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

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

Study Overview

• Status: Terminated
• Conditions: Neuralgia, Postherpetic
• Intervention / Treatment: Drug: AGN-214868; Drug: AGN-214868 Placebo (Vehicle)

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1220
    • SMZ-Ost Donauspital
  • Wien, Austria, 1090
    • AKH Wien
  • Wien, Austria, 1160
    • Wilhelminenspital der Stadt Wien
• Germany
  • Berlin, Germany, 12627
    • Berlin Research Centre
  • Bielefeld, Germany, 33602
    • Regionales Schmerzzentrum DGS
  • Bochum, Germany, 44787
    • Bochum Research Centre
  • Celle, Germany, 29221
    • Das Schmerzzentrum Celle
  • Cologne, Germany, 50935
    • Ambulant study centre
  • Dresden, Germany, 01307
    • Leiter des Universitats Schmerz Centrums (USC)
  • Düsseldorf, Germany, D-40212
    • Neuro-Consil Gmbh
  • Frankfurt, Germany, 60596
    • Frankfurt Research Centre
  • Fulda, Germany, 36039
    • Schmerz und Palliativzentrum Fulda
  • Goeppingen, Germany, 73033
    • Schmerz und Palliativ- Zentrum Goeppingen
  • Hanau, Germany, 63450
    • Klinikum Hanau GmbH
  • Heidenheim, Germany, 89518
    • Neurologische Praxis Heidenheim
  • Hoppegarten, Germany, 15366
    • Facharzt fur Neurologie
  • Kiel, Germany, 24149
    • Schmerzklinik Kiel
  • Leipzig, Germany, 04109
    • Medamed GmbH
  • Leipzig, Germany, D-04103
    • Leipzig Research Centre
  • Magdeburg, Germany, 39104
    • Magdeburg Research Centre
  • Mainz, Germany, 55116
    • Regionales Schmerz- und Palliativ Zentrum DGS Mainz
  • Ulm, Germany, 89081
    • Universitätsklinik Ulm
  • Villingen-Schwenningen, Germany, D-78052
    • Schmerztherapiezentrum Villingen-Schwenningen
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24119
      • pro scientia med im MARE Klinikum
• Poland
  • Gdynia, Poland, 81338
    • Medica Pro Familia Sp. Z.o.o SKA
  • Katowice, Poland, 40-954
    • Medica Pro Familia Sp. Z.o.o SKA
  • Krakow, Poland, 30-510
    • Malopolskie Centrum Medyczne s.c.
  • Krakow, Poland, 30-539
    • Specjalistyczny Gabinet Neurologiczny
  • Lublin, Poland, 20-064
    • Nzoz Neuromed
  • Poznan, Poland, 61-853
    • NZOZ Neuro-kard
  • Swidnik, Poland, 21-040
    • Niepubliczny Zaklad Opieki Zdrowotnej
  • Szczecin, Poland, 70-111
    • Osrodek Badan Klinicznych Euromedis Sp. z o.o.
  • Warszawa, Poland, 01-231
    • Przychodnia Specjalistyczna PROSEN
  • Warszawa, Poland, 01-868
    • Medica Pro Familia Warszawa
  • Wroclaw, Poland, 50-088
    • Synexus SCM Sp. z o.o.
  • Poznañ
    • Poznan, Poznañ, Poland, 60-773
      • Poznański Ośrodek Medyczny NOVAMED
• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Agave Clinical Research, LLC
    • Tucson, Arizona, United States, 85704
      • Territory Neurology & Research Institute
  • California
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center
    • Irvine, California, United States, 92697
      • University of California, Irvine
    • Loma Linda, California, United States, 92354
      • Loma Linda University
    • Sacramento, California, United States, 95821
      • Northern California Research Corp
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
    • Denver, Colorado, United States, 80218
      • The Mile High Research Center
  • Florida
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
  • Idaho
    • Boise, Idaho, United States, 83713
      • Injury Care Research, LLC
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Millennium Pain Center
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research
    • Springfield, Massachusetts, United States, 01104
      • Springfield Neurology Associates, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain and Neurology Institute
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center for Pharmaceutical Research
    • Springfield, Missouri, United States, 65807
      • Clinvest Headache Care Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience, Inc.
  • New York
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • Plainview, New York, United States, 11803-4491
      • Island Neurological Associates, P.C.
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Medical Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research, LLC
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Allegheny Pain Management
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Pharmacorp Clinical Trials, INC
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina, LLC
    • Mount Pleasant, South Carolina, United States, 29464
      • Clinical Research of Charleston
  • Texas
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Washington
    • Tacoma, Washington, United States, 98405
      • Multicare Neuroscience Center of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AGN-214868 Dose 1; AGN-214868 Dose 1 given as injections into the area of pain on Day 1.	Drug: AGN-214868; AGN-214868 given as injections into the area of pain on Day 1.
EXPERIMENTAL: AGN-214868 Dose 2; AGN-214868 Dose 2 given as injections into the area of pain on Day 1.	Drug: AGN-214868; AGN-214868 given as injections into the area of pain on Day 1.
PLACEBO_COMPARATOR: AGN-214868 Placebo (Vehicle); AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.	Drug: AGN-214868 Placebo (Vehicle); AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
EXPERIMENTAL: AGN-214868 Dose 3; AGN-214868 Dose 3 given as injections into the area of pain on Day 1.	Drug: AGN-214868; AGN-214868 given as injections into the area of pain on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 1
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 2
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 3
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline	Baseline to Week 4
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 5
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 6
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 7
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 8
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 9
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 10
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 11
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 12
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 1
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 2
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 3
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 4
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 5
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 6
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 7
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 8
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 9
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 10
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 11
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 12
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient and that the patient was asked to circle their MASP on with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 2
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 4
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 8
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 12
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 2
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 4
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 8
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 12
Change From Baseline in Area of Allodynia - Cohort 1 - Week 2	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 2
Change From Baseline in Area of Allodynia - Cohort 1 - Week 4	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 4
Change From Baseline in Area of Allodynia - Cohort 1 - Week 8	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 8
Change From Baseline in Area of Allodynia - Cohort 1 - Week 12	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 12
Change From Baseline in Area of Allodynia - Cohort 2 - Week 2	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 2
Change From Baseline in Area of Allodynia - Cohort 2 - Week 4	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 4
Change From Baseline in Area of Allodynia - Cohort 2 - Week 8	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 8
Change From Baseline in Area of Allodynia - Cohort 2 - Week 12	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 12
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 2
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 4
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 8
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 12
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 2
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 4
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 8
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: August 31, 2012
• First Submitted That Met QC Criteria: August 31, 2012
• First Posted (ESTIMATE): September 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: 214868-007; 2012-002240-24 (EUDRACT_NUMBER)