Back to resultsA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IPX066
CLE
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
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 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.
Sites / Locations
- Margolin Brain Institute
- The Parkinson's Institute in Sunnyvale
- UM Movement Disorders Center
- Charlotte Neurological Services
- USF Parkinson's and Movement Disorders Center
- Quest Research Institute
- University Health Systems
- Parkinson's Disease and Movement Disorders Center of Long Island
- Kingston Neurological Associates
- University Neurology, Inc
- Sentara Neurological Associates
- Booth Gardner Parkinson's Care Center
- Hôpital Gabriel Montpied-Service de Neurologie A-
- Service de neurologie-Hôpital de la Timone-
- Praxis für Neurologie, Psychiatrie und Psychotherapie Achim
- Praxis Dres. Bitter/Schumann
- Klinikum rechts der Isar der Technischen Universität München
- Klinik für Neurologie, Stadtroda
- RKU, Neurologische Klinik der Universität Ulm
- Casa di Cura Villa Margherita
- San Raffaele Cassino, San Raffaele Cassino,
- Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio
- Ospedale della Misericordia
- IRCCS San Raffaele Pisana
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
IPX066-CLE-OLE
CLE-IPX066-OLE
Arm Description
Dose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2)
Dose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total "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 Total "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.
Total "On" With No Troublesome Dyskinesia
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 Total "On" with No Troublesome Dyskinesia was calculated. "On" Time is when medication is providing benefit with regard to mobility, slowness, and stiffness.
UPDRS Part II Plus Part III
Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108.
The UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility.
Subject Preference
Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01130493
Brief Title
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
Official Title
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (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 compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.
Detailed Description
This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPX066-CLE-OLE
Arm Type
Other
Arm Description
Dose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2)
Arm Title
CLE-IPX066-OLE
Arm Type
Other
Arm Description
Dose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)
Intervention Type
Drug
Intervention Name(s)
IPX066
Other Intervention Name(s)
extended-release carbidopa-levodopa
Intervention Description
experimental product
Intervention Type
Drug
Intervention Name(s)
CLE
Other Intervention Name(s)
carbidopa/levodopa/entacapone
Intervention Description
active comparator
Primary Outcome Measure Information:
Title
Percentage of "OFF" Time During Waking Hours
Description
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.
Time Frame
3 days of data immediately prior to the end of each 2 week treatment period
Secondary Outcome Measure Information:
Title
Total "OFF" Time During Waking Hours
Description
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 Total "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.
Time Frame
3 days of data immediately prior to the end of each 2 week treatment period
Title
Total "On" With No Troublesome Dyskinesia
Description
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 Total "On" with No Troublesome Dyskinesia was calculated. "On" Time is when medication is providing benefit with regard to mobility, slowness, and stiffness.
Time Frame
3 days of data immediately prior to the end of each 2 week treatment period
Title
UPDRS Part II Plus Part III
Description
Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108.
The UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility.
Time Frame
End of each double-blind treatment period.
Title
Subject Preference
Description
Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.
Time Frame
End of Study (week 11)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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 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.
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
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
The Parkinson's Institute in Sunnyvale
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
UM Movement Disorders Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Charlotte Neurological Services
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
USF Parkinson's and Movement Disorders Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
University Health Systems
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Long Island
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Kingston Neurological Associates
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
University Neurology, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Sentara Neurological Associates
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Booth Gardner Parkinson's Care Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Hôpital Gabriel Montpied-Service de Neurologie A-
City
Clermont-Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Service de neurologie-Hôpital de la Timone-
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Praxis für Neurologie, Psychiatrie und Psychotherapie Achim
City
Achim
ZIP/Postal Code
28832
Country
Germany
Facility Name
Praxis Dres. Bitter/Schumann
City
Bochum
ZIP/Postal Code
44805
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinik für Neurologie, Stadtroda
City
Stadtroda
ZIP/Postal Code
07646
Country
Germany
Facility Name
RKU, Neurologische Klinik der Universität Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Casa di Cura Villa Margherita
City
Arcugnano
ZIP/Postal Code
36057
Country
Italy
Facility Name
San Raffaele Cassino, San Raffaele Cassino,
City
Cassino
ZIP/Postal Code
03043
Country
Italy
Facility Name
Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Ospedale della Misericordia
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
IRCCS San Raffaele Pisana
City
Roma
ZIP/Postal Code
163
Country
Italy
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
Learn more about this trial
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
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