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NCT00118378 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 115
- Enrollment target
NCT00118378: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT00118378 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 115 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00118378, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 115 participants
- Enrollment target
Study Summary
This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.
Primary Outcome
The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue.
Interventions
- DRUG Placebo
- DRUG Modafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2004-12 |
| Est. Completion | 2010-11 |
| Phase | Phase 4 |
What the finished NCT00118378 record still lists
NCT00118378 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00118378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00118378 about?
NCT00118378 is a clinical study titled "Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS". This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.
What is the current status of trial NCT00118378?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 115 participants. The study started on 2004-12. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00118378?
The interventions under investigation include: Placebo (DRUG), Modafinil (DRUG).
Who is sponsoring clinical trial NCT00118378?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00118378's enrollment target sits among peer trials
115 718th of 2000 higher than 1,281 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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