Armodafinil for Patients Starting Hepatitis C Virus Treatment

This study is currently recruiting participants.
Verified March 2014 by Research Foundation for Mental Hygiene, Inc.
Sponsor:
Collaborators:
Mount Sinai School of Medicine
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Judith G. Rabkin, PhD, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT01470651
First received: October 13, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Armodafinil
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Armodafinil for Patients Starting Hepatitis C Treatment

Resource links provided by NLM:


Further study details as provided by Research Foundation for Mental Hygiene, Inc.:

Primary Outcome Measures:
  • Adherence to Medications Form [ Time Frame: HCV medication adherence reported at 12 weeks ] [ Designated as safety issue: No ]
    The Medication Adherence Form was designed to assess any HCV medication dosing changes, including discontinuation, and the reasons for the changes. The form asks specifically about the HCV medications: pegylated interferon, ribavirin and Incivek (or Victrelis), as well as the study medication, armodafinil.


Secondary Outcome Measures:
  • Fatigue Severity Scale (FSS) [ Time Frame: Biweekly for the first month, monthly thereafter ] [ Designated as safety issue: No ]
    Fatigue Severity Scale is a 9-item scale measures the impact of fatigue on everyday functioning (e.g. "fatigue interferes with my work, family or social life"). Response format is a 7-point Likert scale of agreement, with a 1-week time frame. Total score is the sum of item scores. It correlates highly with other measures of fatigue, is sensitive to change, and is routinely used in studies of modafinil/armodafinil.


Estimated Enrollment: 130
Study Start Date: October 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Armodafinil
Active medication
Drug: Armodafinil
50mg - 250mg pills, taken each morning, for 14 weeks
Other Name: Nuvigil
Placebo Comparator: Sugar pill
Inactive pill, matched to look like active medication
Drug: Placebo
Inactive pill, matched to look like active medication

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470651

Contacts
Contact: Judith G. Rabkin, Ph.D., MPH 212.543.5762 jgr1@columbia.edu

Locations
United States, New York
Mount Sinai Medical Center Recruiting
New York City, New York, United States, 10029
Contact: Jeffery Weiss, Ph.D., MS    212-824-7571    Jeffrey.Weiss@mssm.edu   
Contact: Anna Kress    212.824.7571    Anna.kress@mountsinai.org   
New York-Presbyterian/Weill Cornell Medical Center Recruiting
New York City, New York, United States, 10065
Contact: Janna S Gordon-Elliott, M.D.    212-746-3636    jsg2005@med.cornell.edu   
Contact: Ashly Cochran, M.S.    212.746.3754    asc2005@med.cornell.edu   
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Mount Sinai School of Medicine
Weill Medical College of Cornell University
Investigators
Principal Investigator: Jeffrey Weiss, Ph.D., MS Mount Sinai School of Medicine
Principal Investigator: Stephen J. Ferrando, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Judith G. Rabkin, PhD, Research Scientist VI, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01470651     History of Changes
Other Study ID Numbers: C10953/6285
Study First Received: October 13, 2011
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Research Foundation for Mental Hygiene, Inc.:
HCV+
HCV treatment
Fatigue
patients starting alpha interferon/ribavirin treatment

Additional relevant MeSH terms:
Hepatitis, Viral, Human
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 16, 2014