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Table. 2.

Table. 2.

Characteristics of studies included in the meta-analysis of glutamate receptor antagonists for acute migraine treatment

ADX10059 (Raseglurant)LY293558 (Tezampanel)BGG492 (Selurampanel)
Intervention•Placebo (n=64) •ADX10059 375 mg p.o. (n=60)•Placebo (n=16) •Sumatriptan 6mg s.c (n=15) •LY293558 1.2mg/kg i.v (n=13)•Placebo (n=25) •Sumatriptan 100 mg p.o. (n=25) •BGG492 250 mg p.o. (n=25)

Designmc, r, db, pc, pg, phase 2mc, r, tb, ac & pc, pg, PoC, phase 2mc, r, db, ac & pc, pg, PoC, phase 2 (clinical trial leader unblinded)

Inclusion criteria•Patients with 18-65 years old · •IHS categories 1.1 and 1.2 · •2-8 migraine headaches/month •Migraine onset before 50 years of age •The stable dose of migraine prophylactic agents are allowed•Patients at least 18 years old •IHS categories 1.1 and 1.2 •1-15 migraine episodes/month •Past use of triptans •Administration of study drug within 8 hours of onset•Patients with 18-60 years old •IHS categories 1.1 and 1.2 •1-15 migraine episodes/month •Migraine onset before 50 years of age •Past use of triptans •Report to the center within 4 hours of onset

Exclusion criteria•>15 headache days/month •Taking medications that interact with ADX10059 •Pregnant or breast feeding women or women of childbearing potential, etc.•Pregnant or breastfeeding women or women of childbearing potential•>6 non-migraine headaches/month •Receiving migraine prophylaxis treatment •Taking medications that interact with BGG492 •Smokers, etc.

Primary endpoints• Pain free rate at 2 hrs post-dose ••The response rate at 2 hrs after infusion• The response rate at 2, 3 and 4 hrs post-dose.
Secondary endpoints•Time to pain-free and/or pain relief, • •24-h headache recurrence • •Presence of accompanying features of migraine •Use of rescue medication •Patients’ evaluation of study medication efficacy and adverse events•Pain-free rate at 2 hrs •>2-point improvement in pain score at 2 hrs •Sustained response •Sustained pain free •Relief of associated symptoms •Use of a rescue medication•Pain-free rate at 2, 3, and 4 hours •>2-point improvement in pain score •Sustained response rate •Sustained pain-free rate •Relief of associated symptoms •Recurrence rate

Abbreviation: mc:multi center; r:randomized; db:double-blinded; tb:triple-blinded; ac:active-controlled; pc:placebo-controlled; pg:parallel- group; PoC:Proof of Concept study; IHS:International Headache Society

Korean J Clin Pharm 2019;29:247-53 https://doi.org/10.24304/kjcp.2019.29.4.247
© 2019 Korean J Clin Pharm