Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

Summary

Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.

Timeline

Start

2010-03-31

Primary completion

2012-01-30

Completion

2012-01-30

Outcome

Missed primary endpoint

paper Although the primary endpoint was not met, pregabalin was associated with clinically relevant improvements versus placebo in this difficult-to-treat population. PMID 23887339 ↗

paper there was no significant difference in the primary endpoint of mean pain score (LOCF) between pregabalin and placebo PMID 23887339 ↗

Publications

• Raskin P, Huffman C, Toth C, Asmus MJ, Messig M, Sanchez RJ, Pauer L. Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. Clin J Pain. 2014 May;30(5):379-90. doi: 10.1097/AJP.0b013e31829ea1a1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	150 mg	—
Subject	Pregabalin	Small molecule	300 mg	—

Indications