A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
1 other identifier
interventional
471
8 countries
73
Brief Summary
This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2009
73 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
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
January 14, 2016
CompletedAugust 11, 2020
January 1, 2017
1.3 years
September 10, 2009
December 8, 2015
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of "Off" Time During Waking Hours at End of Study
Percentage of "off" time during waking hours at end of study is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."
22 weeks
Secondary Outcomes (2)
"Off" Time
22 weeks
"On" Time Without Troublesome Dyskinesia
22 weeks
Study Arms (2)
IPX066
EXPERIMENTALFollowing IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
IR CD-LD
ACTIVE COMPARATORFollowing IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with idiopathic PD.
- At least 30 years old at the time of PD diagnosis.
- Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:
- Requiring a total daily IR LD dose of at least 400 mg
- Having a minimum dosing frequency of four times per day.
- 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 or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
- Allergic to Yellow Dye #5 (tartrazine).
- 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.
- A 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 and/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 (73)
Investigator 17
Birmingham, Alabama, 35233, United States
Investigator 49
Phoenix, Arizona, 85013, United States
Investigator 7
Little Rock, Arkansas, 72205, United States
Investigator 3
La Jolla, California, 92037, United States
Investigator 31
Sunnyvale, California, 94085, United States
Investigator 6
Torrance, California, 90502, United States
Investigator 51
Aurora, Colorado, 80045, United States
Investigator 10
New Haven, Connecticut, 06510, United States
Investigator 64
Bradenton, Florida, 34205, United States
Investigator 61
Hollywood, Florida, 33021, United States
Investigator 5
Ocala, Florida, 34471, United States
Investigator 15
Port Charlotte, Florida, 33980, United States
Investigator 8
Port Charlotte, Florida, 33980, United States
Investigator 4
St. Petersburg, Florida, 33713, United States
Investigator 46
Augusta, Georgia, 30912, United States
Investigator 38
Boise, Idaho, 83702, United States
Investigator 19
Chicago, Illinois, 60611, United States
Investigator 40
Chicago, Illinois, 60612, United States
Investigator 39
Des Moines, Iowa, 50309, United States
Investigator 29
Kansas City, Kansas, 66160, United States
Investigator 1
Bingham Farms, Michigan, 48025, United States
Investigator 21
New Brunswick, New Jersey, 08901, United States
Investigator 25
Albany, New York, 12208, United States
Investigator 8
Commack, New York, 11725, United States
Investigator 12
New York, New York, 10032, United States
Investigator 11
Durham, North Carolina, 27707, United States
Investigator 9
Raleigh, North Carolina, 27607, United States
Investigator 20
Cincinnati, Ohio, 45219, United States
Investigator 42
Toledo, Ohio, 43614, United States
Investigator 60
Tulsa, Oklahoma, 74137, United States
Investigator 14
Charleston, South Carolina, 29401, United States
Investigator 16
Dallas, Texas, 75390-9016, United States
Investigator 13
Houston, Texas, 77030-2744, United States
Investigator 65
Tacoma, Washington, 98405, United States
Investigator 2
Milwaukee, Wisconsin, 53233, United States
Investigator 24
London, Ontario, N6A 5A5, Canada
Investigator 18
Ottawa, Ontario, K1G 4G3, Canada
Investigator 26
Québec, Quebec, G1R 3X5, Canada
Investigator 32
Strasbourg, Alsace, 67091, France
Investigator 22
Dijon, Bourgogne-Franche-Comté, 21000, France
Investigator 52
Lille, Hauts-de-France, 59037, France
Investigator 33
Toulouse, Midi-pyrenees, 31059, France
Investigator 58
Paris, Île-de-France Region, 75013, France
Investigator 30
Sachsen, Dresden, 1307, Germany
Investigator 27
Westerstede, Lower Saxony, 26655, Germany
Investigator 23
Berlin, 10437, Germany
Investigator 72
Berlin, 12163, Germany
Investigator 28
Berlin, 13088, Germany
Investigator 67
Berlin, 13353, Germany
Investigator 48
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Investigator 37
Krakow, Lesser Poland Voivodeship, 31-530, Poland
Investigator 59
Lublin, Lublin Voivodeship, 20-718, Poland
Investigator 36
Warsaw, Masovian Voivodeship, 02-777, Poland
Investigator 54
Szczecin, West Pomeranian Voivodeship, 70-215, Poland
Investigator 35
Mosina, Wielkopoloskie, 62-050, Poland
Investigator 34
Katowice, 40-546, Poland
Investigator 69
Târgu Mureş, Mureș County, 540136, Romania
Investigator 68
Brasov, 500283, Romania
Investigator 62
Bucharest, 20125, Romania
Investigator 63
Târgu Mureş, 540136, Romania
Investigator 43
Terrassa, Barcelona, 8221, Spain
Investigator 70
Barcelona, 8028, Spain
Investigator 57
Barcelona, 8036, Spain
Investigator 45
Barcelona, 8190, Spain
Investigator 50
Madrid, 28006, Spain
Investigator 53
Madrid, 28922, Spain
Investigator 55
Dnipro, Dnipropetrovsk Oblast, 49005, Ukraine
Investigator 56
Vinnitsa, Vinnytsya, 21005, Ukraine
Investigator 47
Zaporizhzhya, Zaporizhzhya, 69600, Ukraine
Investigator 71
Donetsk, 83003, Ukraine
Investigator 44
Kharkiv, 61068, Ukraine
Investigator 66
Odesa, 65117, Ukraine
Investigator 41
Zaporizhzhya, 69035, Ukraine
Related Publications (2)
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: 30425824DERIVEDHauser RA, Hsu A, Kell S, Espay AJ, Sethi K, Stacy M, Ondo W, O'Connell M, Gupta S; IPX066 ADVANCE-PD investigators. Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: a phase 3 randomised, double-blind trial. Lancet Neurol. 2013 Apr;12(4):346-56. doi: 10.1016/S1474-4422(13)70025-5. Epub 2013 Feb 26.
PMID: 23485610DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michelle Landolfi, Director, Regulatory Affairs
- Organization
- Impax Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
Impax Study Director
Impax Laboratories, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2009
First Posted
September 11, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2011
Study Completion
March 1, 2011
Last Updated
August 11, 2020
Results First Posted
January 14, 2016
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share