NCT00943176

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

Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The general aim of the study is to identify a safe and effective therapy for fatigue in patients with primary biliary cirrhosis. Specific aims include: 1) to determine the safety profile of modafinil in patients with primary biliary cirrhosis; 2) to evaluate the beneficial effects of modafinil on patients with primary biliary cirrhosis and fatigue as documented by a well-validated questionnaire (Fisk Fatigue Severity Score) to be applied at the beginning and end of the study period; and 3) to compare the performance of three questionnaires (Fisk Fatigue Severity Score, Fatigue Severity Scale and the fatigue domain of the PBC-40) as instruments to determine the benefits of a therapeutic intervention on fatigue by establishing the minimally important clinical difference of these measures of fatigue.

Conditions

• Fatigue
• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Modafinil	100 mg tablets of modafinil or matched placebo will be given for a total of 12 weeks. Patients will be instructed to start one capsule once daily (modafinil or placebo), and dose will be titrated according to tolerability and response.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-07-22
• Last updated: 2012-01-18

Locations

1 site across 1 country: United States