Armodafinil for Patients Starting Hepatitis C Virus Treatment

NCT ID: NCT01470651

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-06-30

Brief 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.

Detailed Description

Four million Americans have chronic hepatitis C (HCV), and 30% of HIV+ patients are co-infected with HCV. Until May 2011, the standard treatment for HCV was the combination of alpha interferon (injected weekly) and ribavirin (daily pills) (IFN/RBV) for 48 weeks in order to achieve sustained virologic remission (cure). HCV treatment initiation was low, often because of concern about severe treatment side effects as well as high rates of virologic failure. Among the minority of medically eligible HCV+ patients (with or without co-morbid HIV/AIDS) who actually began treatment with IFN/RBV, side effects cause substantial attrition (about 20% by Week 12, 40% by Week 24). The most common adverse events are flu-like symptoms, of which fatigue is most prominent. Depressed mood is also common (mostly somatic symptoms).

Two new medications, telaprevir and boceprevir (protease inhibitors) have been successful in treatment of HCV in clinical trials, and both were approved by the FDA for those patients with genotype 1 HCV, and are marketed as of May 2011. One of the new drugs will be added to the current regimen for genotype 1 infection. Because both drugs are protease inhibitors, which develop rapid resistance when administered alone, they must be added to the current standard of care rather than replace it. This is expected to vastly increase willingness of doctors to recommend treatment, and for patients to agree to treatment. The investigators expect that most hepatologists will recommend, and patients agree to the addition of one of these medications from now on. However, it should be noted that both commonly cause fatigue if it isn't already present because of HCV itself, or peginterferon or ribavirin. The major adverse event associated with telaprevir is rash, and with boceprevir, anemia.

This is a 14-week placebo controlled double blind trial of armodafinil for patients about to begin HCV treatment, starting armodafinil or placebo 2 weeks prior to initiation of HCV treatment. Patients are recruited from the hepatology clinics at the respective sites. Randomization is 1:1. Placebo patients who continue HCV treatment are offered 14 weeks of armodafinil starting at Week 12 of HCV treatment when the armodafinil/placebo blind is broken.

Patients will be seen weekly for the first 4 weeks to titrate armodafinil dose and manage side effects, if any, and then biweekly, with telephone contact on the intervening weeks through Week 12. After that, monthly telephone calls through Week 24 will be conducted with patients randomized to armodafinil, and biweekly visits with placebo patients beginning armodafinil at Week 12.

The primary outcome measures concern non-adherence to INF/RBV treatment: 1) missed doses; 2) dose reductions, and 3) attrition due to side effects. Secondary outcomes include ratings of fatigue on the Fatigue Severity Scale, depression on the Patient Health Questionnaire (PHQ-9), and quality of life on the Endicott Quality of Life Enjoyment and Satisfaction Questionnaire.

Conditions

Hepatitis C

Study Design

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

Study Groups

Armodafinil

Active medication

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

50mg - 250mg pills, taken each morning, for 14 weeks

Sugar pill

Inactive pill, matched to look like active medication

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: DRUG

Inactive pill, matched to look like active medication

Interventions

Armodafinil

50mg - 250mg pills, taken each morning, for 14 weeks

Intervention Type: DRUG

Sugar Pill

Inactive pill, matched to look like active medication

Intervention Type: DRUG

Other Intervention Names

Nuvigil; Placebo Comparator

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Judith G. Rabkin, PhD

Research Scientist VI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Weiss, Ph.D., MS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Stephen J. Ferrando, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Mount Sinai Medical Center

New York, New York, United States

New York-Presbyterian/Weill Cornell Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

C10953/6285

Identifier Type: -

Identifier Source: org_study_id