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Almotriptan

Phase 3

Migraine | Small molecule | Neurology |Johnson & Johnson|Last Updated: Feb 21, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment1,313
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00257010A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine HeadachesPHASE3 COMPLETED 447 — — Dec 1, 2005Dec 1, 2007Feb 21, 201449 United States
NCT00210483A Study of 3 Dosage Strengths of Almotriptan Malate (AXERT®) in the Treatment of Acute Migraine in AdolescentsPHASE3 COMPLETED 866 — — Jul 1, 2003Jul 1, 2005May 17, 2011 - —
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Study Endpoints
Primary Endpoints
Number of Pain Free Headaches at 2 and 24 Hours Post-Dose
2 hours and 24 hours post-dose

Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.

Efficacy determined by patient 2 hours after dosing by rating of headache intensity as a decrease from moderate or severe to mild or no pain
Secondary Endpoints
Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose
2 hours and 24 hours post-dose
Number of Headaches With Photophobia
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Number of Headaches With Phonophobia
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Almotriptan MalateEXPERIMENTALPatients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
Interventions
NameTypeDescription
Almotriptan MalateDRUGPatients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
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Eligibility Criteria
Age Range12 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Have a history of migraine for at least one year * Have an average of 1 - 14 migraines per month for the 6 months prior to study entry * Able to swallow oral medication * Able to complete a headache diary * Only taking one migraine preventive medication and on the same dose of...

Countries:United States
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Competitive Landscape -Migraine 32 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV15PHASE3Atogepant, Topiramate, Ubrogepant, MEDI0618
Pfizer Inc.PFE9PHASE3Rimegepant, Rimegepant/BHV3000, Zavegepant, Various, Rimegepant for acute migraine treatment
Eli Lilly and CompanyLLY2PHASE3Galcanezumab
Amgen Inc.AMGN2PHASE3Erenumab Dose 1, erenumab-aooe
Ki Health Partners. LLCRVNC1 — Daxibotulinumtonix A
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