Armodafinil for Patients Starting Hepatitis C Virus Treatment

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01470651

Run by

Research Foundation for Mental Hygiene, Inc.

People needed

26

Starts

2011-10-01

Expected to finish

2014-06-01

Last updated by the study team

2017-02-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Sinai Medical Center — New York, New York, United States
• New York-Presbyterian/Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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