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NCT00124384 · ClinicalTrials.gov registry record · Phase 4
The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
A Phase 4 study of Primary Insomnia, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00124384: Completed Phase 4 study of Primary Insomnia, sponsored by University of Rochester.
NCT00124384 is a Phase 4 study of Primary Insomnia that has completed, run by University of Rochester. The registered enrollment target is 40 participants, below the 123-participant average among 12 other Primary Insomnia trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00124384, a Phase 4 study of Primary Insomnia, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This study examines how treatment with the drug modafinil, by itself or in combination with cognitive behavioral treatment for insomnia (CBT-I), may improve daytime functioning and/or diminish the severity of insomnia.
Conditions Studied
Interventions
- BEHAVIORAL CBT-I
- DRUG modafinil
Study Locations (1)
New York
- University of Rochester Sleep and Neurophysiology Research Lab - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-01 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
What the finished NCT00124384 record still lists
NCT00124384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 123-participant average among 12 other Primary Insomnia trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Primary Insomnia appearing as the primary indexed condition, and to 2 interventions - of which CBT-I is the first listed.
NCT00124384 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00124384 about?
NCT00124384 is a clinical study titled "The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia". This study examines how treatment with the drug modafinil, by itself or in combination with cognitive behavioral treatment for insomnia (CBT-I), may improve daytime functioning and/or diminish the severity of insomnia.
What is the current status of trial NCT00124384?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2005-01. Estimated completion is 2007-08.
What conditions does trial NCT00124384 study?
This clinical trial studies the following conditions: Primary Insomnia.
What interventions are being tested in trial NCT00124384?
The interventions under investigation include: CBT-I (BEHAVIORAL), modafinil (DRUG).
Who is sponsoring clinical trial NCT00124384?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00124384 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00124384's enrollment target sits among peer trials
40 7th of 12 higher than 6 of 12 other Primary Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Insomnia 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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