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NCT00622427 · ClinicalTrials.gov registry record · Phase 4
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT00622427 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 32 participants.
The verdict
NCT00622427, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.
Interventions
- DRUG Placebo
- DRUG Ramelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00622427
The ClinicalTrials.gov registry entry for NCT00622427 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00622427 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00622427 about?
NCT00622427 is a clinical study titled "Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia". Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measure...
What is the current status of trial NCT00622427?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2008-02. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00622427?
The interventions under investigation include: Placebo (DRUG), Ramelteon (DRUG).
Who is sponsoring clinical trial NCT00622427?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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