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AGN 203818

Phase 2

Diabetic Neuropathy, Painful | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jan 7, 2008

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 Enrollment330
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00381719Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral NeuropathyPHASE2 COMPLETED 330Oct 1, 2006Nov 1, 2007Jan 7, 20081 United States
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Study Endpoints
Primary Endpoints
Reduction in Daily Pain Score
1 Month
Secondary Endpoints
Changes in sleep interference score
Week 4
Beck depression inventory
Week 4
Quality of Life questionnaires
Week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL3 mg
2EXPERIMENTAL20 mg
3EXPERIMENTAL60 mg
4PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
AGN 203818DRUG3 mg Capsule twice daily for 4 weeks
placebo capsuleDRUGCapsule twice daily for 4 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of diabetic peripheral neuropathy * Moderate to severe neuropathic pain Exclusion Criteria: * Any other uncontrolled disease * Pregnant or nursing females

Countries:United States
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