This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared with placebo as headache prophylaxis in Chinese participants with chronic migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Botulinum toxin Type A (BOTOX®) 155U to 195U IM injections in head/neck areas.
Placebo matching BOTOX® \[Sodium chloride 0.9 mg\] IM injections in head/neck areas.
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Week 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.
Time frame: Baseline, Week 24
Change from Baseline in the Frequency of Headache Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Weeks 4, 8, 12, 16 and 20. 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.
Time frame: Baseline, Weeks 4, 8, 12, 16 and 20
Change from Baseline in the Frequency of Migraine/Probable Migraine Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of migraine or probable migraine episodes during the 28-day period ending with Weeks 4, 8, 12, 16, 20 and 24. A Migraine or Probable Migraine day was defined as a calendar day \[00:00 to 23:59\] for which the patient reported ≥ 4 continuous hours of a migraine or probable migraine episode as per the patient diary.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24.
Change from Baseline in the Number of Moderate/Severe Headache Days during 28-Day Period
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28 day period ending with Weeks 4, 8, 12, 16, 20 and 24. A moderate/severe headache day is defined as a day (00:00 to 23:59) when a participant reported 4 or more continuous hours of headache and reported a maximum severity of moderate or severe per patient diary among all headache episodes that occurred on that day.
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Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day Period
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 4, 8, 12, 16, 20 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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24