Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fatigue; Primary Biliary Cirrhosis
Intervention: Modafinil (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Keith D Lindor, M.D., Principal Investigator, Affiliation: Mayo Clinic
Overall contact:
Jan L Petz, RN, Phone: 507-284-3565, Email: jpetz@mayo.edu
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.
Clinical Details
Official title: Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The main endpoint will be the change in fatigue severity (quantified by the FFSS) following 12 weeks of treatment, compared to baseline values.
Secondary outcome: Secondary outcome includes frequency of adverse events, change in alkaline phosphatase, AST, total bilirubin and albumin levels after 12 weeks of therapy compared to baseline values, change in fatigue severity compared to baseline.
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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:
- Patients with other serious coexistent conditions such as pre-existing advanced
malignancy or severe cardiopulmonary disease which would be expected to limit their
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.
- Patients with hypertension and left ventricular hypertrophy documented on ECG in the
last 2 years.
- Recent (<6 months) history of myocardial infarction or unstable angina.
- Patients with history of psychosis.
- Patients receiving cyclosporine, warfarin, tricyclic agents, carbamazepine,
phenobarbital, rifampin, ketoconazole or itraconazole in the last 3 months.
Locations and Contacts
Jan L Petz, RN, Phone: 507-284-3565, Email: jpetz@mayo.edu
Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Jan L Petz, RN, Phone: 507-284-3565, Email: jpetz@mayo.edu
Keith D Lindor, M.D., Principal Investigator
Additional Information
Starting date: June 2009
Ending date: September 2010
Last updated: July 29, 2009
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