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  • Symptomatic drugs for migraine management evaluated in placebo-controlled and open clinical trials

Symptomatic drugs for migraine management evaluated in placebo-controlled and open clinical trials

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References Drug Study Design Evidence level Dose Age(years) Number of patients Responders (%)
Active drug		 Responders (%)
Placebo		 p value
Hamalainen et al 1997 Ibuprofen RCT A 10 mg/kg 4–16 88 68 37 <0.05
Lewis et al 2002 Ibuprofen RCT   7.5 mg/kg 6–12 84 76 53 0.006
Evers et al 2006 Ibuprofen RCT   200–400 mg 6–18 32 69 28 <0.05
Hamalainen 1997 Acetaminophen RCT B 15 mg/kg 4–16 88 54 37 <0.05
Hamalainen et al 1997 Dihydroergotamine RCT C 20,40 microg/kg 5–15 12 58 16 NS
Ueberall 1999 Sumatriptan nasal RCT A 20 mg 6–10 14 86 43 0.03
Winner et al. 2001 Sumatriptan nasal RCT   5–10–20 mg 12–17 510 66* 53 <0.05
Ahonen et al. 2004 Sumatriptan nasal RCT   10–20 mg 8–17 83 64 39 0.003
Winner et al. 2006 Sumatriptan nasal RCT   20 mg 12–17 738 61 52 NS
Hamalainen et al. 1997 Sumatriptan oral RCT C 50–100 mg 8–16 23 30 22 NS
Mac Donald 1994 Sumatriptan sc. OT C 3–6 mg 6–16 17 64 – –
Linder 1996 Sumatriptan sc. OT   0.06 mg/kg 6–18 50 78 –   -
Winner et al. 2002 Rizatriptan RCT C 5 mg 12–17 196 66 56 NS
Visser et al. 2004 Rizatriptan RCT   5 mg 12–17 234 68 69 NS
Visser et al. 2004 Rizatriptan OT   5 mg 12–17 686 77 – –
Linder and Dowson 2000 Zolmitriptan oral OT C 2.5–5 mg 12–17 38 88–70 – –
Evers et al. 2006 Zolmitriptan oral RCT   2.5 mg 6–18 32 62 28 <0.05
Charles 2006 Almotriptan oral OT B 6.25–12.5 mg 11–17 15 86 – –
Linder et al. 2008 Almotriptan oral RCT   6.25–12.5–25 mg 12–17 866 67–73 55 <0.001

Evidence level

  • Level A: two or more clinically controlled, randomized studies carried out according to good clinical practice (GCP), versus placebo or versus active treatment of proven efficacy.
  • Level B: one clinically controlled, randomized study carried out according to GCP or more than one well-designed clinical case–control study or cohort study
  • Level C: favourable judgment of two-third of the Ad Hoc Committee members, historical controls, non-randomized studies, case reports
  • NS no statistically significant difference between active drug and placebo, RCT randomized controlled trial, OT open trial

*5 mg

Migraine prophylaxis

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