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NCT01681121 · ClinicalTrials.gov registry record · Phase 2

A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy

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

Completed
Registry status
Phase 2
Development phase
93
Enrollment target
20
Study locations

NCT01681121 is a Phase 2 study of Narcolepsy that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 93 participants, below the 373-participant average among 12 other Narcolepsy trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT01681121, a Phase 2 study of Narcolepsy, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
93 participants
Enrollment target
20
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 (20)

Georgia

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

California

  • Stanford Sleep Medicine Center - Redwood City
  • Pacific Research Network - San Diego

Florida

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

Kentucky

  • Community Research - Crestview Hills
  • Kentucky Research Group - Louisville

Maryland

  • The Center for Sleep and Wake Disorders - Chevy Chase
  • Pulmonary and Critical Care Associates of Baltimore - Towson

North Carolina

  • Rex Sleep Disorders Center - Raleigh
  • Wake Research Associates - Raleigh

Alabama

  • Sleep Disorders Center of Alabama - Birmingham

Arizona

  • Pulmonary Associates - Phoenix

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2012-09
Est. Completion 2013-08
Phase Phase 2

Sponsor

Jazz Pharmaceuticals

128 total trials

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What the Registry Record Tells You About NCT01681121

The ClinicalTrials.gov registry entry for NCT01681121 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 373-participant average among 12 other Narcolepsy trials with a reported enrollment target (75% 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.

NCT01681121 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Georgia, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01681121 about?

NCT01681121 is a clinical study titled "A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy". 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 NCT01681121?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2012-09. Estimated completion is 2013-08.

What conditions does trial NCT01681121 study?

This clinical trial studies the following conditions: Narcolepsy.

What interventions are being tested in trial NCT01681121?

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

Who is sponsoring clinical trial NCT01681121?

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

Where is trial NCT01681121 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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.