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NCT00972075 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects

A Phase 2 study of Blindness and Non-24 Hour Sleep-Wake Disorder, sponsored by Neurim Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
13
Enrollment target
2
Study locations

NCT00972075: Completed Phase 2 study of Blindness and Non-24 Hour Sleep-Wake Disorder, sponsored by Neurim Pharmaceuticals.

NCT00972075 is a Phase 2 study of Blindness and Non-24 Hour Sleep-Wake Disorder that has completed, run by Neurim Pharmaceuticals. The registered enrollment target is 13 participants, below the 57-participant average among 7 other Blindness trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00972075, a Phase 2 study of Blindness and Non-24 Hour Sleep-Wake Disorder, has completed, sponsored by Neurim Pharmaceuticals.

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

Study Summary

The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™ 2 mg in improving total night sleep duration and stabilizing the circadian clock phase in totally blind subjects with non-24 hour sleep-wake disorder.

Interventions

  • DRUG placebo
  • DRUG melatonin (Circadin)

Study Locations (2)

Georgia

  • Sleep Disorders Center of Atlanta - Atlanta

New York

  • Clinlabs, Inc. - New York

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2006-02
Est. Completion 2007-10
Phase Phase 2
Neurim Pharmaceuticals

6 total trials

What the finished NCT00972075 record still lists

NCT00972075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 57-participant average among 7 other Blindness trials with a reported enrollment target (77% lower).

The record links to 2 conditions, with Blindness appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT00972075 reports a single indexed study location in Georgia, New York.

Frequently Asked Questions

What is clinical trial NCT00972075 about?

NCT00972075 is a clinical study titled "Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects". The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™ 2 mg in improving total night sleep duration and stabilizing the circadian clock phase in totally blind subjects with non-24 hour sleep-wake disorder.

What is the current status of trial NCT00972075?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2006-02. Estimated completion is 2007-10.

What conditions does trial NCT00972075 study?

This clinical trial studies the following conditions: Blindness, Non-24 Hour Sleep-Wake Disorder.

What interventions are being tested in trial NCT00972075?

The interventions under investigation include: placebo (DRUG), melatonin (Circadin) (DRUG).

Who is sponsoring clinical trial NCT00972075?

This trial is sponsored by Neurim Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00972075 being conducted?

This trial has 2 study locations across Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00972075, the US trial registry maintained by the National Library of Medicine. NCT00972075 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.