Armodafinil for Patients Starting Hepatitis C Virus Treatment
Status:
Terminated
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Research Foundation for Mental Hygiene, Inc.
Collaborators:
Icahn School of Medicine at Mount Sinai Weill Medical College of Cornell University