NCT01470651

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2011

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

October 13, 2011

Results QC Date

October 25, 2016

Last Update Submit

December 19, 2016

Conditions

Hepatitis C

Keywords

HCV+HCV treatmentFatiguepatients starting alpha interferon/ribavirin treatment

Outcome Measures

Primary Outcomes (1)

  • Adherence to Medications Form

    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.

    HCV medication adherence reported at 12 weeks

Secondary Outcomes (1)

  • Fatigue Severity Scale (FSS)

    Biweekly for the first month, monthly thereafter

Study Arms (2)

Armodafinil

EXPERIMENTAL

Active medication

Drug: Armodafinil

Sugar pill

PLACEBO COMPARATOR

Inactive pill, matched to look like active medication

Drug: Sugar Pill

Interventions

ArmodafinilDRUG

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

Also known as: Nuvigil
Armodafinil
Sugar PillDRUG

Inactive pill, matched to look like active medication

Also known as: Placebo Comparator
Sugar pill

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

New York-Presbyterian/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hepatitis CFatigue

Interventions

ModafinilSugars

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCarbohydrates

Limitations and Caveats

It is difficult to attribute side effects to Armodafinil or placebo given patients were undergoing Hepatitis C Treatment throughout the trial.

Results Point of Contact

Title
Judith Rabkin
Organization
New York State Psychiatric Institute-Research Foundation for Mental Hygene
jgr1@cumc.columbia.edu
646-774-8075

Study Officials

  • Jeffrey Weiss, Ph.D., MS

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Stephen J. Ferrando, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist VI

Study Record Dates

First Submitted

October 13, 2011

First Posted

November 11, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 10, 2017

Results First Posted

February 10, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)