CLINICAL TRIAL

Qudexy XR for Sick Headache

Recruiting · < 18 · All Sexes · Springfield, OR

This study is evaluating whether a medication may help prevent migraines in children.

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About the trial for Sick Headache

Treatment Groups

This trial involves 2 different treatments. Qudexy XR 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 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Qudexy XR
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The subject has had at least six months of headaches that are consistent with the diagnosis of migraine with or without aura, according to the International Classification of Headache Disorders, Third Edition. show original
The subject weighs more than 17.0 kg and less than 50.0 kg at the first visit show original
The subject has a PedMIDAS score of greater than 10, indicating that the subject's daily activities are mildly disrupted, and a PedMIDAS score of less than 140, indicating that the subject's daily activities are extremely disrupted and may require more comprehensive, multi-component therapy. show original
The subject is a female or male who is between the ages of 6 and 11, inclusive, at the time of their first visit. show original
The subject had at least eight headache days in the previous month. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 16 Weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 16 Weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Qudexy XR will improve 1 primary outcome in patients with Sick Headache. Measurement will happen over the course of 16 Weeks.

Change from Baseline (last 28 days Run-In Period) in the monthly number of headache days during the 8-week Maintenance Period based on the diary.
16 WEEKS

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?

Although the effect of treatment in this study did not correspond directly to the subjective improvement, the study results support the possibility of a successful treatment of sick headache. Further, the study findings can be used as a basis for considering more individual therapy options.

Anonymous Patient Answer

What is sick headache?

Although sick headache can present with a wide range of symptoms, the most common presenting complaint is headache. Atypical headache characteristics such as nausea/vomiting, dysphagia, dysarthria, dysphasia and syncope have predictive value for cerebral and/or intracranial lesions in head CT. Clinicians can use this information to accurately and quickly rule out intracranial pathology that may be responsible for such symptoms.

Anonymous Patient Answer

What are the signs of sick headache?

Sick headache is a common phenomenon in primary care and it is common to seek medical advice only when it is severe or lasts longer than three days. Primary care should be familiar with the symptoms and signs of sick headache as they will help them to formulate a differential diagnosis.

Anonymous Patient Answer

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

About 7.6 million, or 27%, of the American population has at least one reported case of sickness headache in a given year. More than 1.7 million adults (10%) are affected by sickness headache at least a few times every year. About 75,000-110,000 persons seek medical care for sickness headache each year. As a group, adults without health insurance are more likely to suffer from sickness headache, but a large part of the variation in prevalence is attributable to differences in age, sex and race/ethnicity. A history of a head trauma was associated with an increased risk in only 2 of 6 subgroups.

Anonymous Patient Answer

What causes sick headache?

Sick headache is frequently associated with other medical or psychiatric problems. Patients should be approached for these potential interactions to formulate a diagnosis and management plan. The diagnosis of sick headache is difficult for two reasons. First, typical manifestations of sick headache are often overshadowed by the myriad of psychiatric and neurologic problems present in a substantial number of patients. Furthermore, an acute headache with focal deficit may also signify different, and potentially life-threatening, pathologies such as brain stem compression, a cerebral hemorrhage, or intracranial mass. More study is needed to better quantify the prevalence, etiology, and effects of sick headaches in the general population.

Anonymous Patient Answer

What are common treatments for sick headache?

Results from a recent clinical trial of this study indicate that only the treatment for migraine is effective in reducing both the frequency and the painfulness of attacks.

Anonymous Patient Answer

What is qudexy xr?

Qudexy/Xr/Xs has not been used for headache, dizziness, or vision problems before. The FDA said the drug could cause serious heart and lung problems and should be used carefully. The label warns that it can cause dizziness, confusion, and ataxia, as well as heart palpitations, chest pains, shortness of breath, and swelling of the hands and feet. In addition, the label also warns that patients who already have heart problems may suffer further impairment and that women who are pregnant should not take the drug because of its potential for harm to their children.

Anonymous Patient Answer

What is the primary cause of sick headache?

In most patients with sick headaches, there seems to be a single primary headache disorder. We suggest that the most prevalent primary headache disorder is episodic tension-type headache. Once a diagnosis of primary headaches becomes known, physicians need to be aware of [sickle cell disease, vasculitis, sarcoidosis, fibromyalgia, and rheumatoid arthritis or spondyloarthritis] as possible secondary causes of sick headache.

Anonymous Patient Answer

Is qudexy xr typically used in combination with any other treatments?

Results from a recent clinical trial, qudexy XR was typically used in combination with aspirin which is frequently used for the prophylaxis of secondary headache. Results from a recent clinical trial has only a small sample size and the results need to be verified in additional patient numbers.

Anonymous Patient Answer

What is the average age someone gets sick headache?

The average age of sih headache is 20 years. Older patients are reported to be more likely to present headache than younger patients. There is a wide demographic variability in the prevalence of sih headache according to age class and sex. There is no significant difference of sih headache on the basis of ethnicity. Age is the most important factor affecting the condition.

Anonymous Patient Answer

Is qudexy xr safe for people?

In the absence of compelling indications, qudexy xr is not recommended for the routine use in people, because most adults who receive qudexy xr develop clinically significant symptoms, usually within the first twelve weeks.

Anonymous Patient Answer
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