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Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
NCT00401284 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.
Conditions Studied
Interventions
- DRUG EVT 201
Study Locations (20)
Florida
- Miami Research Associates — Miami
- OmniTrials, 11181 Health Park Blvd, Suite 3040 — Naples
- Broward Research Group — Pembroke Pines
- Clinical Research Group of St Petersburg Inc., 2525 Pasadena Ave So, Suite S — St. Petersburg
Arizona
- PsyPharma Clinical Research Inc. — Phoenix
- PsyPharma Clinical Research, Inc. — Tucson
California
- Pacific Sleep Medicine Services Inc — Los Angeles
- Pacific Sleep Medicine Services — San Diego
Georgia
- The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center, 5505 Peachtree Dunwoody Road, Suite 548 — Atlanta
- Sleep Disorders Center of Georgia - Gainesville — Gainesville
Ohio
- Community Research — Cincinnati
- Tri-State Sleep Disorders Center, 1275 East Kemper Road — Cincinnati
Kansas
- Vince and Assocaites Clinical Research — Overland Park
Kentucky
- Community Research — Crestview Hills
Mississippi
- Center for Sleep Medicine, 101 Courtney Circle — Hattiesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2006-11 |
| Est. Completion | 2007-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00401284
The ClinicalTrials.gov registry entry for NCT00401284 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Evotec Neurosciences, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sleep Initiation and Maintenance Disorders appearing as the primary indexed condition, and to 1 intervention — of which EVT 201 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00401284 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00401284 about?
NCT00401284 is a clinical study titled "Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness". The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.
What is the current status of trial NCT00401284?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2006-11. Estimated completion is 2007-07.
What conditions does trial NCT00401284 study?
This clinical trial studies the following conditions: Sleep Initiation and Maintenance Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00401284?
The interventions under investigation include: EVT 201 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00401284?
This trial is sponsored by Evotec Neurosciences, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00401284 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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