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Comparator: Rizatriptan

Phase 3

Migraine | Small molecule | Neurology |Organon & Co.|Last Updated: Feb 3, 2022

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment346
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00250458Study to Test a Marketed Product in the Treatment of Migraine-associated NauseaPHASE3 COMPLETED 346Mar 1, 2006Oct 1, 2006Feb 3, 2022 -
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Study Endpoints
Primary Endpoints
Participants With Elimination of Nausea at 2 Hours Postdose
At 2 hours after treatment

Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.

Secondary Endpoints
Participants With Pain Relief at 2 Hours Postdose
2 hours after treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALRizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate
2PLACEBO_COMPARATORmatching placebo
Interventions
NameTypeDescription
Comparator: RizatriptanDRUGOne dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
Comparator: PlaceboDRUGOne dose matching placebo to Rizatriptan to treat one migraine attack.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month Exclusion Criteria: * Heart disease, high blood pressure

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