Table 1 Schedules for evaluation of clinical trials in migraine

Acute

 Selection of patients

  Do the diagnostic criteria conform to those of the IHS? (+1/+0)

 Trial design

  Is the trial double blind? (+1/+0)

  Is the trial placebo-controlled? (+1/+0)

  Were the trial participants randomized at entry to the trial? (+1/+0)

 Evaluation of results

  IHS recommended

   Is the percentage of patients pain-free at 2 h used as a primary measure of efficacy? (+1/+0)

   Is sustained pain-free (percentage of patients pain-free within 2 h with no use of rescue medication or relapse within 48 h) used as a measure of efficacy? (+1/+0)

   Is “headache relief” (percentage of patients with a decrease in headache from severe or moderate to none or mild within 2 h before any rescue medication) used as a measure of efficacy? (+1/+0)

  Other

   Is the percentage of patients pain-free at 2 h used as a secondary measure of efficacy?

   Is sustained pain-free (percentage of patients pain-free within 2 h with no use of rescue medication or relapse within 24 h) used as a measure of efficacy?

Prophylaxis

 Selection of patients

  Do the diagnostic criteria conform to those of the IHS? (+1/+0)

  Do the patients’ attacks of migraine occur 2–6 times per month? (+1/+0)

 Trial design

  Is the trial double blind? (+1/+0)

  Is the trial placebo-controlled? (+1/+0)

  Were the trial participants randomized at entry to the trial? (+1/+0)

  Were the trial participants stratified for frequency of migraine attacks occurring during baseline? (+1/+0)

  Are treatment periods of at least 3 months used? (+1/+0)

 Evaluation of results

  IHS recommended

   Is frequency of migraine attacks per 4 weeks used as a primary measure of efficacy? (+1/+0)

   Is the number of days with migraine per 4 weeks used as a measure of efficacy? (+1/+0)

  Other

   Is the number of days with headache per 4 weeks used as a measure of efficacy?