Recent Updates
Recently added Catalysts

Telcagepant soft

Phase 3

Migraine | Small molecule | Neurology |Merck & Company, Inc.|Last Updated: Oct 17, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,068
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00443209Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)PHASE3 COMPLETED 1,068Feb 21, 2007Jan 22, 2009Oct 17, 2018 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)
Within 14 days of any dose of study drug (Up to 18.5 months)

Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.

Percentage of Participants With At Least One Clinical AE
Within 14 days of any dose of study drug (Up to 18.5 months)

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug.

Percentage of Participants With At Least One Laboratory AE
Within 14 days of any dose of study drug (Up to 18.5 months)

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.

Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Within 14 days of any dose of study drug (Up to 18.5 months)

Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (\>=180 mm Hg and 20 mm Hg increase OR \<=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (\>=105 mm Hg and 15 mm Hg increase OR \<=50 mm Hg and 15 mm Hg decrease), Pulse (\>=120 beats per minute \[bpm\] and 15 bpm increase OR \<=50 bpm and 15 bpm decrease), Body Temperature (\>38º C \[oral equivalent\]) and Respiratory Rate (\>25 or increase of 10 OR \<5 or decrease of 10 \[per minute\]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.

Secondary Endpoints
Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
2 hours post-dose (Up to 18 months)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Telcagepant 280 mg/300 mgEXPERIMENTALParticipants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
Rizatriptan 10 mgACTIVE_COMPARATORParticipants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
Interventions
NameTypeDescription
Telcagepant 300 mg soft gel capsulesDRUGOne capsule taken orally at onset of migraine
Telcagepant 280 mg tabletsDRUGOne tablet taken orally at onset of migraine
Rizatriptan 10 mg tabletsDRUGOne tablet taken orally at onset of migraine
Placebo to telcagepant capsulesDRUGOne capsule taken orally at onset of migraine
Placebo to telcagepant tabletsDRUGOne tablet taken orally at onset of migraine
Placebo to rizatriptan tabletsDRUGOne tablet taken orally at onset of migraine
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * At least 1 year history of migraine (with or without aura) * Females of child bearing potential must use acceptable contraception throughout trial * In general good health based on screening assessment Exclusion Criteria: * Pregnant/breast-feeding (or is a female expecting t...

Unlock Eligibility Criteria