IRB Number:

08-007692

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

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.

We hope to develop a strategy for patients with fatigue to improve health related quality of life.

Who is Eligible to Participate in the Study?

Patients with Primary Biliary Cirrhosis who report fatigue for greater than 6 months.

Minimum Age:

21

Maximum Age:

75

What is Involved With this Study?

Should you decide to participate you will be put in one or two groups by chance (as in the flip of a coin). One group will receive modafinil (active medication) and one group will receive placebo (no active medication or "sugar pills"). Neither you, the study doctor, or other study personnel will know which group you are in. You will take the pills for 12 weeks. You will receive phone calls while you are in the study, asking how you are doing. Blood draws will be done twice during the study: at the time you join the study and when the study comes to an end (12 weeks later), you will be asked to complete 3 questionnaires with questions related to your symptoms and quality of life at the time you join the study and then again when the study is complete.

How long will the Study run?

12 weeks

Who can I Contact for Additional Information on this Trial?

Please contact Jan Petz at (507) 284-3565 or Jill Keach at (507) 538-0678.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 07/10/2009