A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
Primary Purpose
Neuralgia, Postherpetic
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AGN-214868
AGN-214868 Placebo (Vehicle)
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia, Postherpetic
Eligibility Criteria
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
Sites / Locations
- Agave Clinical Research, LLC
- Territory Neurology & Research Institute
- Neuro-Pain Medical Center
- University of California, Irvine
- Loma Linda University
- Northern California Research Corp
- Neurological Research Institute
- Alpine Clinical Research Center
- The Mile High Research Center
- Riverside Clinical Research
- Compass Research, LLC
- Drug Studies America
- Injury Care Research, LLC
- Millennium Pain Center
- Beacon Clinical Research
- Springfield Neurology Associates, LLC
- Michigan Head Pain and Neurology Institute
- Quest Research Institute
- Center for Pharmaceutical Research
- Clinvest Headache Care Center
- Albuquerque Neuroscience, Inc.
- The Medical Research Network, LLC
- Island Neurological Associates, P.C.
- Wake Research Associates
- Plains Medical Clinic
- COR Clinical Research, LLC
- Allegheny Pain Management
- Omega Medical Research
- Clinical Trials of South Carolina, LLC
- PharmaCorp Clinical Trials, Inc
- Clinical Research of Charleston
- Center for Clinical Studies
- MultiCare Neuroscience Center of Washington
- SMZ-Ost Donauspital
- AKH Wien
- Wilhelminenspital der Stadt Wien
- Pro scientia med im MARE Klinikum
- Berlin Research Centre
- Regionales Schmerzzentrum DGS
- Bochum Research Centre
- Das Schmerzzentrum Celle
- Ambulant study centre
- Leiter des Universitats Schmerz Centrums (USC)
- Neuro-Consil GmbH
- Frankfurt Research Centre
- Schmerz und Palliativzentrum Fulda
- Schmerz und Palliativ- Zentrum Goeppingen
- Klinikum Hanau GmbH
- Neurologische Praxis Heidenheim
- Facharzt fur Neurologie
- Schmerzklinik Kiel
- Medamed GmbH
- Leipzig Research Centre
- Magdeburg Research Centre
- Regionales Schmerz- und Palliativ Zentrum DGS Mainz
- Universitätsklinik Ulm
- Schmerztherapiezentrum Villingen-Schwenningen
- Poznański Ośrodek Medyczny NOVAMED
- Medica Pro Familia Sp. Z.o.o SKA
- Medica Pro Familia Sp. Z.o.o SKA
- Malopolskie Centrum Medyczne S.C.
- Specjalistyczny Gabinet Neurologiczny
- Nzoz Neuromed
- NZOZ Neuro-Kard
- Niepubliczny Zaklad Opieki Zdrowotnej
- Osrodek Badan Klinicznych Euromedis Sp. z o.o.
- Przychodnia Specjalistyczna PROSEN
- Medica Pro Familia Warszawa
- Synexus SCM sp. z o.o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
AGN-214868 Dose 1
AGN-214868 Dose 2
AGN-214868 Placebo (Vehicle)
AGN-214868 Dose 3
Arm Description
AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
AGN-214868 Dose 2 given as injections into the area of pain on Day 1.
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
AGN-214868 Dose 3 given as injections into the area of pain on Day 1.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01678924
Brief Title
A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Postherpetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN-214868 Dose 1
Arm Type
Experimental
Arm Description
AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
Arm Title
AGN-214868 Dose 2
Arm Type
Experimental
Arm Description
AGN-214868 Dose 2 given as injections into the area of pain on Day 1.
Arm Title
AGN-214868 Placebo (Vehicle)
Arm Type
Placebo Comparator
Arm Description
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
Arm Title
AGN-214868 Dose 3
Arm Type
Experimental
Arm Description
AGN-214868 Dose 3 given as injections into the area of pain on Day 1.
Intervention Type
Drug
Intervention Name(s)
AGN-214868
Intervention Description
AGN-214868 given as injections into the area of pain on Day 1.
Intervention Type
Drug
Intervention Name(s)
AGN-214868 Placebo (Vehicle)
Intervention Description
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
Primary Outcome Measure Information:
Title
Change From Baseline in Average Pain Intensity Score - Cohort 1
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Average Pain Intensity Score - Cohort 2
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1
Description
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
Time Frame
Baseline to Week 1
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2
Description
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
Time Frame
Baseline to Week 2
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3
Description
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
Time Frame
Baseline to Week 3
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4
Description
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
Time Frame
Baseline to Week 4
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5
Description
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
Time Frame
Baseline to Week 5
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6
Description
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
Time Frame
Baseline to Week 6
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7
Description
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
Time Frame
Baseline to Week 7
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8
Description
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
Time Frame
Baseline to Week 8
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9
Description
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
Time Frame
Baseline to Week 9
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10
Description
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
Time Frame
Baseline to Week 10
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11
Description
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
Time Frame
Baseline to Week 11
Title
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12
Description
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
Time Frame
Baseline to Week 12
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1
Description
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
Time Frame
Baseline to Week 1
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2
Description
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
Time Frame
Baseline to Week 2
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3
Description
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
Time Frame
Baseline to Week 3
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4
Description
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
Time Frame
Baseline to Week 4
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5
Description
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
Time Frame
Baseline to Week 5
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6
Description
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
Time Frame
Baseline to Week 6
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7
Description
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
Time Frame
Baseline to Week 7
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8
Description
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
Time Frame
Baseline to Week 8
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9
Description
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
Time Frame
Baseline to Week 9
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10
Description
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
Time Frame
Baseline to Week 10
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11
Description
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
Time Frame
Baseline to Week 11
Title
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12
Description
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
Time Frame
Baseline to Week 12
Title
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2
Description
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.
Time Frame
Baseline to Week 2
Title
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8
Description
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.
Time Frame
Baseline to Week 8
Title
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2
Description
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.
Time Frame
Baseline to Week 2
Title
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8
Description
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.
Time Frame
Baseline to Week 8
Title
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Area of Allodynia - Cohort 1 - Week 2
Description
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.
Time Frame
Baseline to Week 2
Title
Change From Baseline in Area of Allodynia - Cohort 1 - Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline in Area of Allodynia - Cohort 1 - Week 8
Description
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.
Time Frame
Baseline to Week 8
Title
Change From Baseline in Area of Allodynia - Cohort 1 - Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Area of Allodynia - Cohort 2 - Week 2
Description
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.
Time Frame
Baseline to Week 2
Title
Change From Baseline in Area of Allodynia - Cohort 2 - Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline in Area of Allodynia - Cohort 2 - Week 8
Description
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.
Time Frame
Baseline to Week 8
Title
Change From Baseline in Area of Allodynia - Cohort 2 - Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2
Description
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.
Time Frame
Baseline to Week 2
Title
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8
Description
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.
Time Frame
Baseline to Week 8
Title
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2
Description
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.
Time Frame
Baseline to Week 2
Title
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8
Description
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.
Time Frame
Baseline to Week 8
Title
Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12
Description
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.
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Agave Clinical Research, LLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Territory Neurology & Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Northern California Research Corp
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
The Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Injury Care Research, LLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Beacon Clinical Research
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Springfield Neurology Associates, LLC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Michigan Head Pain and Neurology Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Clinvest Headache Care Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Island Neurological Associates, P.C.
City
Plainview
State/Province
New York
ZIP/Postal Code
11803-4491
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Plains Medical Clinic
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
COR Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Allegheny Pain Management
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Clinical Trials of South Carolina, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
PharmaCorp Clinical Trials, Inc
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Clinical Research of Charleston
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
MultiCare Neuroscience Center of Washington
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
SMZ-Ost Donauspital
City
Vienna
ZIP/Postal Code
A-1220
Country
Austria
Facility Name
AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminenspital der Stadt Wien
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Pro scientia med im MARE Klinikum
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24119
Country
Germany
Facility Name
Berlin Research Centre
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Regionales Schmerzzentrum DGS
City
Bielefeld
ZIP/Postal Code
33602
Country
Germany
Facility Name
Bochum Research Centre
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Das Schmerzzentrum Celle
City
Celle
ZIP/Postal Code
29221
Country
Germany
Facility Name
Ambulant study centre
City
Cologne
ZIP/Postal Code
50935
Country
Germany
Facility Name
Leiter des Universitats Schmerz Centrums (USC)
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Neuro-Consil GmbH
City
Düsseldorf
ZIP/Postal Code
D-40212
Country
Germany
Facility Name
Frankfurt Research Centre
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Schmerz und Palliativzentrum Fulda
City
Fulda
ZIP/Postal Code
36039
Country
Germany
Facility Name
Schmerz und Palliativ- Zentrum Goeppingen
City
Goeppingen
ZIP/Postal Code
73033
Country
Germany
Facility Name
Klinikum Hanau GmbH
City
Hanau
ZIP/Postal Code
63450
Country
Germany
Facility Name
Neurologische Praxis Heidenheim
City
Heidenheim
ZIP/Postal Code
89518
Country
Germany
Facility Name
Facharzt fur Neurologie
City
Hoppegarten
ZIP/Postal Code
15366
Country
Germany
Facility Name
Schmerzklinik Kiel
City
Kiel
ZIP/Postal Code
24149
Country
Germany
Facility Name
Medamed GmbH
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
Facility Name
Leipzig Research Centre
City
Leipzig
ZIP/Postal Code
D-04103
Country
Germany
Facility Name
Magdeburg Research Centre
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Regionales Schmerz- und Palliativ Zentrum DGS Mainz
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Universitätsklinik Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Schmerztherapiezentrum Villingen-Schwenningen
City
Villingen-Schwenningen
ZIP/Postal Code
D-78052
Country
Germany
Facility Name
Poznański Ośrodek Medyczny NOVAMED
City
Poznan
State/Province
Poznañ
ZIP/Postal Code
60-773
Country
Poland
Facility Name
Medica Pro Familia Sp. Z.o.o SKA
City
Gdynia
ZIP/Postal Code
81338
Country
Poland
Facility Name
Medica Pro Familia Sp. Z.o.o SKA
City
Katowice
ZIP/Postal Code
40-954
Country
Poland
Facility Name
Malopolskie Centrum Medyczne S.C.
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Specjalistyczny Gabinet Neurologiczny
City
Krakow
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Nzoz Neuromed
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
NZOZ Neuro-Kard
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Osrodek Badan Klinicznych Euromedis Sp. z o.o.
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Przychodnia Specjalistyczna PROSEN
City
Warszawa
ZIP/Postal Code
01-231
Country
Poland
Facility Name
Medica Pro Familia Warszawa
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Synexus SCM sp. z o.o.
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
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