A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia

NCT ID: NCT01678924

Last Updated: 2020-01-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-09-30

Brief Summary

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This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).

Detailed Description

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Conditions

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Neuralgia, Postherpetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AGN-214868 Dose 1

AGN-214868 Dose 1 given as injections into the area of pain on Day 1.

Group Type EXPERIMENTAL

AGN-214868

Intervention Type DRUG

AGN-214868 given as injections into the area of pain on Day 1.

AGN-214868 Dose 2

AGN-214868 Dose 2 given as injections into the area of pain on Day 1.

Group Type EXPERIMENTAL

AGN-214868

Intervention Type DRUG

AGN-214868 given as injections into the area of pain on Day 1.

AGN-214868 Placebo (Vehicle)

AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.

Group Type PLACEBO_COMPARATOR

AGN-214868 Placebo (Vehicle)

Intervention Type DRUG

AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.

AGN-214868 Dose 3

AGN-214868 Dose 3 given as injections into the area of pain on Day 1.

Group Type EXPERIMENTAL

AGN-214868

Intervention Type DRUG

AGN-214868 given as injections into the area of pain on Day 1.

Interventions

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AGN-214868

AGN-214868 given as injections into the area of pain on Day 1.

Intervention Type DRUG

AGN-214868 Placebo (Vehicle)

AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postherpetic neuralgia with pain present for at least 9 months

Exclusion Criteria

* 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 capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Agave Clinical Research, LLC

Mesa, Arizona, United States

Site Status

Territory Neurology & Research Institute

Tucson, Arizona, United States

Site Status

Neuro-Pain Medical Center

Fresno, California, United States

Site Status

University of California, Irvine

Irvine, California, United States

Site Status

Loma Linda University

Loma Linda, California, United States

Site Status

Northern California Research Corp

Sacramento, California, United States

Site Status

Neurological Research Institute

Santa Monica, California, United States

Site Status

Alpine Clinical Research Center

Boulder, Colorado, United States

Site Status

The Mile High Research Center

Denver, Colorado, United States

Site Status

Riverside Clinical Research

Edgewater, Florida, United States

Site Status

Compass Research, LLC

Orlando, Florida, United States

Site Status

Drug Studies America

Marietta, Georgia, United States

Site Status

Injury Care Research, LLC

Boise, Idaho, United States

Site Status

Millennium Pain Center

Bloomington, Illinois, United States

Site Status

Beacon Clinical Research

Brockton, Massachusetts, United States

Site Status

Springfield Neurology Associates, LLC

Springfield, Massachusetts, United States

Site Status

Michigan Head Pain and Neurology Institute

Ann Arbor, Michigan, United States

Site Status

Quest Research Institute

Farmington Hills, Michigan, United States

Site Status

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

Clinvest Headache Care Center

Springfield, Missouri, United States

Site Status

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, United States

Site Status

The Medical Research Network, LLC

New York, New York, United States

Site Status

Island Neurological Associates, P.C.

Plainview, New York, United States

Site Status

Wake Research Associates

Raleigh, North Carolina, United States

Site Status

Plains Medical Clinic

Fargo, North Dakota, United States

Site Status

COR Clinical Research, LLC

Oklahoma City, Oklahoma, United States

Site Status

Allegheny Pain Management

Altoona, Pennsylvania, United States

Site Status

Omega Medical Research

Warwick, Rhode Island, United States

Site Status

Clinical Trials of South Carolina, LLC

Charleston, South Carolina, United States

Site Status

PharmaCorp Clinical Trials, Inc

Charleston, South Carolina, United States

Site Status

Clinical Research of Charleston

Mt. Pleasant, South Carolina, United States

Site Status

Center for Clinical Studies

Webster, Texas, United States

Site Status

MultiCare Neuroscience Center of Washington

Tacoma, Washington, United States

Site Status

AKH Wien

Vienna, , Austria

Site Status

Wilhelminenspital der Stadt Wien

Vienna, , Austria

Site Status

SMZ-Ost Donauspital

Vienna, , Austria

Site Status

Pro scientia med im MARE Klinikum

Kiel, Schleswig-Holstein, Germany

Site Status

Berlin Research Centre

Berlin, , Germany

Site Status

Regionales Schmerzzentrum DGS

Bielefeld, , Germany

Site Status

Bochum Research Centre

Bochum, , Germany

Site Status

Das Schmerzzentrum Celle

Celle, , Germany

Site Status

Ambulant study centre

Cologne, , Germany

Site Status

Leiter des Universitats Schmerz Centrums (USC)

Dresden, , Germany

Site Status

Neuro-Consil GmbH

Düsseldorf, , Germany

Site Status

Frankfurt Research Centre

Frankfurt, , Germany

Site Status

Schmerz und Palliativzentrum Fulda

Fulda, , Germany

Site Status

Schmerz und Palliativ- Zentrum Goeppingen

Göppingen, , Germany

Site Status

Klinikum Hanau GmbH

Hanau, , Germany

Site Status

Neurologische Praxis Heidenheim

Heidenheim, , Germany

Site Status

Facharzt fur Neurologie

Hoppegarten, , Germany

Site Status

Schmerzklinik Kiel

Kiel, , Germany

Site Status

Medamed GmbH

Leipzig, , Germany

Site Status

Leipzig Research Centre

Leipzig, , Germany

Site Status

Magdeburg Research Centre

Magdeburg, , Germany

Site Status

Regionales Schmerz- und Palliativ Zentrum DGS Mainz

Mainz, , Germany

Site Status

Universitätsklinik Ulm

Ulm, , Germany

Site Status

Schmerztherapiezentrum Villingen-Schwenningen

Villingen-Schwenningen, , Germany

Site Status

Poznański Ośrodek Medyczny NOVAMED

Poznan, Poznañ, Poland

Site Status

Medica Pro Familia Sp. Z.o.o SKA

Gdynia, , Poland

Site Status

Medica Pro Familia Sp. Z.o.o SKA

Katowice, , Poland

Site Status

Malopolskie Centrum Medyczne S.C.

Krakow, , Poland

Site Status

Specjalistyczny Gabinet Neurologiczny

Krakow, , Poland

Site Status

Nzoz Neuromed

Lublin, , Poland

Site Status

NZOZ Neuro-Kard

Poznan, , Poland

Site Status

Osrodek Badan Klinicznych Euromedis Sp. z o.o.

Szczecin, , Poland

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej

Świdnik, , Poland

Site Status

Przychodnia Specjalistyczna PROSEN

Warsaw, , Poland

Site Status

Medica Pro Familia Warszawa

Warsaw, , Poland

Site Status

Synexus SCM sp. z o.o.

Wroclaw, , Poland

Site Status

Countries

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United States Austria Germany Poland

Other Identifiers

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2012-002240-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

214868-007

Identifier Type: -

Identifier Source: org_study_id

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