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NCT01130493 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
A Phase 3 study of Parkinson's Disease, sponsored by Impax Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 110
- Enrollment target
- 20
- Study locations
NCT01130493: Completed Phase 3 study of Parkinson's Disease, sponsored by Impax Laboratories.
NCT01130493 is a Phase 3 study of Parkinson's Disease that has completed, run by Impax Laboratories. The registered enrollment target is 110 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01130493, a Phase 3 study of Parkinson's Disease, has completed, sponsored by Impax Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 110 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
Primary Outcome
Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period. Mean percentage of "OFF" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.
Conditions Studied
Interventions
- DRUG IPX066
- DRUG CLE
Study Locations (20)
Other
- Hôpital Gabriel Montpied-Service de Neurologie A- - Clermont-Ferrand
- Service de neurologie-Hôpital de la Timone- - Marseille
- Praxis für Neurologie, Psychiatrie und Psychotherapie Achim - Achim
- Praxis Dres. Bitter/Schumann - Bochum
- Klinikum rechts der Isar der Technischen Universität München - München
- Klinik für Neurologie, Stadtroda - Stadtroda
- RKU, Neurologische Klinik der Universität Ulm - Ulm
- Casa di Cura Villa Margherita - Arcugnano
Florida
- UM Movement Disorders Center - Miami
- Charlotte Neurological Services - Port Charlotte
- USF Parkinson's and Movement Disorders Center - Tampa
California
- Margolin Brain Institute - Fresno
- The Parkinson's Institute in Sunnyvale - Sunnyvale
New York
- Parkinson's Disease and Movement Disorders Center of Long Island - Commack
- Kingston Neurological Associates - Kingston
Michigan
- Quest Research Institute - Bingham Farms
Nevada
- University Health Systems - Las Vegas
Ohio
- University Neurology, Inc - Cincinnati
Virginia
- Sentara Neurological Associates - Virginia Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT01130493 record still lists
NCT01130493 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which IPX066 is the first listed.
NCT01130493 names 20 study sites across 9 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT01130493 about?
NCT01130493 is a clinical study titled "A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066". This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
What is the current status of trial NCT01130493?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2010-05. Estimated completion is 2012-01.
What conditions does trial NCT01130493 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT01130493?
The interventions under investigation include: IPX066 (DRUG), CLE (DRUG).
Who is sponsoring clinical trial NCT01130493?
This trial is sponsored by Impax Laboratories, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01130493 being conducted?
This trial has 20 study locations across California, Florida, Michigan, Nevada, New York. 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 NCT01130493's enrollment target sits among peer trials
110 51st of 158 higher than 107 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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