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NCT00614926 · ClinicalTrials.gov registry record · Phase 4
Modafinil for Treatment of Fatigue in ALS Patients
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT00614926: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT00614926 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00614926, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.
Primary Outcome
The CGI is a standardized assessment tool widely used in clinical psychopharmacology trials as an outcome measure. Scores range from 1= very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5-7 = worse. We use it as a dichotomous measure with scores of 1 or 2 signifying "responder" and all the rest as "non-responder" using all available data including clinician judgement, and ratings scales.
Interventions
- DRUG Placebo
- DRUG Modafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2006-06 |
| Est. Completion | 2008-07 |
| Phase | Phase 4 |
What the finished NCT00614926 record still lists
NCT00614926 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00614926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00614926 about?
NCT00614926 is a clinical study titled "Modafinil for Treatment of Fatigue in ALS Patients". The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.
What is the current status of trial NCT00614926?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2006-06. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00614926?
The interventions under investigation include: Placebo (DRUG), Modafinil (DRUG).
Who is sponsoring clinical trial NCT00614926?
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 NCT00614926's enrollment target sits among peer trials
32 1534th of 2000 higher than 457 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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