/ month with migraine days (migraine with and without aura) at least 8 days/ month for > 3 months) or non-chronic migraine.
History of 6 to 24 headache days per 28-day period for each of the 3 months preceding study enrolment (based on participant report).
Subject on prophylactic migraine treatment are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 2 months prior to the screening visit, and the dose is not expected to change during the course of the study.
Have personal access to a smartphone (24/7).
Must be able and willing to comply with the protocol.
Must be able and willing to provide informed consent..

Patient Q&A Section

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

Can sick headache be cured?

Add answer

Many sick headache patients are able to control their symptoms with an appropriate medication regimen. This has positive implications for the self-management of chronic pain, including sick headache.

Unverified Answer

What are common treatments for sick headache?

Add answer

Most (about 70%) adults with sick headache will have a headache at some time during the year. Most people (60%) would take either medication that can help with the headache (drugs and nonpharmacological treatments); the others (about 40%) would not use any type of medication. Among those who use medication, about half (about 50%) would try it a lot, about 20% would read the package insert, and about 40% would try it once they had taken the first dose.

Unverified Answer

What causes sick headache?

Add answer

Sick headache occurs because the brain's pain centers have dysfunctional pain processing. However, the cause is not always clearly identified. It is common at episodic intervals with a mild to moderate intensity. There may be an increased chance of sick headache following exposure to viral, bacterial, or parasitic agents. Sick headache may have a psychological component; some individuals suffering sick headache report low coping abilities.

Unverified Answer

What are the signs of sick headache?

Add answer

This patient's course is probably due to an acute infection or a neoplasm. Her initial presentation is highly suggestive of meningitis, but an alternative cause of headache should also be considered, such as infection or sinusitis.

Unverified Answer

What is sick headache?

Add answer

Sick headache is an intense, episodic headache syndrome characterized by severity, duration, relief, impact on activities and disability. It is one of the most common chronic headache syndromes, affecting 2-3% of the US population. Different groups are more likely to have chronic, debilitating headache conditions such as sick headache. However, the majority of individuals with sick headache will experience significant improvements in their symptoms following treatment. Sick headache can have a variety of causes. Identification of the cause of a chronic headache such as sick headache is key to determining its etiology and therapeutic options.

Unverified Answer

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

Add answer

In total, 8.6 million Americans are treated for episodic or persistent sick headache a year. In the United Kingdom, 8.8 million people have episodic or persistent sick headache a year. The number of people with episodic, persistent, or chronic sick headache per physician in the United States was 4.5 times higher than in the United Kingdom. This difference is likely related to the higher degree of access to medical practitioners and resources in the United States than in the United Kingdom.

Unverified Answer

Does sick headache run in families?

Add answer

In a recent study, findings suggests that there might be a genetic basis for sick headache, but further studies with larger sample sizes are required.

Unverified Answer

Is treatment typically used in combination with any other treatments?

Add answer

A combination of different treatments is used in less than 10% of patients with chronic migraine. However, this was reported by only 2% of individuals in this study.

Unverified Answer

Have there been other clinical trials involving treatment?

Add answer

To avoid duplicate investment in clinical trials, potential trial developers need to communicate with investors regarding whether the trial is part of a clinical series or a separate initiative. Such communication reduces the likelihood of the trial being seen as redundant, and may lead investors to be more willing to invest because they perceive the results will not be wasted.

Unverified Answer

How does treatment work?

Add answer

There is evidence to show that a shortcourse of a standard medication (paracetamol) can induce a significant reduction of sick headaches. Results from a recent paper is the first study reporting these results using a short course of aspirin or paracetamol. Paracetamol could also be used for shortcourse treatment of migraine or tension headaches and may be used in the prophylactic treatment of recurrent headache attacks. More research could be required to show better evidence. Paracetamol could be used for shortcourse treatment of sick headache of unclear or unknown origin. Paracetamol could be used for shortcourse correction of sick headache in teenagers.

Unverified Answer

What are the common side effects of treatment?

Add answer

For many side effects, no clear differences were found regarding the presence or absence of a side effect or between the different groups. However, our data indicates that there are small differences.

Unverified Answer

What is the average age someone gets sick headache?

Add answer

Median age at onset is 27.6 years. Most (93.9 %) patients are younger than 50 years old. Female patients were somewhat older and more likely to have multiple bouts of headache over the last three months.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Sick Headache by sharing your contact details with the study coordinator.