Journal article
A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain
Pain (Amsterdam), Vol.156(10), pp.2013-2020
10/2015
DOI: 10.1097/j.pain.0000000000000263
PMCID: PMC4770341
PMID: 26067585
Abstract
Supplemental Digital Content is Available in the Text.
Treatment with ABT-639 100 mg for 6 weeks did not significantly reduce pain in patients with diabetic peripheral neuropathy.
T-type Ca
v
3.2 calcium channels represent a novel target for neuropathic pain modulation. Preclinical studies with ABT-639, a peripherally acting highly selective T-type Ca
v
3.2 calcium channel blocker, showed dose-dependent reduction of pain in multiple pain models. ABT-639 also demonstrated an acceptable safety profile at single- and multiple-dose levels evaluated in a clinical phase 1 study in healthy volunteers. The primary objective of this phase 2, multicenter, randomized, double-blind, placebo-controlled, and active-controlled study was to compare the analgesic efficacy and safety of ABT-639 with placebo in the treatment of diabetic neuropathic pain. Pregabalin, an approved treatment for painful diabetic neuropathy, was included as a positive control. A total of 194 patients were randomized and treated for 6 weeks; 62 patients received ABT-639 (100 mg twice daily), 70 patients received pregabalin (150 mg twice daily), and 62 patients received placebo. When assessing the mean changes from baseline in patient-recorded pain scores at the end of week 6, there was no significant difference observed for ABT-639 compared with placebo (−2.28 vs −2.36;
P
= 0.582). Pregabalin treatment resulted in a transient improvement in pain compared with placebo, which did not persist throughout the study. There were no significant safety issues identified with ABT-639. A majority of adverse events were considered mild to moderate in intensity. In conclusion, treatment with the highly selective T-type Ca
v
3.2 calcium channel blocker ABT-639 100 mg twice daily for 6 weeks showed no safety signals that would preclude further investigation but did not reduce neuropathic pain in patients with diabetes (
ClinicalTrials.gov
identifier: NCT01345045).
Details
- Title: Subtitle
- A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain
- Creators
- Dan Ziegler - Institute for Clinical Diabetology, German Diabetes Center at Heinrich Heine University; Leibniz Center for Diabetes Research; Department of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Düsseldorf, GermanyW. Rachel Duan - AbbVie Inc, North Chicago, IL, USAGuohua An - AbbVie Inc, North Chicago, IL, USAJames W Thomas - AbbVie Inc, North Chicago, IL, USAWolfram Nothaft - AbbVie Inc, North Chicago, IL, USA
- Resource Type
- Journal article
- Publication Details
- Pain (Amsterdam), Vol.156(10), pp.2013-2020
- DOI
- 10.1097/j.pain.0000000000000263
- PMID
- 26067585
- PMCID
- PMC4770341
- NLM abbreviation
- Pain
- ISSN
- 0304-3959
- eISSN
- 1872-6623
- Publisher
- Wolters Kluwer; Philadelphia, PA
- Language
- English
- Date published
- 10/2015
- Academic Unit
- Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984065691602771
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