Migraine Headache
Conditions
Keywords
migraine headache, Botulinum Toxin Type A, BOTOX, BTX-A
Brief summary
The purposes of this study are to assess whether subjects treated with BOTOX will: 1. have a decrease in the frequency and intensity of migraine headaches 2. experience improvements in quality of life 3. experience a reduction in the frequency of health care services obtained.
Interventions
DRUGBotulinum Toxin Type A
100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)
Sponsors
Allergan
HealthPartners Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects \> 18 years of age * Subject has an established history of migraine headache, with or without aura, per IHS criteria (1.2.1 or 1.1), for at least 6 months prior to screening. * Subject receives primary health care from Park Nicollet Health Services.
Exclusion criteria
* Subject has received previous injections of botulinum toxin of any serotype for any reason, within the 6 months prior to study participation. Additional eligibility will be discussed at point of contact
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. | 190 days |
Secondary
| Measure | Time frame |
|---|---|
| To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache. | 190 days |
| To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache. | 190 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Time frame: 190 days
Population: Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data
Secondary
To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.
Time frame: 190 days
Population: Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data
Secondary
To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.
Time frame: 190 days
Population: Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data