BOTOX for Episodic Migraine

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
AppleTree Clinics /ID# 245687, Łódź, Poland
Episodic Migraine+1 More
BOTOX - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a treatment for migraine can prevent migraine attacks in adults with episodic migraine.

See full description

Eligible Conditions

  • Episodic Migraine

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Episodic Migraine

Study Objectives

This trial is evaluating whether BOTOX will improve 1 primary outcome and 6 secondary outcomes in patients with Episodic Migraine. Measurement will happen over the course of 6 Months.

6 Months
Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score
Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score
Change From Baseline in the Frequency of Monthly Acute Headache Medication Days
Change From Baseline in the Frequency of Monthly Headache Days
Change From Baseline in the Frequency of Monthly Migraine Days
Change From Baseline in the Frequency of Monthly Neck Pain Days Associated With Headache Among Participants Who Report at least 1 day of Neck Pain Associated With Headache During Baseline
Responder Status of 50% Reduction From Baseline in the Frequency of Monthly Migraine Days

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Episodic Migraine

Trial Design

3 Treatment Groups

BOTOX Dose A
1 of 3
BOTOX Dose B
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 777 total participants across 3 different treatment groups

This trial involves 3 different treatments. BOTOX 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.

BOTOX Dose A
Drug
Participants will receive BOTOX Dose A on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
BOTOX Dose B
Drug
Participants will receive BOTOX Dose B on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
PlaceboParticipants will receive placebo on Week 0 and Week 12. Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Neurology and Neurodiagnostics of Alabama /ID# 231918 - Hoover, AL

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
Some people experienced between six and 14 days with migraine or probable migraine during the four-week screening/baseline phase. show original
The person had less than 15 headache days per month in each of the 3 months prior to the first visit and during the 4-week baseline phase. show original
The person has had a migraine headache disorder meeting the International Classification of Headache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migraine without aura for at least 12 months. show original
Some people experience migraine headaches before the age of 50. show original
The person has had six to fourteen migraine days in each of the three months prior to the first visit. show original

Patient Q&A Section

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

"According to the results of this study, 1.6 million people seek care at the emergency department in the United States for sickness headache, as compared to 8.2 million patients in 2004. This may reflect improved recognition and diagnosis of headache illnesses, or increased demand for emergency service on the part of patients. The increase of sick headache cases to 8.2 million may indicate an increase in the number of headache-specific emergency department visits. Further research is urgently required to clarify the underlying reasons for this increase and to understand the nature and appropriateness of current diagnostic practice." - Anonymous Online Contributor

Unverified Answer

What are the signs of sick headache?

"The presentation of sick headache remains a puzzle, as does the etiology of recurrent episodes. It is likely that the same factors contributing to disease severity, such as pain, fatigue and insomnia, are involved in the genesis of a recurrence. Nevertheless, an underlying genetic vulnerability needs to be considered." - Anonymous Online Contributor

Unverified Answer

Can sick headache be cured?

"Despite advances in treatment and knowledge of mechanisms of headache, sick headache syndrome cannot be cured. A lack of cure in this condition suggests that there may be a biological abnormality in brain circuits, which make headache." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sick headache?

"Antiseizure drugs, anticytotoxic medication, acetylsalicylic acid, diuretics, and lifestyle changes (fatigue reduction, exercise, sleep hygiene, stress management, and psychological support) are common treatments for sick headache. More than 80% of migraine sufferers suffer pain in conjunction with one or more co-morbid conditions. There are many more possible treatments for headache than those cited, but some treatments are generally only available by prescription or by online prescription. The more often used treatments, however, may be readily available or even recommended. For example, treatment with analgesics are recommended for the headache pain, as well as for pain resulting from injuries and illnesses." - Anonymous Online Contributor

Unverified Answer

What causes sick headache?

"A common trigger of sick headache is stress from an event such as trauma, illness or a sudden change in mood. Other causes of sick headache include physical inactivity or drug use, although these are less common in children. Inadequate or excessive fluid intake is believed to be another cause of sick headache, but this finding is difficult to validate." - Anonymous Online Contributor

Unverified Answer

What is sick headache?

"Sick headache is a disorder of unknown cause that is characterised by severe headache with high frequency of attacks without any apparent cause. It can be confused with migraine, tension headache and other headache disorders." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets sick headache?

"We found that 23.6 percent of all people with sick headache were aged under the age of 20. Half of these people were under the age of 10 years, while only 3 percent of people with sick headache were over the age of 65. There was also a gender difference in this age group. Girls were more likely than boys to get sick headache between the ages 10 and 19 (25.3 percent vs. 20.2 percent; P<0.001). Moreover, the more commonly reported reasons for getting sick headache were that girls were more likely to have headache as a result of crying (23.3 percent vs. 18.7 percent; P<0.001)." - Anonymous Online Contributor

Unverified Answer

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

"Results from a recent paper suggest that botox does not improve QOL regardless of its effects on headache frequency, intensity, duration, or quality of life. Botox should be targeted to the treatment of symptoms or the impact of headache-related disability, rather than to reduce headache frequency or intensity." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in botox for therapeutic use?

"The use of botulinum A toxin (botox) for therapeutic purpose was first described by Paul G. Wittmack (U.S. Army) in 1965. Later, with the development of other new toxin types, the indications to use botox (botulinum type A) were expanded to headaches, blepharospasm, hyperhidrosis, chronic migraine, overactive bladder and cervical dystonia. Botox has the advantages of a wide availability and low cost, and less invasive to the patient’s body, but has several side effects, such as pain, swelling, bruising, numbness and weakness. Clinical studies aiming for more efficient clinical use of Botox are still required." - Anonymous Online Contributor

Unverified Answer

Is botox typically used in combination with any other treatments?

"[Overall, most patients use Botox as a co-treatment with other drugs but most do not report the type of medications that they use with Botox in a separate area]. The medications most frequently used with Botox are: analgesics [such as NSAIDs and oxycodone (sic)], muscle relaxants, [anticonvulsants such as lamotrigine (sic), baclofen (sic) and diazepam (<5% use), antidepressants, neuroleptics, anti-sedating agents such as benzodiazepines and antihistamines, and pro-phylactic treatments. The use of Botox is often prescribed as well." - Anonymous Online Contributor

Unverified Answer

What does botox usually treat?

"The most common uses are to treat pain (nervous, muscular), to soften a line, or to prevent bulging. Because botox reduces muscle tone and may result in cosmetic results, such injections are most commonly performed under local anesthesia. Botulism is an uncommon condition that occurs in children after consumption of certain bacterial toxin. After botulinum toxin-A was first produced in 1911, botulism was thought to be rare. Botulinum toxin decreases the contractility of skeletal muscle and may be used to treat skeletal muscle dystonia, spasticity, and other conditions of skeletal muscle dysfunction that otherwise are difficult to treat." - Anonymous Online Contributor

Unverified Answer

Is botox safe for people?

"There has been a high suspicion in the media since its introduction that botulinum toxin causes serious complications. This is not the case. In the event of an injection that is technically or intentionally incorrect, the resultant complications are extremely rare and usually very mild. Most often, they are of no relevance. These complications are in any case extremely unlikely to be life-threatening." - Anonymous Online Contributor

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