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

Neuralgia, Postherpetic Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01678924
• Other study ID #: 214868-007
• Secondary ID: 2012-002240-24
• Status: Terminated
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: December 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 280
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic

Intervention

Drug:
• AGN-214868
AGN-214868 given as injections into the area of pain on Day 1.
• AGN-214868 Placebo (Vehicle)
AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.

Locations

Country	Name	City	State
Austria	SMZ-Ost Donauspital	Vienna
Austria	AKH Wien	Wien
Austria	Wilhelminenspital der Stadt Wien	Wien
Germany	Berlin Research Centre	Berlin
Germany	Regionales Schmerzzentrum DGS	Bielefeld
Germany	Bochum Research Centre	Bochum
Germany	Das Schmerzzentrum Celle	Celle
Germany	Ambulant study centre	Cologne
Germany	Leiter des Universitats Schmerz Centrums (USC)	Dresden
Germany	Neuro-Consil GmbH	Düsseldorf
Germany	Frankfurt Research Centre	Frankfurt
Germany	Schmerz und Palliativzentrum Fulda	Fulda
Germany	Schmerz und Palliativ- Zentrum Goeppingen	Goeppingen
Germany	Klinikum Hanau GmbH	Hanau
Germany	Neurologische Praxis Heidenheim	Heidenheim
Germany	Facharzt fur Neurologie	Hoppegarten
Germany	Pro scientia med im MARE Klinikum	Kiel	Schleswig-Holstein
Germany	Schmerzklinik Kiel	Kiel
Germany	Leipzig Research Centre	Leipzig
Germany	Medamed GmbH	Leipzig
Germany	Magdeburg Research Centre	Magdeburg
Germany	Regionales Schmerz- und Palliativ Zentrum DGS Mainz	Mainz
Germany	Universitätsklinik Ulm	Ulm
Germany	Schmerztherapiezentrum Villingen-Schwenningen	Villingen-Schwenningen
Poland	Medica Pro Familia Sp. Z.o.o SKA	Gdynia
Poland	Medica Pro Familia Sp. Z.o.o SKA	Katowice
Poland	Malopolskie Centrum Medyczne S.C.	Krakow
Poland	Specjalistyczny Gabinet Neurologiczny	Krakow
Poland	Nzoz Neuromed	Lublin
Poland	NZOZ Neuro-Kard	Poznan
Poland	Poznanski Osrodek Medyczny NOVAMED	Poznan	Poznañ
Poland	Niepubliczny Zaklad Opieki Zdrowotnej	Swidnik
Poland	Osrodek Badan Klinicznych Euromedis Sp. z o.o.	Szczecin
Poland	Medica Pro Familia Warszawa	Warszawa
Poland	Przychodnia Specjalistyczna PROSEN	Warszawa
Poland	Synexus SCM sp. z o.o.	Wroclaw
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	Allegheny Pain Management	Altoona	Pennsylvania
United States	Michigan Head Pain and Neurology Institute	Ann Arbor	Michigan
United States	Millennium Pain Center	Bloomington	Illinois
United States	Injury Care Research, LLC	Boise	Idaho
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Beacon Clinical Research	Brockton	Massachusetts
United States	Clinical Trials of South Carolina, LLC	Charleston	South Carolina
United States	PharmaCorp Clinical Trials, Inc	Charleston	South Carolina
United States	The Mile High Research Center	Denver	Colorado
United States	Riverside Clinical Research	Edgewater	Florida
United States	Plains Medical Clinic	Fargo	North Dakota
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Neuro-Pain Medical Center	Fresno	California
United States	University of California, Irvine	Irvine	California
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Loma Linda University	Loma Linda	California
United States	Drug Studies America	Marietta	Georgia
United States	Agave Clinical Research, LLC	Mesa	Arizona
United States	Clinical Research of Charleston	Mount Pleasant	South Carolina
United States	The Medical Research Network, LLC	New York	New York
United States	COR Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Compass Research, LLC	Orlando	Florida
United States	Island Neurological Associates, P.C.	Plainview	New York
United States	Wake Research Associates	Raleigh	North Carolina
United States	Northern California Research Corp	Sacramento	California
United States	Neurological Research Institute	Santa Monica	California
United States	Clinvest Headache Care Center	Springfield	Missouri
United States	Springfield Neurology Associates, LLC	Springfield	Massachusetts
United States	MultiCare Neuroscience Center of Washington	Tacoma	Washington
United States	Territory Neurology & Research Institute	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	Center for Clinical Studies	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Average Pain Intensity Score - Cohort 1	The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.	Baseline to Week 12
Primary	Change From Baseline in Average Pain Intensity Score - Cohort 2	The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment.	Baseline to Week 12
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 1
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 2
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 3
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline	Baseline to Week 4
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 5
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 6
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 7
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 8
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 9
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 10
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 11
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 12
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 1
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 2
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 3
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 4
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 5
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 6
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 7
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 8
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 9
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 10
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 11
Secondary	Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12	Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline	Baseline to Week 12
Secondary	Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient and that the patient was asked to circle their MASP on with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 2
Secondary	Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 4
Secondary	Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 8
Secondary	Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 12
Secondary	Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 2
Secondary	Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 4
Secondary	Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 8
Secondary	Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12	The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.	Baseline to Week 12
Secondary	Change From Baseline in Area of Allodynia - Cohort 1 - Week 2	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 2
Secondary	Change From Baseline in Area of Allodynia - Cohort 1 - Week 4	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 4
Secondary	Change From Baseline in Area of Allodynia - Cohort 1 - Week 8	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 8
Secondary	Change From Baseline in Area of Allodynia - Cohort 1 - Week 12	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 12
Secondary	Change From Baseline in Area of Allodynia - Cohort 2 - Week 2	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 2
Secondary	Change From Baseline in Area of Allodynia - Cohort 2 - Week 4	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 4
Secondary	Change From Baseline in Area of Allodynia - Cohort 2 - Week 8	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 8
Secondary	Change From Baseline in Area of Allodynia - Cohort 2 - Week 12	The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.	Baseline to Week 12
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 2
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 4
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 8
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 12
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 2
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 4
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 8
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12	Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.	Baseline to Week 12