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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

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 5, 2012
Results First Submitted Date  ICMJE August 2, 2016
Results First Posted Date  ICMJE January 7, 2020
Last Update Posted Date January 7, 2020
Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
Change from Baseline in Average Pain Intensity Score [ Time Frame: Baseline, Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
  • Percentage of Average Pain Intensity Score Responders [ Time Frame: Week 12 ]
  • Change from Baseline in Maximal Area of Spontaneous Pain [ Time Frame: Baseline, 12 Weeks ]
  • Change from Baseline in Area of Allodynia [ Time Frame: Baseline, 12 Weeks ]
  • Change from Baseline in Evoked Pain Score in the Area of Allodynia [ Time Frame: Baseline, 12 Weeks ]
  • Change from Baseline in Average Pain Intensity Score [ Time Frame: Baseline, 8 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
Official Title  ICMJE Not Provided
Brief Summary This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia, Postherpetic
Intervention  ICMJE
  • Drug: AGN-214868
    AGN-214868 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.
Study Arms  ICMJE
  • Experimental: AGN-214868 Dose 1
    AGN-214868 Dose 1 given as injections into the area of pain on Day 1.
    Intervention: Drug: AGN-214868
  • Experimental: AGN-214868 Dose 2
    AGN-214868 Dose 2 given as injections into the area of pain on Day 1.
    Intervention: Drug: AGN-214868
  • Placebo Comparator: AGN-214868 Placebo (Vehicle)
    AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
    Intervention: Drug: AGN-214868 Placebo (Vehicle)
  • Experimental: AGN-214868 Dose 3
    AGN-214868 Dose 3 given as injections into the area of pain on Day 1.
    Intervention: Drug: AGN-214868
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 19, 2019)
280
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2012)
342
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Poland,   United States
Removed Location Countries Australia,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01678924
Other Study ID Numbers  ICMJE 214868-007
2012-002240-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP