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NCT01470651 · ClinicalTrials.gov registry record · Phase 4
Armodafinil for Patients Starting Hepatitis C Virus Treatment
A Phase 4 study, sponsored by Research Foundation for Mental Hygiene.
- Terminated
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01470651: Clinical Trial Phase 4 study, sponsored by Research Foundation for Mental Hygiene.
NCT01470651 is a Phase 4 study that was terminated before completion, run by Research Foundation for Mental Hygiene. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01470651, a Phase 4 study, was terminated before completion, sponsored by Research Foundation for Mental Hygiene.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Armodafinil
- DRUG Sugar Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
Why NCT01470651 stopped before completion
NCT01470651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Armodafinil is the first listed.
NCT01470651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01470651 about?
NCT01470651 is a clinical study titled "Armodafinil for Patients Starting Hepatitis C Virus Treatment". 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...
What is the current status of trial NCT01470651?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2011-10. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01470651?
The interventions under investigation include: Armodafinil (DRUG), Sugar Pill (DRUG).
Who is sponsoring clinical trial NCT01470651?
This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01470651's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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