Efficacy of ADAM Zolmitriptan for the Acute Treatment of Difficult-to-Treat Migraine Headaches

Stewart J. Tepper, MD; David W. Dodick, MD; Peter C. Schmidt, MD, MSc; Donald J. Kellerman, PharmD

Disclosures

Headache. 2019;59(4):509-517. 

In This Article

Results

A total of 365 patients were randomized; 321 were treated and had at least 1 post-treatment symptom assessment (mITT population). Patient demographics and baseline characteristics as well as primary study results were reported previously.[23] Of the 321 treated, 77 received placebo, and 82 were treated with ADAM zolmitriptan 3.8 mg. The incidences of migraine headaches in each of the analyzed subgroups (severe pain at the time of treatment, nausea at the time of treatment, treatment ≥2 hours after onset, and headaches present upon awakening in the morning) are presented in Table 1.

No significant effects (all P > .200) were observed in logistical regression models of treatment by subgroup interaction, suggesting that none of the subgroups modify the effect of ADAM zolmitriptan 3.8 mg compared to placebo (overall interaction P = .353). The following results further support this finding.

Table 2 shows the percentages of patients with MBS freedom or pain freedom stratified by pain intensity (moderate or severe). The numbers of patients with MBS freedom were higher in the ADAM zolmitriptan 3.8 mg group compared with the placebo group for both moderate and severe pain. For pain freedom, differences between the groups were significant for those with moderate pain, but not those with severe pain.

Among those with severe pain, pain relief (defined as improvement from moderate to severe headache pain to mild or no pain) was achieved in 69% (27/39) of those treated with ADAM zolmitriptan 3.8 mg and 46% (15/33) of those who received placebo (P = .026). Corresponding values for those with moderate pain were 91% (39/43) and 66% (29/44) (P = .009). The frequency of pain recurrence following relief is shown in Table 3. Overall, recurrence was lower in the active treatment group at both 24 and 48 hours compared with placebo.

Nausea at the time of treatment was reported in 69% (110/159) of patients (n = 51 in the placebo group and n = 59 in the active treatment group). Among these, more patients in the zolmitriptan 3.8 mg group were pain-free or MBS-free 2 hours post-dose compared with those in the placebo group (Table 4).

The mean time to migraine treatment after patient-estimated headache onset among all groups was 4.96 hours and the median was 1.79 hours. In those who waited for 2 or more hours to treat their migraine (n = 40 in the placebo group and n = 36 in the active treatment group), 2-hour pain freedom and 2-hour MBS freedom were both more frequent in the active treatment group (Table 5).

Fifty-one percent (80/159) of patients overall reported waking up with pain already present at moderate to severe intensity (n = 44 in the placebo group and n = 36 in the zolmitriptan group). In those who awoke with migraine, the frequencies of 2-hour pain freedom and 2-hour MBS freedom were both higher in the zolmitriptan 3.8 mg group relative to placebo (Table 6). The frequency of pain recurrence at 24 hours and at 48 hours was also lower in the active treatment group (Table 3).

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....