Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021)

Summary

The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the treatment of painful diabetic neuropathy (PDN) in adults.

Timeline

Start

2012-03-26

Primary completion

2013-04-18

Completion

2013-04-18

Outcome

Missed primary endpoint

paper no significant difference in proportion of patients with efficacy failure during the double-blind period with filorexant versus placebo among primary (24.3% vs. 32.1% [P=0.411]) PMID 28448426 ↗

Publications

• Results Joseph Herring W, Ge JY, Jackson S, Assaid C, Connor KM, Michelson D. Orexin Receptor Antagonism in Painful Diabetic Neuropathy: A Phase 2 Trial With Filorexant. Clin J Pain. 2018 Jan;34(1):37-43. doi: 10.1097/AJP.0000000000000503.

Drugs

Indications