Suspended
A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
What is being tested
AGN-214868
+ AGN-214868
+ AGN-214868 Placebo (Vehicle)
Drug
Who is being recruted
Nervous System Diseases+6
+ Neuralgia
+ Neurologic Manifestations
From 18 to 80 Years
+6 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: January 2013
Summary
Principal SponsorAllergan
Last updated: January 7, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2013
Actual date on which the first participant was enrolled.This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
Principal SponsorAllergan
Last updated: January 7, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
280 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Nervous System DiseasesNeuralgiaNeurologic ManifestationsNeuromuscular DiseasesPainPeripheral Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeuralgia, Postherpetic
Criteria
1 inclusion criteria required to participate
Postherpetic neuralgia with pain present for at least 9 months
5 exclusion criteria prevent from participating
Active herpes zoster skin rash
Anticipated treatment for postherpetic neuralgia during the first 3 months of the study, including oral and topical medications, acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS), or trigger point injection
Anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the first 3 months of the study
Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalAGN-214868 Dose 1 given as injections into the area of pain on Day 1.
Group II
ExperimentalAGN-214868 Dose 2 given as injections into the area of pain on Day 1.
Group III
PlaceboAGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
Group IV
ExperimentalAGN-214868 Dose 3 given as injections into the area of pain on Day 1.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 69 locations
Territory Neurology & Research Institute
Tucson, United StatesNeuro-Pain Medical Center
Fresno, United StatesUniversity of California, Irvine
Irvine, United StatesSuspended69 Study Centers