A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
1 other identifier
interventional
110
4 countries
24
Brief Summary
This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2010
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
September 13, 2017
CompletedOctober 29, 2019
September 1, 2017
1.7 years
May 24, 2010
August 3, 2016
October 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of "OFF" Time During Waking Hours
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.
3 days of data immediately prior to the end of each 2 week treatment period
Secondary Outcomes (4)
Total "OFF" Time During Waking Hours
3 days of data immediately prior to the end of each 2 week treatment period
Total "On" With No Troublesome Dyskinesia
3 days of data immediately prior to the end of each 2 week treatment period
UPDRS Part II Plus Part III
End of each double-blind treatment period.
Subject Preference
End of Study (week 11)
Study Arms (2)
IPX066-CLE-OLE
OTHERDose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2)
CLE-IPX066-OLE
OTHERDose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with idiopathic Parkinson's Disease (PD).
- At least 30 years old at the time of PD diagnosis.
- Currently being treated with carbidopa/levodopa/entacapone (CLE) and on a stable regimen of conventional LD for at least 4 weeks and:
- Requiring a total daily levodopa (LD) dose of at least 400 mg
- Having a minimum dosing frequency of four times per day.
- Individual CD-LD or CLE doses that contain an LD dose which is a multiple of 50 mg.
- Able to differentiate "on" state from "off" state.
- Have predictable "off" periods.
- Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
- Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.
You may not qualify if:
- Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
- Nonresponsive to LD therapy.
- Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
- Received within 4 weeks of Screening or planning to take during participation in the clinical study: any controlled-release LD product, tolcapone, apomorphine, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
- Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
- History of or currently active psychosis.
- Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
- Active or history of narrow-angle glaucoma.
- History of malignant melanoma or a suspicious undiagnosed skin lesion.
- History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.
- Received any investigational medications during the 4 weeks prior to Screening.
- Unable to swallow large pills (e.g., large vitamin pills).
- Pregnant or breastfeeding.
- Subjects who are unable to complete a symptom diary.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Margolin Brain Institute
Fresno, California, 93720, United States
The Parkinson's Institute in Sunnyvale
Sunnyvale, California, 94085, United States
UM Movement Disorders Center
Miami, Florida, 33136, United States
Charlotte Neurological Services
Port Charlotte, Florida, 33980, United States
USF Parkinson's and Movement Disorders Center
Tampa, Florida, 33606, United States
Quest Research Institute
Bingham Farms, Michigan, 48025, United States
University Health Systems
Las Vegas, Nevada, 89102, United States
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, 11725, United States
Kingston Neurological Associates
Kingston, New York, 12401, United States
University Neurology, Inc
Cincinnati, Ohio, 45219, United States
Sentara Neurological Associates
Virginia Beach, Virginia, 23456, United States
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034, United States
Hôpital Gabriel Montpied-Service de Neurologie A-
Clermont-Ferrand, 63003, France
Service de neurologie-Hôpital de la Timone-
Marseille, 13385, France
Praxis für Neurologie, Psychiatrie und Psychotherapie Achim
Achim, 28832, Germany
Praxis Dres. Bitter/Schumann
Bochum, 44805, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Klinik für Neurologie, Stadtroda
Stadtroda, 07646, Germany
RKU, Neurologische Klinik der Universität Ulm
Ulm, 89081, Germany
Casa di Cura Villa Margherita
Arcugnano, 36057, Italy
San Raffaele Cassino, San Raffaele Cassino,
Cassino, 03043, Italy
Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio
Chieti, 66013, Italy
Ospedale della Misericordia
Grosseto, 58100, Italy
IRCCS San Raffaele Pisana
Roma, 163, Italy
Related Publications (1)
Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018.
PMID: 30425824DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kaihong Jiang, Senior Director, Head of Biometrics
- Organization
- Impax Laboratories, LLC
Study Officials
- STUDY DIRECTOR
Impax Study Director
Impax Laboratories, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2010
First Posted
May 26, 2010
Study Start
May 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
October 29, 2019
Results First Posted
September 13, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share