A Study of Modafinil for the Treatment of Fatigue in Patients with Primary Biliary Cirrhosis


About this study

The purpose of this study is to evaluate the safety and effectiveness of modafinil for the treatment of fatigue in patients who have Primary Biliary Cirrhosis.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Primary biliary cirrhosis will be defined as present when 2 of 3 of the following criteria are met
    • Chronic cholestatic liver disease for greater than 6 months with alkaline phosphatase levels greater than 1.5 times the upper limit of normal prior to UDCA treatment
    • Positive AMA titer greater or equal to 1:40 or AMA greater than 0.1U
    • Liver histology in the past with features consistent with or diagnostic of PBC
  • A previous ultrasound, computed tomography (CT), or cholangiography of the biliary tree excludes biliary obstruction
  • Verbal report of fatigue for greater than 6 months

Exclusion Criteria

  • Other serious coexistent conditions such as pre-existing advanced malignancy or severe cardiopulmonary disease which would be expected to limit life expectancy to less than three years
  • Findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis or sclerosing cholangitis
  • Treatment of underlying PBC has been modified in the preceding six months
  • Anticipated need for transplantation in one year (Mayo survival model < 80% one-year survival without transplant) or MELD above 15
  • Recurrent variceal bleeding, presence of diuretic-resistant ascites, or spontaneous encephalopathy
  • Active drug or alcohol use
  • History of drug and/or stimulant (e.g. methylphenidate, amphetamine, or cocaine) abuse
  • Serum bilirubin >4 mg/dl
  • Serum creatinine over 1.4 mg/dl
  • Pregnancy
  • Breast-feeding
  • Inability or unwillingness to practice contraceptive measures for the prevention of pregnancy if appropriate
  • Other fatigue related diagnoses such as anemia, thyroid disease, renal failure, use of beta-blockers and untreated depression
  • Known hypersensitivity to modafinil
  • Uncontrolled hypertension
  • Hypertension and left ventricular hypertrophy documented on ECG in the last 2 years
  • Recent (< 6 months) history of myocardial infarction or unstable angina
  • history of psychosis
  • Receiving cyclosporine, warfarin, tricyclic agents, carbamazepine, phenobarbital, rifampin, ketoconazole or itraconazole in the last 3 months

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Jayant Talwalkar, M.D.

Closed for enrollment

More information


Publications are currently not available

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