Armodafinil for Patients Starting Hepatitis C Virus Treatment

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Fatigue is one of the most common side effects of the treatment of hepatitis C infection with pegylated interferon and ribavirin, and is a major cause of treatment discontinuation. Armodafinil is an FDA approved stimulant medication for the treatment of narcolepsy and shift-work sleep disorder. This is a randomized placebo controlled study to determine whether patients assigned to armodafinil have fewer missed doses, dose reductions or treatment discontinuation due to side effects in the first 12 weeks of treatment for hepatitis C infection than do placebo patients. Placebo patients are offered 14 weeks of open label armodafinil after Week 12.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research Foundation for Mental Hygiene, Inc.
• Collaborators: Icahn School of Medicine at Mount Sinai; Weill Medical College of Cornell University
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• HCV+ patients medically cleared for IFN/RBV treatment -HIV+ or HIV-

• Speaks English

• Able and willing to give informed consent

• Fecund women: use barrier method of contraception

Exclusion Criteria:

• Untreated and uncontrolled hypertension

• Left ventricular hypertrophy

• Currently taking stimulant medication

• Uncontrolled mental health problems including: MDD, suicidal or homicidal ideation, bipolar disorder, or schizophrenia