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We studied the safety and efficacy of 0 U, 50 U, 100 U, 150 U (five sites), 86 Usub and 100 Usub (three sites) botulinum toxin type A (BoNTA; BOTOX ; Allergan, Inc., Irvine, CA, USA)- for the prophylaxis of chronic tension- type headache (CTTH). Three hundred patients (62.3% female; mean age 42.6 years)- enrolled. For the primary endpoint, the mean change from baseline in the number of TTH- free days per month, there was no statistically significant difference between placebo and four BoNTA groups, but a significant difference favouring placebo vs. BoNTA 150 was observed (4.5 vs. 2.8 tension headachefree days/month; P = 0.007). All treatment groups improved at day 60. Although efficacy was not demonstrated for the primary endpoint, at day 90, more patients in three BoNTA groups had ≥ 50% decrease in tension headache days than did placebo (P ≤ 0.024). Most treatment- related adverse events were mild or moderate, and transient. BoNZA was safe and well- tolerated in the study.
We studied the safety and efficacy of 0 U, 50 U, 100 U, 150 U (five sites), 86 Usub and 100 Usub (three sites) botulinum toxin type A (BoNTA; BOTOX; Allergan, Inc., Irvine, CA For the primary endpoint, the mean change from baseline in the number of TTH-free (Thompson®), for the primary endpoint, the mean change from baseline in the number of TTH-free days per month, there was no statistically significant difference between placebo and four BoNTA groups, but a significant difference favored placebo vs. BoNTA 150 was observed (4.5 vs. 2.8 tension headachefree days / month; P = 0.007). All treatment groups improved at day 60. Although efficacy was not demonstrated for the primary endpoint, at day 90, more patients in three BoNTA groups had ≥ 50% decrease in tension headache days than did placebo (P ≤ 0.024). Most treatment- related adverse events were mild or moderate, and transient. BoNZA was safe and well-tolerated in the study.