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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: Completed Phase 3 study of Parkinson's Disease, sponsored by Impax Laboratories.
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 631-participant average among 158 other Parkinson's Disease trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study. Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Mo
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 617 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT01096186 record still lists
NCT01096186 is an interventional study that assigns participants to a tested intervention. The registered 617 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 631-participant average among 158 other Parkinson's Disease trials with a reported enrollment target.
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Parkinson's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01096186's enrollment target sits among peer trials
617 13th of 158 higher than 146 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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