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

NCT ID: NCT00943176

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sugar Pill

Group Type: PLACEBO_COMPARATOR

Modafinil

Intervention Type: DRUG

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.

Modafinil

Group Type: EXPERIMENTAL

Modafinil

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Provigil

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Gastroenterology

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Keith D Lindor, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27148676 (View on PubMed)

Other Identifiers

08-007692

Identifier Type: -

Identifier Source: org_study_id