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AGN-214868

Phase 2

Neuralgia, Postherpetic | Small molecule | Pain |AbbVie Inc.|Last Updated: Mar 19, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment294

FDA Designations

No designations recorded

Clinical trial landscape

AGN-214868 · 2 trials · 2 indications

Phase 2 2
NCT01157377Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary IncontinenceUrinary Bladder, Overactive
COMPLETED160 Analytics
NCT01129531A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic NeuralgiaNeuralgia, Postherpetic
COMPLETED294 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
Urinary Bladder, OveractiveUnlock trial analytics
PHASE2COMPLETED
A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
Neuralgia, PostherpeticUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
Baseline, Week 12

The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).

Change From Baseline in the Average Pain Intensity Score at Week 12
Baseline, Week 12

Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.

Secondary Endpoints

Change From Baseline in Area of Spontaneous Pain
Baseline, Week 12
Change From Baseline in Area of Allodynia
Baseline, Week 12
Change From Baseline in Evoked Pain Score in the Area of Allodynia
Baseline, Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AGN-214868 total dose 500 ngEXPERIMENTALAGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
AGN-214868 total dose 1000 ngEXPERIMENTALAGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
AGN-214868 total dose 2000 ngEXPERIMENTALAGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
AGN-214868 total dose 6000 ngEXPERIMENTALAGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
AGN-214868 total dose 18000 ngEXPERIMENTALAGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
AGN-214868 total dose 60000 ngEXPERIMENTALAGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
Placebo to AGN-214868PLACEBO_COMPARATORPlacebo to AGN-214868 injected into the bladder on Day 1.
AGN-214868 3.25 μgEXPERIMENTALAGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
AGN-214868 16.25 μgEXPERIMENTALAGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
PlaceboPLACEBO_COMPARATORPlacebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.

Interventions

NameTypeDescription
AGN-214868DRUGAGN-214868 injected into the bladder.
AGN-214868 placeboDRUGAGN-214868 placebo injected into the bladder.
Placebo to AGN-214868DRUGPlacebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * If female, must be of nonreproductive potential * If male, must agree to use acceptable contraception * Symptoms of overactive bladder with urinary urgency incontinence * Inadequate response or limiting side effects with anticholinergics for the treatment of OAB Exclusion Cri...

Countries:United StatesFranceNetherlandsCzechiaGermanyPoland
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Frequently asked questions about AGN-214868

What is AGN-214868 used for?

AGN-214868 is an investigational small molecule being studied for postherpetic neuralgia and overactive bladder with urinary incontinence. It is in Phase 2 clinical development and is not approved by the FDA.

Who makes AGN-214868?

AGN-214868 is being developed by AbbVie Inc., traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 2 clinical trials.

What phase is AGN-214868 in?

AGN-214868 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in postherpetic neuralgia and one in overactive bladder. The drug is investigational and not yet approved.

What clinical trials is AGN-214868 in?

AGN-214868 has completed two Phase 2 trials. NCT01129531 studied the drug in 294 patients with postherpetic neuralgia in the US, Czechia, Germany, and Poland. NCT01157377 studied it in 160 patients with overactive bladder in the US, France, and the Netherlands.

Is AGN-214868 the same as another drug?

AGN-214868 is the primary name for this investigational compound. No alternative names have been reported in clinical trial records. It is a small molecule being developed by AbbVie for pain and urological conditions.