A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
- Conditions
- Neuralgia, Postherpetic
- Interventions
- Drug: AGN-214868Drug: AGN-214868 Placebo (Vehicle)
- Registration Number
- NCT01678924
- Lead Sponsor
- Allergan
- Brief Summary
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 280
- Postherpetic neuralgia with pain present for at least 9 months
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGN-214868 Dose 2 AGN-214868 AGN-214868 Dose 2 given as injections into the area of pain on Day 1. AGN-214868 Placebo (Vehicle) AGN-214868 Placebo (Vehicle) AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1. AGN-214868 Dose 3 AGN-214868 AGN-214868 Dose 3 given as injections into the area of pain on Day 1. AGN-214868 Dose 1 AGN-214868 AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
- Primary Outcome Measures
Name Time Method Change From Baseline in Average Pain Intensity Score - Cohort 1 Baseline to Week 12 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 Baseline to Week 12 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
Name Time Method Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 Baseline to 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 3 Baseline to 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 Baseline to 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 2 Baseline to 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 9 Baseline to 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 2 Baseline to 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 4 Baseline to 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 1 - Week 5 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 10 Baseline to 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 1 Baseline to 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 3 Baseline to 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 11 Baseline to 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 Baseline to 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 12 Baseline to 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 Baseline to 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 Baseline to 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.
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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
Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12 Baseline to 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 8 Baseline to 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.
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 Area of Allodynia - Cohort 2 - Week 8 Baseline to 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 Baseline to 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 Baseline to 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 Maximal Area of Spontaneous Pain - Cohort 2 - Week 8 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 Baseline to 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 Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4 Baseline to 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 Baseline to 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 4 Baseline to 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 12 Baseline to 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 Baseline to 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.
Trial Locations
- Locations (68)
NZOZ Neuro-Kard
🇵🇱Poznan, Poland
University of California, Irvine
🇺🇸Irvine, California, United States
Wilhelminenspital der Stadt Wien
🇦🇹Wien, Austria
Schmerzklinik Kiel
🇩🇪Kiel, Germany
Bochum Research Centre
🇩🇪Bochum, Germany
Beacon Clinical Research
🇺🇸Brockton, Massachusetts, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Frankfurt Research Centre
🇩🇪Frankfurt, Germany
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Nzoz Neuromed
🇵🇱Lublin, Poland
Springfield Neurology Associates, LLC
🇺🇸Springfield, Massachusetts, United States
Das Schmerzzentrum Celle
🇩🇪Celle, Germany
Plains Medical Clinic
🇺🇸Fargo, North Dakota, United States
Klinikum Hanau GmbH
🇩🇪Hanau, Germany
Medica Pro Familia Sp. Z.o.o SKA
🇵🇱Katowice, Poland
Territory Neurology & Research Institute
🇺🇸Tucson, Arizona, United States
Millennium Pain Center
🇺🇸Bloomington, Illinois, United States
Ambulant study centre
🇩🇪Cologne, Germany
Facharzt fur Neurologie
🇩🇪Hoppegarten, Germany
SMZ-Ost Donauspital
🇦🇹Vienna, Austria
Osrodek Badan Klinicznych Euromedis Sp. z o.o.
🇵🇱Szczecin, Poland
Medica Pro Familia Warszawa
🇵🇱Warszawa, Poland
Injury Care Research, LLC
🇺🇸Boise, Idaho, United States
Regionales Schmerz- und Palliativ Zentrum DGS Mainz
🇩🇪Mainz, Germany
Neuro-Consil GmbH
🇩🇪Düsseldorf, Germany
Magdeburg Research Centre
🇩🇪Magdeburg, Germany
Poznański Ośrodek Medyczny NOVAMED
🇵🇱Poznan, Poznañ, Poland
Malopolskie Centrum Medyczne S.C.
🇵🇱Krakow, Poland
Clinical Research of Charleston
🇺🇸Mount Pleasant, South Carolina, United States
Neurologische Praxis Heidenheim
🇩🇪Heidenheim, Germany
Schmerz und Palliativ- Zentrum Goeppingen
🇩🇪Goeppingen, Germany
Regionales Schmerzzentrum DGS
🇩🇪Bielefeld, Germany
Niepubliczny Zaklad Opieki Zdrowotnej
🇵🇱Swidnik, Poland
Pro scientia med im MARE Klinikum
🇩🇪Kiel, Schleswig-Holstein, Germany
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Schmerztherapiezentrum Villingen-Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Agave Clinical Research, LLC
🇺🇸Mesa, Arizona, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Quest Research Institute
🇺🇸Farmington Hills, Michigan, United States
AKH Wien
🇦🇹Wien, Austria
Clinvest Headache Care Center
🇺🇸Springfield, Missouri, United States
MultiCare Neuroscience Center of Washington
🇺🇸Tacoma, Washington, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Allegheny Pain Management
🇺🇸Altoona, Pennsylvania, United States
Leiter des Universitats Schmerz Centrums (USC)
🇩🇪Dresden, Germany
Schmerz und Palliativzentrum Fulda
🇩🇪Fulda, Germany
Specjalistyczny Gabinet Neurologiczny
🇵🇱Krakow, Poland
Medamed GmbH
🇩🇪Leipzig, Germany
Przychodnia Specjalistyczna PROSEN
🇵🇱Warszawa, Poland
Synexus SCM sp. z o.o.
🇵🇱Wroclaw, Poland
Loma Linda University
🇺🇸Loma Linda, California, United States
Island Neurological Associates, P.C.
🇺🇸Plainview, New York, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Leipzig Research Centre
🇩🇪Leipzig, Germany
Berlin Research Centre
🇩🇪Berlin, Germany
Universitätsklinik Ulm
🇩🇪Ulm, Germany
Northern California Research Corp
🇺🇸Sacramento, California, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Michigan Head Pain and Neurology Institute
🇺🇸Ann Arbor, Michigan, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Clinical Trials of South Carolina, LLC
🇺🇸Charleston, South Carolina, United States
The Mile High Research Center
🇺🇸Denver, Colorado, United States
PharmaCorp Clinical Trials, Inc
🇺🇸Charleston, South Carolina, United States