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

NCT01678924 | Terminated Phase 2 Results DMC

• 2 other identifiers: 214868-0072012-002240-24
• Study Type: interventional
• Target: 280
• Locations: 4 countries
• Sites: 69

Brief Summary

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

Conditions

Neuralgia, Postherpetic

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Average Pain Intensity Score - Cohort 1

  The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.

  Baseline to Week 12

• Change From Baseline in Average Pain Intensity Score - Cohort 2

  The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.

  Baseline to Week 12

Secondary Outcomes (48)

• Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1

  Baseline to Week 1

• Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2

  Baseline to Week 2

• Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3

  Baseline to Week 3

• Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4

  Baseline to Week 4

• Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5

  Baseline to Week 5

Study Arms (4)

AGN-214868 Dose 1

EXPERIMENTAL

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

Drug: AGN-214868

AGN-214868 Dose 2

EXPERIMENTAL

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

Drug: AGN-214868

AGN-214868 Placebo (Vehicle)

PLACEBO COMPARATOR

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

Drug: AGN-214868 Placebo (Vehicle)

AGN-214868 Dose 3

EXPERIMENTAL

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

Drug: AGN-214868

Interventions

AGN-214868 DRUG

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

AGN-214868 Dose 1; AGN-214868 Dose 2; AGN-214868 Dose 3

AGN-214868 Placebo (Vehicle) DRUG

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

AGN-214868 Placebo (Vehicle)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postherpetic neuralgia with pain present for at least 9 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (69)

Agave Clinical Research, LLC

Mesa, Arizona, 85202, United States

Location

Territory Neurology & Research Institute

Tucson, Arizona, 85704, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

Northern California Research Corp

Sacramento, California, 95821, United States

Location

Neurological Research Institute

Santa Monica, California, 90404, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80301, United States

Location

The Mile High Research Center

Denver, Colorado, 80218, United States

Location

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Injury Care Research, LLC

Boise, Idaho, 83713, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Beacon Clinical Research

Brockton, Massachusetts, 02301, United States

Location

Springfield Neurology Associates, LLC

Springfield, Massachusetts, 01104, United States

Location

Michigan Head Pain and Neurology Institute

Ann Arbor, Michigan, 48104, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Clinvest Headache Care Center

Springfield, Missouri, 65807, United States

Location

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, 87109, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Island Neurological Associates, P.C.

Plainview, New York, 11803-4491, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Plains Medical Clinic

Fargo, North Dakota, 58104, United States

Location

COR Clinical Research, LLC

Oklahoma City, Oklahoma, 73103, United States

Location

Allegheny Pain Management

Altoona, Pennsylvania, 16602, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Clinical Trials of South Carolina, LLC

Charleston, South Carolina, 29406, United States

Location

PharmaCorp Clinical Trials, Inc

Charleston, South Carolina, 29412, United States

Location

Clinical Research of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

MultiCare Neuroscience Center of Washington

Tacoma, Washington, 98405, United States

Location

AKH Wien

Vienna, 1090, Austria

Location

Wilhelminenspital der Stadt Wien

Vienna, 1160, Austria

Location

SMZ-Ost Donauspital

Vienna, A-1220, Austria

Location

Pro scientia med im MARE Klinikum

Kiel, Schleswig-Holstein, 24119, Germany

Location

Berlin Research Centre

Berlin, 12627, Germany

Location

Regionales Schmerzzentrum DGS

Bielefeld, 33602, Germany

Location

Bochum Research Centre

Bochum, 44787, Germany

Location

Das Schmerzzentrum Celle

Celle, 29221, Germany

Location

Ambulant study centre

Cologne, 50935, Germany

Location

Leiter des Universitats Schmerz Centrums (USC)

Dresden, 01307, Germany

Location

Neuro-Consil GmbH

Düsseldorf, D-40212, Germany

Location

Frankfurt Research Centre

Frankfurt, 60596, Germany

Location

Schmerz und Palliativzentrum Fulda

Fulda, 36039, Germany

Location

Schmerz und Palliativ- Zentrum Goeppingen

Göppingen, 73033, Germany

Location

Klinikum Hanau GmbH

Hanau, 63450, Germany

Location

Neurologische Praxis Heidenheim

Heidenheim, 89518, Germany

Location

Facharzt fur Neurologie

Hoppegarten, 15366, Germany

Location

Schmerzklinik Kiel

Kiel, 24149, Germany

Location

Medamed GmbH

Leipzig, 04109, Germany

Location

Leipzig Research Centre

Leipzig, D-04103, Germany

Location

Magdeburg Research Centre

Magdeburg, 39104, Germany

Location

Regionales Schmerz- und Palliativ Zentrum DGS Mainz

Mainz, 55116, Germany

Location

Universitätsklinik Ulm

Ulm, 89081, Germany

Location

Schmerztherapiezentrum Villingen-Schwenningen

Villingen-Schwenningen, D-78052, Germany

Location

Poznański Ośrodek Medyczny NOVAMED

Poznan, Poznañ, 60-773, Poland

Location

Medica Pro Familia Sp. Z.o.o SKA

Gdynia, 81338, Poland

Location

Medica Pro Familia Sp. Z.o.o SKA

Katowice, 40-954, Poland

Location

Malopolskie Centrum Medyczne S.C.

Krakow, 30-510, Poland

Location

Specjalistyczny Gabinet Neurologiczny

Krakow, 30-539, Poland

Location

Nzoz Neuromed

Lublin, 20-064, Poland

Location

NZOZ Neuro-Kard

Poznan, 61-853, Poland

Location

Osrodek Badan Klinicznych Euromedis Sp. z o.o.

Szczecin, 70-111, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej

Świdnik, 21-040, Poland

Location

Przychodnia Specjalistyczna PROSEN

Warsaw, 01-231, Poland

Location

Medica Pro Familia Warszawa

Warsaw, 01-868, Poland

Location

Synexus SCM sp. z o.o.

Wroclaw, 50-088, Poland

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan plc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: January 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 7, 2020
• Results First Posted: January 7, 2020

Record last verified: 2019-12

Locations

PL (12); US (33); AU (3); DE (21)