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AGN 203818

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment330

FDA Designations

No designations recorded

Clinical trial landscape

AGN 203818 · 1 trial · 1 indication

Phase 2 1
NCT00381719Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral NeuropathyDiabetic Neuropathy, Painful
COMPLETED330 Analytics
PHASE2COMPLETED
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
Diabetic Neuropathy, PainfulUnlock trial analytics

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 to 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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Frequently asked questions about AGN 203818

What is AGN 203818 used for?

AGN 203818 is an investigational small molecule being developed for the treatment of painful diabetic neuropathy, a type of nerve damage caused by diabetes that leads to pain, typically in the legs and feet. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes AGN 203818?

AGN 203818 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is an investigational small molecule in Phase 2 clinical development for the treatment of painful diabetic neuropathy.

What phase is AGN 203818 in?

AGN 203818 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities such as the U.S. Food and Drug Administration. The drug is being studied for the treatment of painful diabetic neuropathy.

What clinical trials is AGN 203818 in?

AGN 203818 has one completed clinical trial, identified as NCT00381719, titled "Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy." This Phase 2 study enrolled 330 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is AGN 203818 FDA approved?

AGN 203818 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of painful diabetic neuropathy. The drug has completed one clinical trial, but it has not yet received regulatory approval for any use.