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Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, an 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia.
BMC Neurol. 2010 Oct 11; 10:92.BN

Abstract

BACKGROUND

Postherpetic neuralgia (PHN) is a painful and difficult to treat complication of acute herpes zoster. Current treatment options provide only partial relief and are often limited by poor tolerability. We evaluated the safety and efficacy of a single 60-minute application of NGX-4010, an 8% capsaicin patch, in patients with PHN.

METHODS

This multicenter, double-blind, controlled study randomized 155 patients 2:1 to receive either NGX-4010 or a 0.04% capsaicin control patch. Patients were at least 18 years old with PHN for at least 3 months, and an average Numeric Pain Rating Scale (NPRS) score of 3 to 9. The primary efficacy endpoint was the percentage change in NPRS score from baseline to weeks 2-8.

RESULTS

The mean percent reduction in "average pain for the past 24 hours" NPRS scores from baseline to weeks 2-8 was greater in the NGX-4010 group (36.5%) compared with control (29.9%) although the difference was not significant (p = 0.296). PGIC analysis demonstrated that more NGX-4010 recipients considered themselves improved (much, or very much) compared with control at weeks 8 and 12, but the differences did not reach statistical significance. Post hoc analyses of patients with PHN for at least 6 months showed significantly greater reductions in "average pain for the past 24 hours" NPRS scores from baseline to weeks 2-8 in NGX-4010 patients compared to controls (37.6% versus 23.4%; p = 0.0291). PGIC analysis in this subgroup demonstrated that significantly more NGX-4010 recipients considered themselves much or very much improved compared with control at week 12 (40% versus 20%; p = 0.0403;).

CONCLUSIONS

Although treatment appeared to be safe and well tolerated, a single 60-minute application of NGX-4010 failed to show efficacy in this study which included patients with PHN for less than 6 months. Large reductions in pain observed among control patients with pain for less than 6 months may have been due to spontaneous resolution of PHN, may have confounded the results of the prespecified analyses, and should be taken into account when designing PHN studies.

TRIAL REGISTRATION

NCT00068081.

Authors+Show Affiliations

Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

20937130

Citation

Webster, Lynn R., et al. "Effect of Duration of Postherpetic Neuralgia On Efficacy Analyses in a Multicenter, Randomized, Controlled Study of NGX-4010, an 8% Capsaicin Patch Evaluated for the Treatment of Postherpetic Neuralgia." BMC Neurology, vol. 10, 2010, p. 92.
Webster LR, Tark M, Rauck R, et al. Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, an 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia. BMC Neurol. 2010;10:92.
Webster, L. R., Tark, M., Rauck, R., Tobias, J. K., & Vanhove, G. F. (2010). Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, an 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia. BMC Neurology, 10, 92. https://doi.org/10.1186/1471-2377-10-92
Webster LR, et al. Effect of Duration of Postherpetic Neuralgia On Efficacy Analyses in a Multicenter, Randomized, Controlled Study of NGX-4010, an 8% Capsaicin Patch Evaluated for the Treatment of Postherpetic Neuralgia. BMC Neurol. 2010 Oct 11;10:92. PubMed PMID: 20937130.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, an 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia. AU - Webster,Lynn R, AU - Tark,Marvin, AU - Rauck,Richard, AU - Tobias,Jeffrey K, AU - Vanhove,Geertrui F, Y1 - 2010/10/11/ PY - 2010/04/22/received PY - 2010/10/11/accepted PY - 2010/10/13/entrez PY - 2010/10/13/pubmed PY - 2011/1/7/medline SP - 92 EP - 92 JF - BMC neurology JO - BMC Neurol VL - 10 N2 - BACKGROUND: Postherpetic neuralgia (PHN) is a painful and difficult to treat complication of acute herpes zoster. Current treatment options provide only partial relief and are often limited by poor tolerability. We evaluated the safety and efficacy of a single 60-minute application of NGX-4010, an 8% capsaicin patch, in patients with PHN. METHODS: This multicenter, double-blind, controlled study randomized 155 patients 2:1 to receive either NGX-4010 or a 0.04% capsaicin control patch. Patients were at least 18 years old with PHN for at least 3 months, and an average Numeric Pain Rating Scale (NPRS) score of 3 to 9. The primary efficacy endpoint was the percentage change in NPRS score from baseline to weeks 2-8. RESULTS: The mean percent reduction in "average pain for the past 24 hours" NPRS scores from baseline to weeks 2-8 was greater in the NGX-4010 group (36.5%) compared with control (29.9%) although the difference was not significant (p = 0.296). PGIC analysis demonstrated that more NGX-4010 recipients considered themselves improved (much, or very much) compared with control at weeks 8 and 12, but the differences did not reach statistical significance. Post hoc analyses of patients with PHN for at least 6 months showed significantly greater reductions in "average pain for the past 24 hours" NPRS scores from baseline to weeks 2-8 in NGX-4010 patients compared to controls (37.6% versus 23.4%; p = 0.0291). PGIC analysis in this subgroup demonstrated that significantly more NGX-4010 recipients considered themselves much or very much improved compared with control at week 12 (40% versus 20%; p = 0.0403;). CONCLUSIONS: Although treatment appeared to be safe and well tolerated, a single 60-minute application of NGX-4010 failed to show efficacy in this study which included patients with PHN for less than 6 months. Large reductions in pain observed among control patients with pain for less than 6 months may have been due to spontaneous resolution of PHN, may have confounded the results of the prespecified analyses, and should be taken into account when designing PHN studies. TRIAL REGISTRATION: NCT00068081. SN - 1471-2377 UR - https://www.unboundmedicine.com/medline/citation/20937130/Effect_of_duration_of_postherpetic_neuralgia_on_efficacy_analyses_in_a_multicenter_randomized_controlled_study_of_NGX_4010_an_8_capsaicin_patch_evaluated_for_the_treatment_of_postherpetic_neuralgia_ L2 - https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-10-92 DB - PRIME DP - Unbound Medicine ER -