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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01678924
Date of registration:	31/08/2012
Prospective Registration:	Yes
Primary sponsor:	Allergan
Public title:	A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
Scientific title:
Date of first enrolment:	January 2013
Target sample size:	280
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT01678924
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase:	Phase 2

Countries of recruitment
Australia	Austria	Czech Republic	Germany	Poland	United States

Contacts

Name:	Medical Director
Address:
Telephone:
Email:
Affiliation:	Allergan

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neuralgia, Postherpetic

Intervention(s)

Drug: AGN-214868 Placebo (Vehicle)

Drug: AGN-214868

Primary Outcome(s)

Change From Baseline in Average Pain Intensity Score - Cohort 1 [Time Frame: Baseline to Week 12]

Change From Baseline in Average Pain Intensity Score - Cohort 2 [Time Frame: Baseline to Week 12]

Secondary Outcome(s)

Change From Baseline in Evoked Pain Score in the Area of Allodynia 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 2 - Week 12 [Time Frame: Baseline to Week 12]

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 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]

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

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 8 [Time Frame: Baseline to Week 8]

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

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

Change From Baseline in Area of Allodynia - Cohort 2 - 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 Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12 [Time Frame: Baseline to Week 12]

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

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 2 - Week 10 [Time Frame: Baseline to Week 10]

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 4 [Time Frame: Baseline to Week 4]

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 5 [Time Frame: Baseline to Week 5]

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

Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12 [Time Frame: Baseline to Week 12]

Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7 [Time Frame: Baseline to Week 7]

Change From Baseline in Evoked Pain Score in the Area of Allodynia 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]

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

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

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

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

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

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 9 [Time Frame: Baseline to Week 9]

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 2 - Week 2 [Time Frame: Baseline to Week 2]

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

Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3 [Time Frame: Baseline to Week 3]

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

Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4 [Time Frame: Baseline to Week 4]

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]

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 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 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]

Secondary ID(s)

214868-007

2012-002240-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	07/01/2020
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01678924

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