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NCT01096186 · ClinicalTrials.gov registry record · Phase 3

An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

A Phase 3 study of Parkinson's Disease, sponsored by Impax Laboratories.

Completed
Registry status
Phase 3
Development phase
617
Enrollment target
20
Study locations

NCT01096186 is a Phase 3 study of Parkinson's Disease that has completed, run by Impax Laboratories. The registered enrollment target is 617 participants, roughly in line with the 638-participant average among 156 other Parkinson's Disease trials with a reported enrollment target. The trial reports 20 study locations across 10 states.

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The verdict

NCT01096186, a Phase 3 study of Parkinson's Disease, has completed, sponsored by Impax Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
617 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

Conditions Studied

Parkinson's Disease

Interventions

  • DRUG IPX066 95 mg
  • DRUG IPX066 145 mg
  • DRUG IPX066 195 mg
  • DRUG IPX066 245 mg

Study Locations (20)

Florida

  • Bradenton Research Center, Inc. - Bradenton
  • Sunrise Clinical Research - Hollywood
  • Renstar Medical Research - Ocala
  • Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida - Port Charlotte
  • Suncoast Neuroscience Associates, Inc. - St. Petersburg
  • University of South Florida, Parkinson's Disease and Movement Disorders Center - Tampa

California

  • Coastal Neurological Medical Group - La Jolla
  • Coordinated Clinical Research - La Jolla
  • The Parkinson's Institute - Sunnyvale
  • Collaborative NeuroScience Network, Inc. - Torrance

Arizona

  • Mohammed Ali Parkinson's Center - Phoenix
  • HOPE Research Institute - Phoenix

Illinois

  • Northwestern University, Feinberg School of Medicine, Dept. of Neurology - Chicago
  • Rush University Medical Center - Chicago

Alabama

  • University of Alabama at Birmingham - Birmingham

Arkansas

  • Clinical Trials Inc. - Little Rock

Georgia

  • Medical College of Georgia, Movements Disorders Clinic - Augusta

Idaho

  • Movement Disorder Center at Idaho Elks Rehabilitation Hospital - Boise

Trial Details

FieldValue
Enrollment Target 617 participants
Start Date 2010-03
Est. Completion 2011-10
Phase Phase 3

Sponsor

Impax Laboratories

19 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01096186

The ClinicalTrials.gov registry entry for NCT01096186 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 617 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 638-participant average among 156 other Parkinson's Disease trials with a reported enrollment target. The listed sponsor is Impax Laboratories, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 4 interventions - of which IPX066 95 mg is the first listed.

NCT01096186 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT01096186 about?

NCT01096186 is a clinical study titled "An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease". The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

What is the current status of trial NCT01096186?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2010-03. Estimated completion is 2011-10.

What conditions does trial NCT01096186 study?

This clinical trial studies the following conditions: Parkinson's Disease.

What interventions are being tested in trial NCT01096186?

The interventions under investigation include: IPX066 95 mg (DRUG), IPX066 145 mg (DRUG), IPX066 195 mg (DRUG), IPX066 245 mg (DRUG).

Who is sponsoring clinical trial NCT01096186?

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

Where is trial NCT01096186 being conducted?

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