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

NCT00943176 | Completed Phase 1

• 1 other identifier: 08-007692
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Primary Biliary Cirrhosis

Keywords

Fatigue

Outcome Measures

Primary Outcomes (1)

• The main endpoint will be the change in fatigue severity (quantified by the FFSS) following 12 weeks of treatment, compared to baseline values.

  after 12 weeks of treatment

Secondary Outcomes (1)

• 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.

  after 12 weeks of treatment

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Drug: Modafinil

Modafinil

EXPERIMENTAL

Drug: Modafinil

Interventions

Modafinil 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.

Also known as: Provigil

Modafinil; Sugar Pill

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• American College of Gastroenterology: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 27148676 DERIVED

MeSH Terms

Conditions

Fatigue; Liver Cirrhosis, Biliary

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Keith D Lindor, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 22, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

US (1)