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A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IPX066
IR CD-LD
Sponsored by
Impax Laboratories, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigator 17
  • Investigator 49
  • Investigator 7
  • Investigator 3
  • Investigator 31
  • Investigator 6
  • Investigator 51
  • Investigator 10
  • Investigator 64
  • Investigator 61
  • Investigator 5
  • Investigator 15
  • Investigator 8
  • Investigator 4
  • Investigator 46
  • Investigator 38
  • Investigator 19
  • Investigator 40
  • Investigator 39
  • Investigator 29
  • Investigator 1
  • Investigator 21
  • Investigator 25
  • Investigator 8
  • Investigator 12
  • Investigator 11
  • Investigator 9
  • Investigator 20
  • Investigator 42
  • Investigator 60
  • Investigator 14
  • Investigator 16
  • Investigator 13
  • Investigator 65
  • Investigator 2
  • Investigator 24
  • Investigator 18
  • Investigator 26
  • Investigator 32
  • Investigator 22
  • Investigator 58
  • Investigator 33
  • Investigator 52
  • Investigator 30
  • Investigator 27
  • Investigator 23
  • Investigator 72
  • Investigator 28
  • Investigator 67
  • Investigator 48
  • Investigator 59
  • Investigator 37
  • Investigator 36
  • Investigator 35
  • Investigator 54
  • Investigator 34
  • Investigator 69
  • Investigator 68
  • Investigator 62
  • Investigator 63
  • Investigator 43
  • Investigator 70
  • Investigator 57
  • Investigator 45
  • Investigator 50
  • Investigator 53
  • Investigator 55
  • Investigator 56
  • Investigator 47
  • Investigator 71
  • Investigator 44
  • Investigator 66
  • Investigator 41

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPX066

IR CD-LD

Arm Description

Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.

Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).

Outcomes

Primary Outcome Measures

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)."

Secondary Outcome Measures

"Off" Time
"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
"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."

Full Information

First Posted
September 10, 2009
Last Updated
August 7, 2020
Sponsor
Impax Laboratories, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00974974
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impax Laboratories, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPX066
Arm Type
Experimental
Arm Description
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
Arm Title
IR CD-LD
Arm Type
Active Comparator
Arm Description
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
Intervention Type
Drug
Intervention Name(s)
IPX066
Other Intervention Name(s)
ER CD-LD
Intervention Description
extended-release carbidopa-levodopa capsules
Intervention Type
Drug
Intervention Name(s)
IR CD-LD
Other Intervention Name(s)
immediate-release carbidopa-levodopa
Intervention Description
immediate-release carbidopa-levodopa tablets
Primary Outcome Measure Information:
Title
Percentage of "Off" Time During Waking Hours at End of Study
Description
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)."
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
"Off" Time
Description
"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)."
Time Frame
22 weeks
Title
"On" Time Without Troublesome Dyskinesia
Description
"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."
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Impax Study Director
Organizational Affiliation
Impax Laboratories, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Investigator 17
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Investigator 49
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Investigator 7
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigator 3
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigator 31
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
Investigator 6
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Investigator 51
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Investigator 10
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Investigator 64
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Investigator 61
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Investigator 5
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Investigator 15
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Investigator 8
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Investigator 4
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Investigator 46
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Investigator 38
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Investigator 19
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Investigator 40
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigator 39
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Investigator 29
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Investigator 1
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Investigator 21
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Investigator 25
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Investigator 8
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Investigator 12
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Investigator 11
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Name
Investigator 9
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Investigator 20
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Investigator 42
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Investigator 60
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Facility Name
Investigator 14
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Investigator 16
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9016
Country
United States
Facility Name
Investigator 13
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2744
Country
United States
Facility Name
Investigator 65
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Investigator 2
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Investigator 24
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Investigator 18
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 4G3
Country
Canada
Facility Name
Investigator 26
City
Quebec
ZIP/Postal Code
G1R 3X5
Country
Canada
Facility Name
Investigator 32
City
Strasbourg Cedex
State/Province
Alsace
ZIP/Postal Code
67091
Country
France
Facility Name
Investigator 22
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21000
Country
France
Facility Name
Investigator 58
City
Paris
State/Province
Ile-de-france
ZIP/Postal Code
75013
Country
France
Facility Name
Investigator 33
City
Toulouse
State/Province
Midi-pyrenees
ZIP/Postal Code
31059
Country
France
Facility Name
Investigator 52
City
Lille
State/Province
NORD Pas-de-calais
ZIP/Postal Code
59037
Country
France
Facility Name
Investigator 30
City
Sachsen
State/Province
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Investigator 27
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
Investigator 23
City
Berlin
ZIP/Postal Code
10437
Country
Germany
Facility Name
Investigator 72
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Investigator 28
City
Berlin
ZIP/Postal Code
13088
Country
Germany
Facility Name
Investigator 67
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Investigator 48
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Investigator 59
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Investigator 37
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Investigator 36
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Investigator 35
City
Mosina
State/Province
Wielkopoloskie
ZIP/Postal Code
62-050
Country
Poland
Facility Name
Investigator 54
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-215
Country
Poland
Facility Name
Investigator 34
City
Katowice
ZIP/Postal Code
40-546
Country
Poland
Facility Name
Investigator 69
City
Târgu-Mureş
State/Province
Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Investigator 68
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Investigator 62
City
Bucuresti
ZIP/Postal Code
20125
Country
Romania
Facility Name
Investigator 63
City
Târgu Mureş
ZIP/Postal Code
540136
Country
Romania
Facility Name
Investigator 43
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
8221
Country
Spain
Facility Name
Investigator 70
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Facility Name
Investigator 57
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Investigator 45
City
Barcelona
ZIP/Postal Code
8190
Country
Spain
Facility Name
Investigator 50
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Investigator 53
City
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Investigator 55
City
Dnepropetrovsk
State/Province
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Investigator 56
City
Vinnitsa
State/Province
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Investigator 47
City
Zaporozhye
State/Province
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Investigator 71
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
Investigator 44
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Investigator 66
City
Odessa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
Investigator 41
City
Zaporozhye
ZIP/Postal Code
69035
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30425824
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.
Results Reference
derived
PubMed Identifier
23485610
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.
Results Reference
derived

Learn more about this trial

A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

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