Recent Updates
Recently added Catalysts

ABT-894

Phase 2

Diabetic Neuralgia | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jan 23, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment280

FDA Designations

No designations recorded

Clinical trial landscape

ABT-894 · 2 trials · 6 indications

Phase 2 2
NCT00548925A Safety and Efficacy Study in Subjects With Diabetic Neuropathic PainDiabetic Neuropathic Pain
COMPLETED124 Analytics
NCT00507936Safety and Efficacy Study in Subjects With Diabetic Neuropathic PainDiabetic Neuralgia
COMPLETED280 Analytics
PHASE2COMPLETED
A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
Diabetic Neuropathic PainUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
Diabetic NeuralgiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Weekly mean of 24-hour average pain score
Change from Baseline to final
Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP
Change from baseline to final 24-hour average pain score

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
AEXPERIMENTALABT-894 1 mg BID
BEXPERIMENTALABT-894 2 mg BID
CEXPERIMENTALABT-894 4 mg BID
DPLACEBO_COMPARATOR -
EACTIVE_COMPARATORDuloxetine 60 mg QD

Interventions

NameTypeDescription
ABT-894DRUG6 mg BID tablets, 8 weeks of treatment
placeboDRUGBID tablets, 8 weeks of treatment
DuloxetineDRUGDuloxetine 60 mg QD throughout treatment period
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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 KingdomCanadaMexicoPuerto Rico
Unlock Eligibility Criteria

Frequently asked questions about ABT-894

What is ABT-894 used for?

ABT-894 is an investigational small molecule being developed for diabetic neuropathic pain and diabetic neuralgia. It is a neurology therapeutic that has been studied in Phase 2 clinical trials for these painful diabetic neuropathy conditions.

Who makes ABT-894?

ABT-894 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule in Phase 2 clinical development for diabetic neuropathic pain.

What phase is ABT-894 in?

ABT-894 is in Phase 2 clinical development. It is an investigational drug, not yet approved by the FDA, and has completed Phase 2 trials for diabetic neuropathic pain and diabetic neuralgia.

What clinical trials is ABT-894 in?

ABT-894 has completed two Phase 2 clinical trials. NCT00507936 enrolled 280 participants with diabetic neuropathic pain across the US, Canada, France, Germany, Italy, Mexico, and Puerto Rico. NCT00548925 enrolled 124 participants in the US, Czechia, France, Germany, Italy, Spain, and the UK.

Is ABT-894 the same as any other drug?

ABT-894 is the primary name for this investigational compound. No alternative names have been disclosed for this drug in the clinical trial data.