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NCT01857531 · ClinicalTrials.gov registry record · Phase 2

Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate

A Phase 2 study of Smoking Cessation, sponsored by Jed E. Rose.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target
4
Study locations

NCT01857531 is a Phase 2 study of Smoking Cessation that has completed, run by Jed E. Rose. The registered enrollment target is 36 participants, below the 475-participant average among 188 other Smoking Cessation trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 1 state.

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The verdict

NCT01857531, a Phase 2 study of Smoking Cessation, has completed, sponsored by Jed E. Rose.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target
4
Study locations

Study Summary

The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US.

Conditions Studied

Interventions

  • DRUG Nicotine Patch
  • DRUG Ganaxolone

Study Locations (4)

North Carolina

  • Duke Center for Smoking Cessation - Charlotte
  • Duke Center for Smoking Cessation - Durham
  • Duke Center for Smoking Cessation - Raleigh
  • Duke Center for Smoking Cessation - Winston-Salem

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2013-06
Est. Completion 2014-02
Phase Phase 2

Sponsor

Jed E. Rose

3 total trials

What the Registry Record Tells You About NCT01857531

The ClinicalTrials.gov registry entry for NCT01857531 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 475-participant average among 188 other Smoking Cessation trials with a reported enrollment target (92% lower). The listed sponsor is Jed E. Rose, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 2 interventions - of which Nicotine Patch is the first listed.

NCT01857531 reports 4 study locations spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT01857531 about?

NCT01857531 is a clinical study titled "Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate". The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US.

What is the current status of trial NCT01857531?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2013-06. Estimated completion is 2014-02.

What conditions does trial NCT01857531 study?

This clinical trial studies the following conditions: Smoking Cessation.

What interventions are being tested in trial NCT01857531?

The interventions under investigation include: Nicotine Patch (DRUG), Ganaxolone (DRUG).

Who is sponsoring clinical trial NCT01857531?

This trial is sponsored by Jed E. Rose, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01857531 being conducted?

This trial has 4 study locations across North Carolina. 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.