Migraine Disorders
Conditions
Brief summary
This study is an open-label extension study to evaluate the safety, tolerability and efficacy of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.
Interventions
BIOLOGICALbotulinum toxin Type A
Botulinum toxin Type A (BOTOX®) IM 155U to 195U injections in head/neck areas.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
-Has successfully completed the double-blind study (1313-301-008).
Exclusion criteria
* Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings * Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma) * Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with AEs Leading to Discontinuation | 24 Weeks | — |
| Change from Baseline in 12-Lead Electrocardiograms (ECGs) Parameters | Baseline, Week 24 | A standard 12-lead ECG will be performed at Baseline and Week 24. |
| Change from Baseline in Clinical Laboratory Parameters | Baseline, Week 24 | Blood samples will be collected at Baseline and Week 24 for standard clinical laboratory testing including hematology, chemistry, urinalysis an immunogenicity parameters. |
| Number of Participants with Adverse Events (AEs) | 24 Weeks | An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. |
| Change from Baseline in Vital Signs | Baseline, Week 24 | Vital signs include blood pressure and pulse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day period | Baseline, Weeks 12 and 24 | Mean change from Baseline (28-days prior to first treatment) in the total cumulative hours of headache days during the 28-day period ending with Weeks 12 and 24. A headache day is defined as a day (00:00 to 23:59) with 4 or more continuous hours of headache per patient diary. |
| Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Weeks 12 and 24 | Baseline, Weeks 12 and 24 | Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Weeks 12 and 24. A headache day was defined as a calendar day \[00:00 to 23:59\] for which the participant reported ≥ 4 continuous hours of headache per patient diary. |
Outcome results
None listed