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NCT00488839 · ClinicalTrials.gov registry record · Phase 3

IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

A Phase 3 study, sponsored by Impax Laboratories.

Completed
Registry status
Phase 3
Development phase
173
Enrollment target

NCT00488839 is a Phase 3 study that has completed, run by Impax Laboratories. The registered enrollment target is 173 participants.

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The verdict

NCT00488839, a Phase 3 study, has completed, sponsored by Impax Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
173 participants
Enrollment target

Study Summary

The purpose of this study is to determine the effects, both good and bad, of IPX056 on subjects and their spasticity. This study will also determine the relationship between the amount of IPX056 in blood and the effects on spasticity. Lastly, this study will determine how long IPX056 affects spasticity.

Interventions

  • DRUG IPX056 20 mg
  • DRUG IPX056 40 mg
  • DRUG Encapsulated Baclofen 20 mg
  • DRUG Placebo Baclofen Tablet
  • DRUG IPX056 10 mg

Trial Details

FieldValue
Enrollment Target 173 participants
Start Date 2007-06
Est. Completion 2008-05
Phase Phase 3

Sponsor

Impax Laboratories

19 total trials

What the Registry Record Tells You About NCT00488839

The ClinicalTrials.gov registry entry for NCT00488839 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Impax Laboratories, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which IPX056 20 mg is the first listed.

NCT00488839 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00488839 about?

NCT00488839 is a clinical study titled "IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis". The purpose of this study is to determine the effects, both good and bad, of IPX056 on subjects and their spasticity. This study will also determine the relationship between the amount of IPX056 in blood and the effects on spasticity. Lastly, this study will determine how long IPX056 affects spastic...

What is the current status of trial NCT00488839?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2007-06. Estimated completion is 2008-05.

What interventions are being tested in trial NCT00488839?

The interventions under investigation include: IPX056 20 mg (DRUG), IPX056 40 mg (DRUG), Encapsulated Baclofen 20 mg (DRUG), Placebo Baclofen Tablet (DRUG), IPX056 10 mg (DRUG).

Who is sponsoring clinical trial NCT00488839?

This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.

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.