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MK0657

Phase 1

Parkinson's Disease | Small molecule | Neurology |Merck & Company, Inc.|Last Updated: Jan 29, 2015

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00505843A Study of MK0657 in Parkinson's Disease Patients (0657-006)PHASE1 COMPLETED 18May 1, 2007Feb 1, 2008Jan 29, 2015 -
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Study Endpoints
Primary Endpoints
Efficacy will be assessed for up to 8 hours by the Unified Parkinson's Disease Rating Scale-Motor Examination and a modified AIMS dyskinesia scale
45 Days
Secondary Endpoints
Safety and Tolerability
45 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1OTHER7mg MK0657 capsules + \>/=1.0 mg/kg/hr dose of levodopa.
2OTHER7mg MK0657 Pbo capsules + \>/=1.0 mg/kg/hr dose of levodopa.
Interventions
NameTypeDescription
MK0657DRUG7mg MK0657 capsules
Comparator: Placebo (unspecified)DRUG7mg MK0657 Pbo capsules
Comparator: levodopaDRUGlevodopa \>/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period
Comparator: carbidopaDRUGcarbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Parkinson's Disease patients between the ages of 40 and 80 inclusive * Patient is in general good health based on screening assessments * Patient is willing to discontinue anti-parkinson's medications at least 8 hours prior to dosing * Patient is levodopa responsive with levod...

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