Migraine Disorders
Conditions
Brief summary
This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.
Interventions
BIOLOGICALonabotulinumtoxinA
Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
Sponsors
Allergan
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
* Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
Exclusion criteria
* Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis * Headache attributed to another disorder * Infection or skin disorder at injection sites * Previous treatment with botulinum toxin of any serotype for any reason * Anticipated need for botulinum toxin of any type for any reason during the course of the study * Previous participation in any botulinum toxin clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Frequency of Headache Days | Baseline, Week 108 | Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Frequency of Headache Days | Baseline, Week 60 | Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement. |
| Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score | Baseline, Week 60, Week 108 | The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening. |
Countries
Australia, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BOTOX® Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas. | 716 |
| Total | 716 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 25 |
| Overall Study | Lack of Efficacy | 35 |
| Overall Study | Lost to Follow-up | 82 |
| Overall Study | Missing | 1 |
| Overall Study | Other Miscellaneous Reasons | 43 |
| Overall Study | Pregnancy | 5 |
| Overall Study | Protocol Violation | 60 |
| Overall Study | Subject Withdrew Consent | 92 |
Baseline characteristics
| Characteristic | BOTOX® |
|---|---|
| Age, Customized < 40 years | 270 participants |
| Age, Customized ≥ 40 years | 446 participants |
| Gender Female | 607 Participants |
| Gender Male | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 75 / — |
| serious Total, serious adverse events | 75 / 716 |
Outcome results
Primary
Change From Baseline in the Frequency of Headache Days
Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 108
Population: Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BOTOX® | Change From Baseline in the Frequency of Headache Days | Baseline | 22.0 headache days | Standard Deviation 4.82 |
| BOTOX® | Change From Baseline in the Frequency of Headache Days | Change from Baseline at Week 108 | -10.7 headache days | Standard Deviation 6.44 |
Secondary
Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.
Time frame: Baseline, Week 60, Week 108
Population: Participants from the Analysis Population, all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BOTOX® | Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score | Baseline | 64.7 score on a scale | Standard Deviation 4.82 |
| BOTOX® | Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score | Change from Baseline at Week 60 | -6.8 score on a scale | Standard Deviation 6.55 |
| BOTOX® | Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score | Change from Baseline at Week 108 | -7.1 score on a scale | Standard Deviation 7.24 |
Secondary
Change From Baseline in the Frequency of Headache Days
Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 60
Population: Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BOTOX® | Change From Baseline in the Frequency of Headache Days | Baseline | 22.0 headache days | Standard Deviation 4.82 |
| BOTOX® | Change From Baseline in the Frequency of Headache Days | Change from Baseline at Week 60 | -9.2 headache days | Standard Deviation 6.22 |