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NCT01485770 · ClinicalTrials.gov registry record · Phase 2

A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

A Phase 2 study of Narcolepsy, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
33
Enrollment target
10
Study locations

NCT01485770 is a Phase 2 study of Narcolepsy that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 33 participants, below the 378-participant average among 12 other Narcolepsy trials with a reported enrollment target (91% lower). The trial reports 10 study locations across 7 states.

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The verdict

NCT01485770, a Phase 2 study of Narcolepsy, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
33 participants
Enrollment target
10
Study locations

Study Summary

This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.

Conditions Studied

Narcolepsy

Interventions

  • DRUG Placebo
  • DRUG ADX-N05

Study Locations (10)

Georgia

  • Neurotrials Research, Inc. - Atlanta
  • Sleep Disorders Center of Georgia - Atlanta
  • SleepMed of Central Georgia - Macon

Texas

  • Future Search Trials of Neurology - Austin
  • Sleep Medicine Associates of Texas - Dallas

Arizona

  • Pulmonary Associates - Phoenix

Florida

  • Clinical Research Group of St. Petersburg - St. Petersburg

Maryland

  • The Center for Sleep and Wake Disorders - Chevy Chase

Ohio

  • Mercy St. Anne Sleep Disorders Center - Toledo

South Carolina

  • SleepMed of South Carolina - Columbia

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2011-12
Est. Completion 2012-05
Phase Phase 2

Sponsor

Jazz Pharmaceuticals

128 total trials

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What the Registry Record Tells You About NCT01485770

The ClinicalTrials.gov registry entry for NCT01485770 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 378-participant average among 12 other Narcolepsy trials with a reported enrollment target (91% lower). The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Narcolepsy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01485770 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Georgia, Texas, Arizona.

Frequently Asked Questions

What is clinical trial NCT01485770 about?

NCT01485770 is a clinical study titled "A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness". This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.

What is the current status of trial NCT01485770?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2011-12. Estimated completion is 2012-05.

What conditions does trial NCT01485770 study?

This clinical trial studies the following conditions: Narcolepsy.

What interventions are being tested in trial NCT01485770?

The interventions under investigation include: Placebo (DRUG), ADX-N05 (DRUG).

Who is sponsoring clinical trial NCT01485770?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01485770 being conducted?

This trial has 10 study locations across Arizona, Florida, Georgia, Maryland, Ohio. 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.