Ubrogepant (MK-1602)

A Phase 3 trial to evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral ubrogepant in the acute treatment of migraine with or without aura in children and adolescents (ages 6-17) (NCT05125302)

Study title/design: A Phase 3 trial to evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral ubrogepant in the acute treatment of migraine with or without aura in children and adolescents (ages 6-17) (NCT05125302) Trial NCT05125302 – recruiting Aim To assess adverse events and disease activity of oral ubrogepant tablets for the acute treatment of …

A randomized, parallel-group, single-attack, open-label study to evaluate the efficacy of almotriptan and ubrogepant for the acute treatment of migraine (ATOM) (NCT05214001)

Study title/design: A randomized, parallel-group, single-attack, open-label study to evaluate the efficacy of almotriptan and ubrogepant for the acute treatment of migraine (ATOM, NCT05214001) Trial NCT05214001 – recruiting Aim To evaluate the efficacy of almotriptan and ubrogepant for the acute treatment of migraine. Study design A non-inferiority study of almotriptan 12.5 mg and ubrogepant 50 …

A prospective observational diary study to evaluate the real-world effectiveness of acute treatment of migraine with ubrogepant when used in combination with atogepant for prevention (COURAGE II) (NCT057653986)

Study title/design: A prospective observational diary study to evaluate the real-world effectiveness of acute treatment of migraine with ubrogepant when used in combination with atogepant for prevention (COURAGE II, NCT057653986) Trial NCT05653986 Aim To assess change in disease activity when ubrogepant tablets are combined with atogepant tablets to treat migraine in adult participants. Study design …

Ubrogepant efficacy and safety in the treatment of acute migraine in patients currently treated with CGRP monoclonal antibodies (UNION) (NCT05503082)

Study title/design: Ubrogepant efficacy and safety in the treatment of acute migraine in patients currently treated with CGRP monoclonal antibodies (UNION, NCT05503082) Trial NCT05503082 Aim To evaluate the safety and efficacy of ubrogepant in patients currently treated with one of the injectable monoclonal antibodies targeting CGRP or the CGRP receptor (erenumab, galcanezumab of fremanezumab). Study …

Oral ubrogepant in the acute treatment of migraine when administered during the prodrome (PRODROME) (NCT04492020)

Study title/design: Oral ubrogepant in the acute treatment of migraine when administered during the prodrome (PRODROME) (NCT04492020) Trial NCT04492020 Aim To evaluate the efficacy, safety and tolerability of oral ubrogepant 100 mg in the acute treatment of migraine when administered during the prodrome Study design Adults aged 18-75 years randomised to ubrogepant 100 mg or …

A Phase 1b, two-part, open-label, fixed-sequence, safety, tolerability and drug-drug interaction study between single dose erenumab or galcanezumab and multiple dose ubrogepant in participants with migraine (NCT0417974)

Study title/design: A Phase 1b, two-part, open-label, fixed-sequence, safety, tolerability and drug-drug interaction study between single dose erenumab or galcanezumab and multiple dose ubrogepant in participants with migraine (NCT0417974) Trial NCT0417974 Aim To evaluate the potential of a pharmacokinetic (PK) interaction and provide safety and tolerability information when ubrogepant and erenumab or ubrogepant and galcanezumab …

A Phase 1 multicentre, double-blind, parallel-group trial of intermittent, high-frequency ubrogepant dosing in healthy adults

Ubrogepant (MK-1602) Study title/design: A Phase 1 multicentre, double-blind, parallel-group trial of intermittent, high-frequency ubrogepant dosing in healthy adults Trial n/a Aim To evaluate the safety and tolerability of ubrogepant, focusing on hepatic safety, when administered intermittently with high-frequency dosing to healthy participants. Study design Healthy adults (age 18-50 years) were randomised 1:1 to placebo or ubrogepant. …

A Phase 3 multicentre, randomised, open-label extension study to evaluate the long-term safety and tolerability of oral ubrogepant in the acute treatment of migraine with or without aura

Ubrogepant (MK-1602) Study title/design: A Phase 3 multicenter, randomized, open-label extension study to evaluate the long-term safety and tolerability of oral ubrogepant in the acute treatment of migraine with or without aura Trial NCT02873221 Aim To evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year. …

A Phase 3, multicentre, randomised, double-blind, placebo controlled single attack study to evaluate the efficacy, safety, and tolerability of oral ubrogepant in the acute treatment of migraine (ACHIEVE I)

Ubrogepant (MK-1602) Study title/design: A Phase 3, multicentre, randomised, double-blind, placebo controlled single attack study to evaluate the efficacy, safety, and tolerability of oral ubrogepant in the acute treatment of migraine (ACHIEVE I) Trial NCT02828020 Aim To evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for …

A Phase 2 dose-finding study of MK-1602 in the treatment of acute migraine (MK-1602-006)

Ubrogepant (MK-1602) Study title/design: A Phase 2 dose-finding study of MK-1602 in the treatment of acute migraine (MK-1602-006) Trial NCT01613248: https://clinicaltrials.gov/ct2/show/NCT01613248 Aim To assess the effectiveness, safety and tolerability of a range of doses of MK-1602 versus placebo in the treatment of acute migraine. Study design Ubrogepant 1, 10, 25, 50 and 100 mg single …

A Phase 3, multicentre, randomised, double-blind, placebo controlled single attack study to evaluate the efficacy, safety, and tolerability of oral ubrogepant in the acute treatment of migraine (ACHIEVE II)

Ubrogepant (MK-1602) Study title/design: A Phase 3, multicentre, randomised, double-blind, placebo controlled single attack study to evaluate the efficacy, safety, and tolerability of oral ubrogepant in the acute treatment of migraine (ACHIEVE II) Trial NCT02867709 Aim To evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for …