Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)

Phase 1 Completed 40 enrolled Mayo Clinic American College of Gastroenterology · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the use of modafinil in the treatment of fatigue in patients with Primary Biliary Cirrhosis. The general aim of the study is to identify a safe and effective therapy for fatigue in patients with primary biliary cirrhosis.

Timeline

Start: 2009-06
Primary completion: 2011-04
Completion: 2011-04

Outcome

Missed primary endpoint

paper 3 patients (17.6%) in the modafinil arm and 2 (12.5%) in the placebo arm (P = 1.00). PMID 27148676 ↗

paper however, it did not result in beneficial effects on fatigue compared with patients treated with placebo PMID 27148676 ↗

Publications

Silveira MG, Gossard AA, Stahler AC, Jorgensen RA, Petz JL, Ali AH, Lindor KD. A Randomized, Placebo-Controlled Clinical Trial of Efficacy and Safety: Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis. Am J Ther. 2017 Mar/Apr;24(2):e167-e176. doi: 10.1097/MJT.0000000000000387.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Modafinil	Small molecule	100 mg	Oral