CLINICAL TRIAL

Dihydroergotamine for Migraine without Aura

Waitlist Available · 18+ · All Sexes · Missoula, MT

This study is evaluating whether a nasal spray may help reduce the pain of migraines.

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About the trial for Migraine without Aura

Eligible Conditions
Migraine without Aura · Migraine · Migraine With Aura · Migraine Disorders · Migraine with Aura · Migraine Without Aura

Treatment Groups

This trial involves 2 different treatments. Dihydroergotamine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

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

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dihydroergotamine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
International Classification of Headache Disorder, 3rd Edition (ICHD3)
Key
Males or females, 18-65 years of age at the time of Screening Visit
Subject has at least 1-year history of migraines (with or without aura), according to the
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 12 months.
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 Dihydroergotamine will improve 1 primary outcome and 2 secondary outcomes in patients with Migraine without Aura. Measurement will happen over the course of Up to 48 hours post-dosing.

Pain Freedom
UP TO 48 HOURS POST-DOSING
Proportion of subjects free from headache pain (defined as moderate or severe headache pain becoming none on a 4-point scale)
UP TO 48 HOURS POST-DOSING
Freedom From Most-Bothersome Symptom
UP TO 48 HOURS POST-DOSING
Proportion of subjects free from most bothersome symptom (MBS) among photophobia, phonophobia and nausea
UP TO 48 HOURS POST-DOSING
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
UP TO 12 MONTHS
Incidence of adverse events, incidence of abnormal physical examination findings, abnormal 12-lead ECG readings and incidence of nasal symptoms.
UP TO 12 MONTHS

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 migraine without aura a year in the United States?

Almost two thirds of adult Americans have episodic headache. A significant proportion of those who report episodic headache present with either migraine or tension-type headache.

Anonymous Patient Answer

What are the signs of migraine without aura?

Migraine without aura (MWOA) is associated with a wide range of signs. The signs of this headache should not be underestimated even in an absence of significant episodic visual field abnormalities. Such signs should, however, be adequately understood to avoid excessive diagnostic delay and, for therapeutic and prognostic purposes, an appropriate differential diagnosis must be achieved.

Anonymous Patient Answer

What are common treatments for migraine without aura?

Current treatments for migraine without aura include the use of analgesia, anti-inflammatories and anti-epileptics. Most migraineurs require at least one medication for optimal symptom relief. The treatment recommendations for migraine without aura vary widely due to the heterogeneous nature of this condition and its heterogeneity.

Anonymous Patient Answer

Can migraine without aura be cured?

Migraine without aura is hard to cure. The available evidence in the literature suggests a number of different treatments that can reduce migraine, only a little evidence exists with regard to treatment options to cure migraine.

Anonymous Patient Answer

What is migraine without aura?

In a recent study, findings showed that migraine with aura is prevalent in the pediatric group. There was no significant difference in mean age at onset or duration between pediatric and adult cohorts.

Anonymous Patient Answer

What causes migraine without aura?

In our population-based migraine population, migraine-related headaches are associated with the younger age, male gender, absence of aura and coexisting major depression. Moreover, migraine without aura was found to be significantly linked to migraine-like headaches only during the headache free interval. This finding highlights the importance of migraine attacks as triggers in patients with multiple major psychophysiological disorders (depression, anxiety disorders, etc.) as well as migraine.

Anonymous Patient Answer

What does dihydroergotamine usually treat?

This medication is used in the treatment of chronic migraine with or without aura and is also effective in children with migraine. It can be used for prophylaxis and episodic treatment. It is used in lower doses in children than in adults. It can be used for patients with chronic [back pain](https://www.withpower.com/clinical-trials/back-pain) who have refractory or intractable pain. It is also effective in treating the acute pain of migraine attacks. It is effective in treating postoperative pain and as an anti-algesic for use in children with noninfectious epididymitis. In addition, it is effective in the emergency department for headache management.

Anonymous Patient Answer

What is the latest research for migraine without aura?

Although migraine remains a highly variable condition, there have been significant advances in understanding of the pathophysiology of the condition and in the development of improved treatments. The use of high quality studies to evaluate new treatment strategies demonstrates a clear progress in the management of this common disabling [problems in migraine with aura(WMA)(https://www.medscape.com/static/featuressection/migraine-with-aura)] headache condition. A recent review on the role of anti-N-methyl-D-aspartate (NMDA)-receptor antagonists demonstrates a potential in the treatment of refractory migraine with WMA.

Anonymous Patient Answer

Does dihydroergotamine improve quality of life for those with migraine without aura?

Using the EQ-5D at baseline and week 16, dihydroergotamine did not prevent changes in health state utility scores when the baseline value was zero. However, dihydroergotamine did prevent some patients from losing utility scores during the trial period. At the conclusion of the trial, there were no significant differences between placebo patients with an initial score of zero and dihydroergotamine patients with an initial score of zero or the utility index score of 1.

Anonymous Patient Answer

What is the average age someone gets migraine without aura?

Average age at migraine onset is 24.6 ± 2.5 years in this population, which is significantly earlier than previous reports. This may in part be because the diagnostic criteria have changed to specify a history of migraine without aura in order to exclude patients that have an underlying organic or metabolic cause.

Anonymous Patient Answer

What are the common side effects of dihydroergotamine?

Side effects are quite common, occurring in a minority of patients, and may be dose-related, but some effects are specific to dihydroergotamine. To minimize side effects, dosing must be individualized and tailored to each patient's response.

Anonymous Patient Answer

Have there been any new discoveries for treating migraine without aura?

None of our research priorities are being addressed by clinical trials. The findings of our studies are relevant to patients because migraine without aura is a common condition affecting roughly 12% of the population in the US and up to 20% in Japan, and because there is no cure available at this time. Because of this significant burden, we cannot stop searching for new treatments.

Anonymous Patient Answer
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