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ABT-894

Phase 2

Diabetic Neuropathic Pain | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jan 21, 2013

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00548925A Safety and Efficacy Study in Subjects With Diabetic Neuropathic PainPHASE2 COMPLETED 124 — — Nov 1, 2007Dec 1, 2008Jan 21, 201329 United States, Czechia +5
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Study Endpoints
Primary Endpoints
Weekly mean of 24-hour average pain score
Change from Baseline to final
Secondary Endpoints
Pain improvement from Baseline to the final evaluation
8-week
Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain
8-week
Global assessments of study drug and pain status
8-week
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ABT-894DRUG6 mg BID tablets, 8 weeks of treatment
placeboDRUGBID tablets, 8 weeks of treatment
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Males and females, age 18 to 75 * If female, must be of non-childbearing potential or practicing birth control * Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy * Has had pain from distal symmetric diabetic polyneuropathy...

Countries:United StatesCzechiaFranceGermanyItalySpainUnited Kingdom
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