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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01678924
Recruitment Status : Terminated
First Posted : September 5, 2012
Results First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Neuralgia, Postherpetic Drug: AGN-214868 Drug: AGN-214868 Placebo (Vehicle) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: AGN-214868 Dose 1
AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
Drug: AGN-214868
AGN-214868 given as injections into the area of pain on Day 1.

Experimental: AGN-214868 Dose 2
AGN-214868 Dose 2 given as injections into the area of pain on Day 1.
Drug: AGN-214868
AGN-214868 given as injections into the area of pain on Day 1.

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

Experimental: AGN-214868 Dose 3
AGN-214868 Dose 3 given as injections into the area of pain on Day 1.
Drug: AGN-214868
AGN-214868 given as injections into the area of pain on Day 1.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 [ Time Frame: 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

  2. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2 [ Time Frame: 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

  3. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3 [ Time Frame: 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

  4. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4 [ Time Frame: 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

  5. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5 [ Time Frame: 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

  6. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6 [ Time Frame: 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

  7. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7 [ Time Frame: 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

  8. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8 [ Time Frame: 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

  9. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9 [ Time Frame: 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

  10. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10 [ Time Frame: 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

  11. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11 [ Time Frame: 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

  12. Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12 [ Time Frame: 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

  13. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1 [ Time Frame: 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

  14. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2 [ Time Frame: 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

  15. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3 [ Time Frame: 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

  16. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4 [ Time Frame: 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

  17. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5 [ Time Frame: 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

  18. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6 [ Time Frame: 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

  19. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7 [ Time Frame: 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

  20. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8 [ Time Frame: 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

  21. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9 [ Time Frame: 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

  22. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10 [ Time Frame: 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

  23. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11 [ Time Frame: 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

  24. Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12 [ Time Frame: 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

  25. Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2 [ Time Frame: 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.

  26. Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4 [ Time Frame: 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.

  27. Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8 [ Time Frame: 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.

  28. Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12 [ Time Frame: 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.

  29. Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2 [ Time Frame: 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.

  30. Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4 [ Time Frame: 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.

  31. Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8 [ Time Frame: 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.

  32. Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12 [ Time Frame: 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.

  33. Change From Baseline in Area of Allodynia - Cohort 1 - Week 2 [ Time Frame: 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.

  34. Change From Baseline in Area of Allodynia - Cohort 1 - Week 4 [ Time Frame: 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.

  35. Change From Baseline in Area of Allodynia - Cohort 1 - Week 8 [ Time Frame: 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.

  36. Change From Baseline in Area of Allodynia - Cohort 1 - Week 12 [ Time Frame: 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.

  37. Change From Baseline in Area of Allodynia - Cohort 2 - Week 2 [ Time Frame: 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.

  38. Change From Baseline in Area of Allodynia - Cohort 2 - Week 4 [ Time Frame: 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.

  39. Change From Baseline in Area of Allodynia - Cohort 2 - Week 8 [ Time Frame: 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.

  40. Change From Baseline in Area of Allodynia - Cohort 2 - Week 12 [ Time Frame: 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.

  41. Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2 [ Time Frame: 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.

  42. Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4 [ Time Frame: 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.

  43. Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8 [ Time Frame: 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.

  44. Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12 [ Time Frame: 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.

  45. Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2 [ Time Frame: 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.

  46. Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4 [ Time Frame: 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.

  47. Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8 [ Time Frame: 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.

  48. Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postherpetic neuralgia with pain present for at least 9 months

Exclusion Criteria:

  • Active herpes zoster skin rash
  • Anticipated treatment for postherpetic neuralgia during the first 3 months of the study, including oral and topical medications, acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS), or trigger point injection
  • Anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the first 3 months of the study
  • Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use during the first 3 months of the study
  • Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678924


Locations
Show Show 69 study locations
Sponsors and Collaborators
Allergan
Investigators
Layout table for investigator information
Study Director: Medical Director Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01678924    
Other Study ID Numbers: 214868-007
2012-002240-24 ( EudraCT Number )
First Posted: September 5, 2012    Key Record Dates
Results First Posted: January 7, 2020
Last Update Posted: January 7, 2020
Last Verified: December 2019
Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms