A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
- Registration Number
- NCT00974974
- Lead Sponsor
- Impax Laboratories, LLC
- Brief Summary
This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.
- Detailed Description
A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 471
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IPX066 IR CD-LD Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066. IR CD-LD IPX066 Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator). IR CD-LD IR CD-LD Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator). IPX066 IPX066 Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
- Primary Outcome Measures
Name Time Method Percentage of "Off" Time During Waking Hours at End of Study 22 weeks 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)."
- Secondary Outcome Measures
Name Time Method "Off" Time 22 weeks "Off" time hours 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)."
"On" Time Without Troublesome Dyskinesia 22 weeks "On" time without troublesome dyskinesiais measured by using the Parkinson's disease diary. "On" time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living."
Trial Locations
- Locations (72)
Investigator 7
🇺🇸Little Rock, Arkansas, United States
Investigator 64
🇺🇸Bradenton, Florida, United States
Investigator 4
🇺🇸Saint Petersburg, Florida, United States
Investigator 21
🇺🇸New Brunswick, New Jersey, United States
Investigator 33
🇫🇷Toulouse, Midi-pyrenees, France
Investigator 56
🇺🇦Vinnitsa, Vinnytsya, Ukraine
Investigator 47
🇺🇦Zaporozhye, Zaporizhzhya, Ukraine
Investigator 37
🇵🇱Kraków, Malopolskie, Poland
Investigator 36
🇵🇱Warszawa, Mazowieckie, Poland
Investigator 34
🇵🇱Katowice, Poland
Investigator 63
🇷🇴Târgu Mureş, Romania
Investigator 55
🇺🇦Dnepropetrovsk, Dnipropetrovsk, Ukraine
Investigator 44
🇺🇦Kharkiv, Ukraine
Investigator 41
🇺🇦Zaporozhye, Ukraine
Investigator 35
🇵🇱Mosina, Wielkopoloskie, Poland
Investigator 38
🇺🇸Boise, Idaho, United States
Investigator 24
🇨🇦London, Ontario, Canada
Investigator 67
🇩🇪Berlin, Germany
Investigator 42
🇺🇸Toledo, Ohio, United States
Investigator 14
🇺🇸Charleston, South Carolina, United States
Investigator 1
🇺🇸Bingham Farms, Michigan, United States
Investigator 20
🇺🇸Cincinnati, Ohio, United States
Investigator 25
🇺🇸Albany, New York, United States
Investigator 16
🇺🇸Dallas, Texas, United States
Investigator 12
🇺🇸New York, New York, United States
Investigator 13
🇺🇸Houston, Texas, United States
Investigator 32
🇫🇷Strasbourg Cedex, Alsace, France
Investigator 26
🇨🇦Quebec, Canada
Investigator 22
🇫🇷Dijon, Bourgogne, France
Investigator 52
🇫🇷Lille, NORD Pas-de-calais, France
Investigator 30
🇩🇪Sachsen, Dresden, Germany
Investigator 27
🇩🇪Westerstede, Niedersachsen, Germany
Investigator 72
🇩🇪Berlin, Germany
Investigator 28
🇩🇪Berlin, Germany
Investigator 48
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Investigator 59
🇵🇱Lublin, Lubelskie, Poland
Investigator 54
🇵🇱Szczecin, Zachodniopomorskie, Poland
Investigator 69
🇷🇴Târgu-Mureş, Mures, Romania
Investigator 68
🇷🇴Brasov, Romania
Investigator 62
🇷🇴Bucuresti, Romania
Investigator 43
🇪🇸Terrassa, Barcelona, Spain
Investigator 57
🇪🇸Barcelona, Spain
Investigator 70
🇪🇸Barcelona, Spain
Investigator 50
🇪🇸Madrid, Spain
Investigator 45
🇪🇸Barcelona, Spain
Investigator 53
🇪🇸Madrid, Spain
Investigator 71
🇺🇦Donetsk, Ukraine
Investigator 66
🇺🇦Odessa, Ukraine
Investigator 29
🇺🇸Kansas City, Kansas, United States
Investigator 46
🇺🇸Augusta, Georgia, United States
Investigator 19
🇺🇸Chicago, Illinois, United States
Investigator 39
🇺🇸Des Moines, Iowa, United States
Investigator 31
🇺🇸Sunnyvale, California, United States
Investigator 9
🇺🇸Raleigh, North Carolina, United States
Investigator 8
🇺🇸Commack, New York, United States
Investigator 5
🇺🇸Ocala, Florida, United States
Investigator 61
🇺🇸Hollywood, Florida, United States
Investigator 3
🇺🇸La Jolla, California, United States
Investigator 6
🇺🇸Torrance, California, United States
Investigator 23
🇩🇪Berlin, Germany
Investigator 58
🇫🇷Paris, Ile-de-france, France
Investigator 18
🇨🇦Ottawa, Ontario, Canada
Investigator 65
🇺🇸Tacoma, Washington, United States
Investigator 40
🇺🇸Chicago, Illinois, United States
Investigator 15
🇺🇸Port Charlotte, Florida, United States
Investigator 17
🇺🇸Birmingham, Alabama, United States
Investigator 49
🇺🇸Phoenix, Arizona, United States
Investigator 51
🇺🇸Aurora, Colorado, United States
Investigator 10
🇺🇸New Haven, Connecticut, United States
Investigator 11
🇺🇸Durham, North Carolina, United States
Investigator 2
🇺🇸Milwaukee, Wisconsin, United States
Investigator 60
🇺🇸Tulsa, Oklahoma, United States