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A phase 2a, randomized, crossover trial of gabapentin enacarbil for the treatment of postherpetic neuralgia in gabapentin inadequate responders.
Pain Med. 2013 Dec; 14(12):1918-32.PM

Abstract

OBJECTIVE

To compare the efficacy of high-dose (3,600 mg/day) vs low-dose (1,200 mg/day) oral gabapentin enacarbil (GEn) on pain intensity in adults with postherpetic neuralgia (PHN) and a history of inadequate response to ≥1,800 mg/day gabapentin.

DESIGN

Multicenter, randomized, double-blind, crossover study (NCT00617461).

SETTING

Thirty-five outpatient centers in Germany and the United States.

SUBJECTS

Subjects aged ≥18 years with a diagnosis of PHN.

METHODS

During a 2-week baseline period, subjects received open-label treatment with 1,800 mg/day gabapentin. Subjects who had a mean 24-hour average pain intensity score ≥4 during the last 7 days of the baseline period were randomized to receive GEn (1,200 or 3,600 mg/day) for treatment period 1 (28 days), followed by GEn 2,400 mg/day (4 days), and the alternate GEn dose for treatment period 2 (28 days).

RESULTS

There was a modest but significant improvement in pain intensity scores with GEn 3,600 mg vs 1,200 mg (adjusted mean [90% confidence interval] treatment difference, -0.29 [-0.48 to -0.10]; P = 0.013). The difference in efficacy between doses was observed primarily in subjects who received the higher dose during treatment period 2; certain aspects of the study design may have contributed to this outcome. Plasma steady-state gabapentin exposure during GEn treatment was as expected and consistent between treatment periods. No new safety signals or adverse event trends relating to GEn exposure were identified.

CONCLUSIONS

While the overall results demonstrated efficacy in a PHN population, the differences between treatment periods confound the interpretation. These findings could provide insight into future trial designs.

Authors+Show Affiliations

Rehabilitation Institute of Chicago, Chicago, Illinois, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24102928

Citation

Harden, R Norman, et al. "A Phase 2a, Randomized, Crossover Trial of Gabapentin Enacarbil for the Treatment of Postherpetic Neuralgia in Gabapentin Inadequate Responders." Pain Medicine (Malden, Mass.), vol. 14, no. 12, 2013, pp. 1918-32.
Harden RN, Freeman R, Rainka M, et al. A phase 2a, randomized, crossover trial of gabapentin enacarbil for the treatment of postherpetic neuralgia in gabapentin inadequate responders. Pain Med. 2013;14(12):1918-32.
Harden, R. N., Freeman, R., Rainka, M., Zhang, L., Bell, C., Berges, A., Chen, C., Graff, O., Harding, K., Hunter, S., Kavanagh, S., Schwartzbach, C., Warren, S., & McClung, C. (2013). A phase 2a, randomized, crossover trial of gabapentin enacarbil for the treatment of postherpetic neuralgia in gabapentin inadequate responders. Pain Medicine (Malden, Mass.), 14(12), 1918-32. https://doi.org/10.1111/pme.12227
Harden RN, et al. A Phase 2a, Randomized, Crossover Trial of Gabapentin Enacarbil for the Treatment of Postherpetic Neuralgia in Gabapentin Inadequate Responders. Pain Med. 2013;14(12):1918-32. PubMed PMID: 24102928.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase 2a, randomized, crossover trial of gabapentin enacarbil for the treatment of postherpetic neuralgia in gabapentin inadequate responders. AU - Harden,R Norman, AU - Freeman,Roy, AU - Rainka,Michelle, AU - Zhang,Lixin, AU - Bell,Chris, AU - Berges,Alienor, AU - Chen,Chao, AU - Graff,Ole, AU - Harding,Kathleen, AU - Hunter,Setrina, AU - Kavanagh,Sarah, AU - Schwartzbach,Caryl, AU - Warren,Samantha, AU - McClung,Carrie, Y1 - 2013/09/18/ PY - 2013/10/10/entrez PY - 2013/10/10/pubmed PY - 2014/8/19/medline KW - Gabapentin Enacarbil KW - Inadequate Responders KW - PHN KW - Postherpetic Neuralgia SP - 1918 EP - 32 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 14 IS - 12 N2 - OBJECTIVE: To compare the efficacy of high-dose (3,600 mg/day) vs low-dose (1,200 mg/day) oral gabapentin enacarbil (GEn) on pain intensity in adults with postherpetic neuralgia (PHN) and a history of inadequate response to ≥1,800 mg/day gabapentin. DESIGN: Multicenter, randomized, double-blind, crossover study (NCT00617461). SETTING: Thirty-five outpatient centers in Germany and the United States. SUBJECTS: Subjects aged ≥18 years with a diagnosis of PHN. METHODS: During a 2-week baseline period, subjects received open-label treatment with 1,800 mg/day gabapentin. Subjects who had a mean 24-hour average pain intensity score ≥4 during the last 7 days of the baseline period were randomized to receive GEn (1,200 or 3,600 mg/day) for treatment period 1 (28 days), followed by GEn 2,400 mg/day (4 days), and the alternate GEn dose for treatment period 2 (28 days). RESULTS: There was a modest but significant improvement in pain intensity scores with GEn 3,600 mg vs 1,200 mg (adjusted mean [90% confidence interval] treatment difference, -0.29 [-0.48 to -0.10]; P = 0.013). The difference in efficacy between doses was observed primarily in subjects who received the higher dose during treatment period 2; certain aspects of the study design may have contributed to this outcome. Plasma steady-state gabapentin exposure during GEn treatment was as expected and consistent between treatment periods. No new safety signals or adverse event trends relating to GEn exposure were identified. CONCLUSIONS: While the overall results demonstrated efficacy in a PHN population, the differences between treatment periods confound the interpretation. These findings could provide insight into future trial designs. SN - 1526-4637 UR - https://www.unboundmedicine.com/medline/citation/24102928/A_phase_2a_randomized_crossover_trial_of_gabapentin_enacarbil_for_the_treatment_of_postherpetic_neuralgia_in_gabapentin_inadequate_responders_ L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/pme.12227 DB - PRIME DP - Unbound Medicine ER -