Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

NCT01271933 ↗

Phase 3 Completed 441 enrolled Viatris Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.

Timeline

Start: 2011-03
Primary completion: 2012-07
Completion: 2012-07

Outcome

Met primary endpoint

paper The median time to LTR (Kaplan-Meier analysis) was significantly longer in the pregabalin CR group than placebo (58 vs. 22 days, p = 0.02). PMID 24867298 ↗

registry Pregabalin (Double Blind Phase) vs Placebo (Double Blind Phase); p = 0.0186; Log Rank NCT01271933 ↗

Publications

Arnold LM, Arsenault P, Huffman C, Patrick JL, Messig M, Chew ML, Sanin L, Scavone JM, Pauer L, Clair AG. Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. Curr Med Res Opin. 2014 Oct;30(10):2069-83. doi: 10.1185/03007995.2014.928275. Epub 2014 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	330 mg	—
Subject	Pregabalin	Small molecule	495 mg	—