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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 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.

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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

Primary Insomnia

Interventions

  • BEHAVIORAL CBT-I
  • DRUG modafinil

Study Locations (1)

New York

  • University of Rochester Sleep and Neurophysiology Research Lab - Rochester

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2005-01
Est. Completion 2007-08
Phase Phase 4

Sponsor

University of Rochester

636 total trials

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What the Registry Record Tells You About NCT00124384

The ClinicalTrials.gov registry entry for NCT00124384 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 123-participant average among 12 other Primary Insomnia trials with a reported enrollment target (67% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.