Phase 2 N=294 Randomized Double-blind Treatment

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

Neuralgia, Postherpetic

Bottom Line

View on ClinicalTrials.gov: NCT01129531 ↗

Enrolled (actual)

294

Serious AEs

3.0%

Results posted

Nov 2013

Primary outcome: Primary: Change From Baseline in the Average Pain Intensity Score at Week 12 — 6.13; 6.04; 6.05; -1.42 Score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AGN-214868 (Drug); Placebo to AGN-214868 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Average Pain Intensity Score at Week 12	6.13; 6.04; 6.05; -1.42; -1.35; -1.27	—
SECONDARY Change From Baseline in Area of Spontaneous Pain	87.44; 118.17; 98.27; -4.83; -17.18; -6.13	—
SECONDARY Change From Baseline in Area of Allodynia	184.28; 195.11; 174.17; -32.40; -43.56; -15.27	—
SECONDARY Change From Baseline in Evoked Pain Score in the Area of Allodynia	60.8; 58.4; 60.0; -11.7; -7.9; -11.1	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01129531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.