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

Neuralgia, Postherpetic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129531
• Other study ID #: 214868-002
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2010
• Last updated: September 12, 2013
• Start date: June 2010
• Est. completion date: January 2012

Study information

• Verified date: September 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash

Exclusion Criteria:

• Female patients with reproductive potential

• Active herpes zoster skin rash

• Current or anticipated treatment with acupuncture, TNS, or steroids

• Current or anticipated use of topical analgesic agents with PHN

• Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic

Intervention

Drug:
• AGN-214868
AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.
• Placebo to AGN-214868
Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Czech Republic,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Average Pain Intensity Score at Week 12	Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.	Baseline, Week 12	No
Secondary	Change From Baseline in Area of Spontaneous Pain	A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.	Baseline, Week 12	No
Secondary	Change From Baseline in Area of Allodynia	A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.	Baseline, Week 12	No
Secondary	Change From Baseline in Evoked Pain Score in the Area of Allodynia	Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.	Baseline, Week 12	No