Fulranumab for treatment of diabetic peripheral neuropathic pain: A randomized controlled trial.

ABSTRACT:

Objective

To assess efficacy and safety of fulranumab, a fully human monoclonal antibody against nerve growth factor, in patients with diabetic peripheral neuropathic pain (DPNP).

Methods

In this phase II, double-blind, placebo-controlled trial, patients with moderate to severe DPNP were randomized to treatments with fulranumab (1, 3, or 10 mg) or placebo administered subcutaneously every 4 weeks.

Results

Because of early study termination (clinical hold) by the US Food and Drug Administration, 77 (intent-to-treat) of the planned 200 patients were enrolled. The primary endpoint, the mean reduction of average daily pain at week 12 compared with baseline, showed a positive dose-response relationship (p = 0.014, 1-sided); the pair-wise comparison between the 10-mg group

SUBMITTER: Wang H 

PROVIDER: S-EPMC4141990 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature