Neuralgia, PostherpeticPhase 2NCT01678924
A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
A Phase 2 study testing AGN-214868 in people with Neuralgia, Postherpetic, run by Allergan at 69 sites in 4 countries.
Trial summary
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuralgia, Postherpetic
- What is being tested?
- AGN-214868
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 69 sitesin 4 countries
- Study dates
- Jan 2013to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postherpetic neuralgia with pain present for at least 9 months
Who cannot join
- 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
Trial locations and contacts
69 sites in 4 countries.
69 sites in 4 countries
United States33 sites
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109
Allegheny Pain Management
Altoona, Pennsylvania, 16602
Michigan Head Pain and Neurology Institute
Ann Arbor, Michigan, 48104
Millennium Pain Center
Bloomington, Illinois, 61701
Injury Care Research, LLC
Boise, Idaho, 83713
Alpine Clinical Research Center
Boulder, Colorado, 80301
Beacon Clinical Research
Brockton, Massachusetts, 02301
Clinical Trials of South Carolina, LLC
Charleston, South Carolina, 29406
PharmaCorp Clinical Trials, Inc
Charleston, South Carolina, 29412
The Mile High Research Center
Denver, Colorado, 80218
Riverside Clinical Research
Edgewater, Florida, 32132
Plains Medical Clinic
Fargo, North Dakota, 58104
Quest Research Institute
Farmington Hills, Michigan, 48334
Neuro-Pain Medical Center
Fresno, California, 93710
University of California, Irvine
Irvine, California, 92697
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Loma Linda University
Loma Linda, California, 92354
Drug Studies America
Marietta, Georgia, 30060
Agave Clinical Research, LLC
Mesa, Arizona, 85202
Clinical Research of Charleston
Mt. Pleasant, South Carolina, 29464
The Medical Research Network, LLC
New York, New York, 10128
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103
Compass Research, LLC
Orlando, Florida, 32806
Island Neurological Associates, P.C.
Plainview, New York, 11803-4491
Wake Research Associates
Raleigh, North Carolina, 27612
Northern California Research Corp
Sacramento, California, 95821
Neurological Research Institute
Santa Monica, California, 90404
Springfield Neurology Associates, LLC
Springfield, Massachusetts, 01104
Clinvest Headache Care Center
Springfield, Missouri, 65807
MultiCare Neuroscience Center of Washington
Tacoma, Washington, 98405
Territory Neurology & Research Institute
Tucson, Arizona, 85704
Omega Medical Research
Warwick, Rhode Island, 02886
Center for Clinical Studies
Webster, Texas, 77598
Germany21 sites
Berlin Research Centre
Berlin, 12627
Regionales Schmerzzentrum DGS
Bielefeld, 33602
Bochum Research Centre
Bochum, 44787
Das Schmerzzentrum Celle
Celle, 29221
Ambulant study centre
Cologne, 50935
Leiter des Universitats Schmerz Centrums (USC)
Dresden, 01307
Neuro-Consil GmbH
Düsseldorf, D-40212
Frankfurt Research Centre
Frankfurt, 60596
Schmerz und Palliativzentrum Fulda
Fulda, 36039
Schmerz und Palliativ- Zentrum Goeppingen
Göppingen, 73033
Klinikum Hanau GmbH
Hanau, 63450
Neurologische Praxis Heidenheim
Heidenheim, 89518
Facharzt fur Neurologie
Hoppegarten, 15366
Pro scientia med im MARE Klinikum
Kiel, Schleswig-Holstein, 24119
Schmerzklinik Kiel
Kiel, 24149
Medamed GmbH
Leipzig, 04109
Leipzig Research Centre
Leipzig, D-04103
Magdeburg Research Centre
Magdeburg, 39104
Regionales Schmerz- und Palliativ Zentrum DGS Mainz
Mainz, 55116
Universitätsklinik Ulm
Ulm, 89081
Schmerztherapiezentrum Villingen-Schwenningen
Villingen-Schwenningen, D-78052
Poland12 sites
Medica Pro Familia Sp. Z.o.o SKA
Gdynia, 81338
Medica Pro Familia Sp. Z.o.o SKA
Katowice, 40-954
Malopolskie Centrum Medyczne S.C.
Krakow, 30-510
Specjalistyczny Gabinet Neurologiczny
Krakow, 30-539
Nzoz Neuromed
Lublin, 20-064
Poznański Ośrodek Medyczny NOVAMED
Poznan, Poznañ, 60-773
NZOZ Neuro-Kard
Poznan, 61-853
Niepubliczny Zaklad Opieki Zdrowotnej
Świdnik, 21-040
Osrodek Badan Klinicznych Euromedis Sp. z o.o.
Szczecin, 70-111
Przychodnia Specjalistyczna PROSEN
Warsaw, 01-231
Medica Pro Familia Warszawa
Warsaw, 01-868
Synexus SCM sp. z o.o.
Wroclaw, 50-088
Austria3 sites
AKH Wien
Vienna, 1090
Wilhelminenspital der Stadt Wien
Vienna, 1160
SMZ-Ost Donauspital
Vienna, A-1220
About this study
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
- Conditions
- Neuralgia, Postherpetic
- Being tested
- AGN-214868, AGN-214868 Placebo (Vehicle)
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-214868Drug
AGN-214868 given as injections into the area of pain on Day 1.
AGN-214868 Placebo (Vehicle)Drug
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| AGN-214868 Dose 1 | Experimental | AGN-214868 Dose 1 given as injections into the area of pain on Day 1. Receives: Drug: AGN-214868 |
| AGN-214868 Dose 2 | Experimental | AGN-214868 Dose 2 given as injections into the area of pain on Day 1. Receives: Drug: AGN-214868 |
| AGN-214868 Placebo (Vehicle) | Placebo comparator | AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1. Receives: Drug: AGN-214868 Placebo (Vehicle) |
| AGN-214868 Dose 3 | Experimental | AGN-214868 Dose 3 given as injections into the area of pain on Day 1. Receives: Drug: AGN-214868 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 12
Secondary outcomes (48)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuralgia, PostherpeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678924
- Sponsor's protocol ID
- 214868-007
- Other IDs
- 2012-002240-24
- Status last verified
- Dec 2019
- First submitted
- 31 Aug 2012
- Last updated
- 7 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT01678924
- Acronym / sponsor ID
- 214868-007
- Conditions
- Neuralgia, Postherpetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 280 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Posted 7 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGN-214868 Dose 1 | Experimental | Drug: AGN-214868AGN-214868 Dose 1 given as injections into the area of pain on Day 1. |
| AGN-214868 Dose 2 | Experimental | Drug: AGN-214868AGN-214868 Dose 2 given as injections into the area of pain on Day 1. |
| AGN-214868 Placebo (Vehicle) | Placebo comparator | Drug: AGN-214868 Placebo (Vehicle)AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1. |
| AGN-214868 Dose 3 | Experimental | Drug: AGN-214868AGN-214868 Dose 3 given as injections into the area of pain on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postherpetic neuralgia with pain present for at least 9 months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN-214868AGN-214868 given as injections into the area of pain on Day 1. | Drug | AGN-214868 Dose 1, AGN-214868 Dose 2, AGN-214868 Dose 3 |
| AGN-214868 Placebo (Vehicle)AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1. | Drug | AGN-214868 Placebo (Vehicle) |
Primary outcome
Change From Baseline in Average Pain Intensity Score - Cohort 1
Time frame: 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
Time frame: 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.
48 secondary outcomes
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1
Time frame: Baseline to Week 1
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2
Time frame: Baseline to Week 2
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3
Time frame: Baseline to Week 3
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4
Time frame: Baseline to Week 4
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5
Time frame: Baseline to Week 5
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6
Time frame: Baseline to Week 6
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7
Time frame: Baseline to Week 7
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8
Time frame: Baseline to Week 8
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9
Time frame: Baseline to Week 9
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10
Time frame: Baseline to Week 10
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11
Time frame: Baseline to Week 11
Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12
Time frame: Baseline to Week 12
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1
Time frame: Baseline to Week 1
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2
Time frame: Baseline to Week 2
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3
Time frame: Baseline to Week 3
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4
Time frame: Baseline to Week 4
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5
Time frame: Baseline to Week 5
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6
Time frame: Baseline to Week 6
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7
Time frame: Baseline to Week 7
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8
Time frame: Baseline to Week 8
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9
Time frame: Baseline to Week 9
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10
Time frame: Baseline to Week 10
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11
Time frame: Baseline to Week 11
Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12
Time frame: Baseline to Week 12
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2
Time frame: Baseline to Week 2
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4
Time frame: Baseline to Week 4
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8
Time frame: Baseline to Week 8
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12
Time frame: Baseline to Week 12
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2
Time frame: Baseline to Week 2
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4
Time frame: Baseline to Week 4
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8
Time frame: Baseline to Week 8
Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12
Time frame: Baseline to Week 12
Change From Baseline in Area of Allodynia - Cohort 1 - Week 2
Time frame: Baseline to Week 2
Change From Baseline in Area of Allodynia - Cohort 1 - Week 4
Time frame: Baseline to Week 4
Change From Baseline in Area of Allodynia - Cohort 1 - Week 8
Time frame: Baseline to Week 8
Change From Baseline in Area of Allodynia - Cohort 1 - Week 12
Time frame: Baseline to Week 12
Change From Baseline in Area of Allodynia - Cohort 2 - Week 2
Time frame: Baseline to Week 2
Change From Baseline in Area of Allodynia - Cohort 2 - Week 4
Time frame: Baseline to Week 4
Change From Baseline in Area of Allodynia - Cohort 2 - Week 8
Time frame: Baseline to Week 8
Change From Baseline in Area of Allodynia - Cohort 2 - Week 12
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
69 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGN-214868 in people with Neuralgia, Postherpetic, run by Allergan at 69 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Germany, Poland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Average Pain Intensity Score - Cohort 1 (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.