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NCT00922272 · ClinicalTrials.gov registry record · Phase 2

Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms

A Phase 2 study, sponsored by Shire.

Completed
Registry status
Phase 2
Development phase
92
Enrollment target

NCT00922272 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 92 participants.

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The verdict

NCT00922272, a Phase 2 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 2
Development phase
92 participants
Enrollment target

Study Summary

To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).

Interventions

  • DRUG SPD489 (lisdexamfetamine dimesylate)
  • DRUG Placebo matching SPD489 (lisdexamfetamine dimesylate)

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2009-09-14
Est. Completion 2011-01-20
Phase Phase 2

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00922272

The ClinicalTrials.gov registry entry for NCT00922272 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which SPD489 (lisdexamfetamine dimesylate) is the first listed.

NCT00922272 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00922272 about?

NCT00922272 is a clinical study titled "Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms". To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).

What is the current status of trial NCT00922272?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2009-09-14. Estimated completion is 2011-01-20.

What interventions are being tested in trial NCT00922272?

The interventions under investigation include: SPD489 (lisdexamfetamine dimesylate) (DRUG), Placebo matching SPD489 (lisdexamfetamine dimesylate) (DRUG).

Who is sponsoring clinical trial NCT00922272?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.