Refractory Migraine
Conditions
Keywords
Migraine, refractory migraine, Pain, Botulinum Toxin , Botox
Brief summary
The hypothesis of this study is that injection of botulinum toxin A into the muscles around the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and frequency of migraine headaches by 50%.
Detailed description
Contact PI for study details
Interventions
DRUGBotox
subjects randomized to receive Botox with have a series of injections of onobotulinumtoxinA totalling 200 to 300 units. Botox is prepared b adding 1cc of preservative free saline in 100 unit vial. Final dose is determined by bod and neck size.
OTHERPlacebo
subjects randomized to receive Placebo will have a series of injections of saline solution totalling 2cc's to 3cc's injected into the scalp in a halo pattern; and into affected neck muscles.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 and older * Migraine for more than three months, that fail to respond to two or more major anti-migraine drug, meeting criteria of chronic migraine
Exclusion criteria
* Age below 18 * Pregnant or may become pregnant * Disease of neuromuscular junction or drugs that affect N-M junction * Allergy to Botox * Previous use of Botox for migraine by similar methodology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Days of Decrease in Pain Level Using VAS | 4 weeks | Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Satisfied With Treatment | 4 weeks | Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 12 |
| Botox | 13 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Placebo | Botox | Total |
|---|---|---|---|
| Age, Continuous | 59 years | 61 years | 60 years |
| Pain | 8.1 units on a scale | 8.3 units on a scale | 8.24 units on a scale |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 1 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
Primary
Mean Number of Days of Decrease in Pain Level Using VAS
Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Number of Days of Decrease in Pain Level Using VAS | 1.20 days | Standard Deviation 5.63 |
| Botullinum Toxin | Mean Number of Days of Decrease in Pain Level Using VAS | 8.67 days | Standard Deviation 8.18 |
p-value: 0.0347t-test, 2 sided
Secondary
Number of Participants Satisfied With Treatment
Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Satisfied With Treatment | 9 participants |
| Botullinum Toxin | Number of Participants Satisfied With Treatment | 3 participants |
p-value: 0.03Fisher Exact