Clinical trial NCT00974974: A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
Official title: A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 471
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with idiopathic PD.
2. At least 30 years old at the time of PD diagnosis.
3. 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.
4. Able to differentiate "on" state from "off" state.
5. Have predictable "off" periods.
6. 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.
7. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.

Exclusion Criteria:

1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
2. Nonresponsive to LD therapy.
3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
4. 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.
5. Allergic to Yellow Dye #5 (tartrazine).
6. History of or currently active psychosis.
7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
8. Active or history of narrow-angle glaucoma.
9. A history of malignant melanoma or a suspicious undiagnosed skin lesion.
10. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
11. Received any investigational medications during the 4 weeks prior to Screening.
12. Unable to swallow large pills (e.g., large vitamin pills).
13. Pregnant or breastfeeding.
14. Subjects who are unable to complete a symptom diary.

Primary outcomes:
measure: Percentage of "Off" Time During Waking Hours at End of Study
timeFrame: 22 weeks
Secondary outcomes:
measure: "Off" Time
timeFrame: 22 weeks
measure: "On" Time Without Troublesome Dyskinesia
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigator 17
state: Alabama
city: Phoenix
country: United States
facility: Investigator 49
state: Arizona
city: Little Rock
country: United States
facility: Investigator 7
state: Arkansas
city: La Jolla
country: United States
facility: Investigator 3
state: California
city: Sunnyvale
country: United States
facility: Investigator 31
state: California
city: Torrance
country: United States
facility: Investigator 6
state: California
city: Aurora
country: United States
facility: Investigator 51
state: Colorado
city: New Haven
country: United States
facility: Investigator 10
state: Connecticut
city: Bradenton
country: United States
facility: Investigator 64
state: Florida
city: Hollywood
country: United States
facility: Investigator 61
state: Florida
city: Ocala
country: United States
facility: Investigator 5
state: Florida
city: Port Charlotte
country: United States
facility: Investigator 15
state: Florida
city: Port Charlotte
country: United States
facility: Investigator 8
state: Florida
city: Saint Petersburg
country: United States
facility: Investigator 4
state: Florida
city: Augusta
country: United States
facility: Investigator 46
state: Georgia
city: Boise
country: United States
facility: Investigator 38
state: Idaho
city: Chicago
country: United States
facility: Investigator 19
state: Illinois
city: Chicago
country: United States
facility: Investigator 40
state: Illinois
city: Des Moines
country: United States
facility: Investigator 39
state: Iowa
city: Kansas City
country: United States
facility: Investigator 29
state: Kansas
city: Bingham Farms
country: United States
facility: Investigator 1
state: Michigan
city: New Brunswick
country: United States
facility: Investigator 21
state: New Jersey
city: Albany
country: United States
facility: Investigator 25
state: New York
city: Commack
country: United States
facility: Investigator 8
state: New York
city: New York
country: United States
facility: Investigator 12
state: New York
city: Durham
country: United States
facility: Investigator 11
state: North Carolina
city: Raleigh
country: United States
facility: Investigator 9
state: North Carolina
city: Cincinnati
country: United States
facility: Investigator 20
state: Ohio
city: Toledo
country: United States
facility: Investigator 42
state: Ohio
city: Tulsa
country: United States
facility: Investigator 60
state: Oklahoma
city: Charleston
country: United States
facility: Investigator 14
state: South Carolina
city: Dallas
country: United States
facility: Investigator 16
state: Texas
city: Houston
country: United States
facility: Investigator 13
state: Texas
city: Tacoma
country: United States
facility: Investigator 65
state: Washington
city: Milwaukee
country: United States
facility: Investigator 2
state: Wisconsin
city: London
country: Canada
facility: Investigator 24
state: Ontario
city: Ottawa
country: Canada
facility: Investigator 18
state: Ontario
city: Quebec
country: Canada
facility: Investigator 26
city: Strasbourg Cedex
country: France
facility: Investigator 32
state: Alsace
city: Dijon
country: France
facility: Investigator 22
state: Bourgogne
city: Paris
country: France
facility: Investigator 58
state: Ile-de-france
city: Toulouse
country: France
facility: Investigator 33
state: Midi-pyrenees
city: Lille
country: France
facility: Investigator 52
state: NORD Pas-de-calais
city: Sachsen
country: Germany
facility: Investigator 30
state: Dresden
city: Westerstede
country: Germany
facility: Investigator 27
state: Niedersachsen
city: Berlin
country: Germany
facility: Investigator 23
city: Berlin
country: Germany
facility: Investigator 72
city: Berlin
country: Germany
facility: Investigator 28
city: Berlin
country: Germany
facility: Investigator 67
city: Bydgoszcz
country: Poland
facility: Investigator 48
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Investigator 59
state: Lubelskie
city: Kraków
country: Poland
facility: Investigator 37
state: Malopolskie
city: Warszawa
country: Poland
facility: Investigator 36
state: Mazowieckie
city: Mosina
country: Poland
facility: Investigator 35
state: Wielkopoloskie
city: Szczecin
country: Poland
facility: Investigator 54
state: Zachodniopomorskie
city: Katowice
country: Poland
facility: Investigator 34
city: Târgu-Mureş
country: Romania
facility: Investigator 69
state: Mures
city: Brasov
country: Romania
facility: Investigator 68
city: Bucuresti
country: Romania
facility: Investigator 62
city: Târgu Mureş
country: Romania
facility: Investigator 63
city: Terrassa
country: Spain
facility: Investigator 43
state: Barcelona
city: Barcelona
country: Spain
facility: Investigator 70
city: Barcelona
country: Spain
facility: Investigator 57
city: Barcelona
country: Spain
facility: Investigator 45
city: Madrid
country: Spain
facility: Investigator 50
city: Madrid
country: Spain
facility: Investigator 53
city: Dnepropetrovsk
country: Ukraine
facility: Investigator 55
state: Dnipropetrovsk
city: Vinnitsa
country: Ukraine
facility: Investigator 56
state: Vinnytsya
city: Zaporozhye
country: Ukraine
facility: Investigator 47
state: Zaporizhzhya
city: Donetsk
country: Ukraine
facility: Investigator 71
city: Kharkiv
country: Ukraine
facility: Investigator 44
city: Odessa
country: Ukraine
facility: Investigator 66
city: Zaporozhye
country: Ukraine
facility: Investigator 41
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Hauser 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.