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A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease (APEX-PD)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
IPX066 95 mg LD
IPX066 145 mg LD
IPX066 195 mg LD
IPX066 245 mg 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. Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable.
  2. Diagnosed with idiopathic PD.
  3. LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
  4. If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation.
  5. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
  6. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.

Exclusion Criteria:

  1. Pregnant or breastfeeding.
  2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
  3. Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
  4. Use of nonselective MAO inhibitors.
  5. Use of dopamine agonists within 30 days prior to Screening.
  6. Unable to tolerate a placebo regimen, in the Investigator's opinion.
  7. Treatment of psychosis with any antipsychotic.
  8. History of seizure or epilepsy.
  9. Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
  10. History of narrow-angle glaucoma.
  11. Subjects with a history of malignant melanoma.
  12. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
  13. Received any investigational medications during the 30 days prior to Screening.

Sites / Locations

  • University of Alabama at Birmingham, Dept. of Neurology
  • HOPE Research Institute, LLC
  • Collaborative NeuroScience Network, Inc.
  • Coastal Neurological Medical Group
  • Coordinated Clinical Research
  • The Parkinson's Institute
  • Yale Neurology Clinics, Temple Medical Center
  • Bradenton Research Center, Inc.
  • Sunrise Clinical Research, Inc.
  • Renstar Medical Research
  • Charlotte Neurological Services
  • Suncoast Neuroscience Associates, Inc.
  • University of South Florida
  • Idaho Elks Rehabilitation Hospital
  • Rush University Medical Center, Dept. of Neurological Sciences
  • Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center
  • Boston University School of Medicine
  • Quest Research Institute
  • Struthers Parkinson's Center
  • UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
  • Mount Sinai School of Medicine
  • Columbia University
  • State University of New York Upstate Medical University, Dept. of Neurology
  • Duke University Medical Center Movement Disorders Center
  • University of Toledo
  • Baylor College of Medicine, Parkinson's Disease Center
  • Wisconsin Institute for Neurologic and Sleep Disorders
  • Movement Disorders Clinic, Glenrose Rehabilitation Hospital
  • Saint Boniface Clinic
  • London Health Science Center
  • Parkinson's and Neurodegenerative Disorders Clinic
  • Ottawa Hospital Civic Site
  • Toronto Western Hospital
  • University of Sherbrooke
  • Memory and Motor Skills Clinic
  • East Tallinn Central Hospital
  • West Tallin Central Hopsital
  • P.Stradina university hospital
  • Gailezers hospital
  • Kaunas Medical University Hospital
  • Siauliai Regional Hospital
  • Vilnius University Emergency Hospital
  • Vilnius University Centre of Gerontology and Rehabilitation
  • Vilnius University Hospital Santariskiu klinikos
  • Psychiatry and Neurology Hospital, Neurology Department
  • Colentina Clinical Hospital Bucharest, II Neurology Department
  • County Emergency Clinical Hospital Cluj-Napoca, I Neurology Clinic
  • CFR Clinical Hospital Constanta
  • Clinical Rehabilitation Hospital Iasi, Neurology Department
  • County Clinical Emergency Hospital, Targu Mures, II Neurology Department,
  • County Clinical Emergency Hospital Timisoara
  • Neurology department of Regional hospital named after Mechnikov
  • Department of Psychiatry and Medical Psychology of Donetsk National Medical University
  • Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
  • 1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
  • Institute of Gerontology Parkinson's Disease Center
  • Neurology department of Lviv regional clinical hospital
  • Neurology department of Medical Dental Academy based on Poltava regional hospital
  • Neurology department of Vinnitsa Medical University
  • Neurology department, Zaporozhye State Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

IPX066 145 mg LD

IPX066 245 mg LD

IPX066 390 mg LD

Arm Description

One Placebo capsule was given TID for the first 21 days. Two placebo capsules were given TID on days 22 till end of study (week 30).

One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).

One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).

One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).

Outcomes

Primary Outcome Measures

Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study). Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25

Secondary Outcome Measures

Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Change from Baseline in Parkinson's disease Questionnaire 39 (PDQ-39) at Weeks 4, 9, 16, 23 and 30 or early discontinuation was collected. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of "Never" (better in outcome), (value 0), "Occasionally" (value 1), "Sometimes" (value 2), , "Often" (value 3), and "Always" (value 4), (worse in outcome). The minimum possible score is "0" and the maximum is "156". The outcome measure calculated was the change from baseline to end of study in mean PDQ-39 score. Negative values indicate a better result.

Full Information

First Posted
April 3, 2009
Last Updated
October 25, 2019
Sponsor
Impax Laboratories, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00880620
Brief Title
A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
Acronym
APEX-PD
Official Title
A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (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 study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.
Detailed Description
A randomized, double-blind, placebo-controlled, fixed-dose, parallel-arm study of three doses of IPX066 versus placebo. Total of 427 subjects were screened and 381 were randomized and received one of the four treatment groups (1) placebo (N=92), (2) IPX066 145 mg LD (N=87) (3) IPX066 245 mg LD (N=104) (4) IPX066 390 mg LD (N=98) three times a day. Study duration is approximately 30 weeks for each subject including 4 weeks of titration (up to 3 weeks of dose escalation and I week of stabilization for safe escalation to the allocated dose), and 26 weeks of maintenance. During the titration phase: The following dose strengths were used to titrate up to the final three strengths that were assigned to the three IPX066 treatment arms. IPX066 95 mg LD capsule containing 95 mg LD and 23.75 mg CD. IPX066 145 mg LD capsule containing 145 mg LD and 36.25 mg CD. IPX066 195 mg LD capsule containing 195 mg LD and 48.75 mg CD. IPX066 245 mg LD capsule containing 245 mg LD and 61.25 mg CD. During the maintenance phase: IPX066 145 mg LD treatment arm received 145 mg LD and 36.25 mg CD. IPX066 245 mg LD treatment arm received 245 mg LD and 61.25 mg CD. IPX066 390 mg LD treatment arm received 390 mg LD and 97.50 mg CD. Primary efficacy outcome measure was change from baseline in the sum of UPDRS Part II and Part III scores at the end of study or last value reported if subject discontinued prematurely. Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score.

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
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One Placebo capsule was given TID for the first 21 days. Two placebo capsules were given TID on days 22 till end of study (week 30).
Arm Title
IPX066 145 mg LD
Arm Type
Experimental
Arm Description
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
Arm Title
IPX066 245 mg LD
Arm Type
Experimental
Arm Description
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
Arm Title
IPX066 390 mg LD
Arm Type
Experimental
Arm Description
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
IPX066 95 mg LD
Other Intervention Name(s)
CD-LD ER 95 mg
Intervention Description
IPX066 capsule containing 95 mg LD/23.75 mg CD
Intervention Type
Drug
Intervention Name(s)
IPX066 145 mg LD
Other Intervention Name(s)
CD-LD ER 145 mg
Intervention Description
IPX066 capsule containing 145 mg LD/36.25 mg CD
Intervention Type
Drug
Intervention Name(s)
IPX066 195 mg LD
Other Intervention Name(s)
CD-LD ER 195 mg
Intervention Description
IPX066 capsule containing 195 mg LD/48.75 mg CD
Intervention Type
Drug
Intervention Name(s)
IPX066 245 mg LD
Other Intervention Name(s)
CD-LD ER 245 mg
Intervention Description
IPX066 capsule containing 245 mg LD/61.25 mg CD
Primary Outcome Measure Information:
Title
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
Description
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study). Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25
Time Frame
Week 30
Secondary Outcome Measure Information:
Title
Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Description
Change from Baseline in Parkinson's disease Questionnaire 39 (PDQ-39) at Weeks 4, 9, 16, 23 and 30 or early discontinuation was collected. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of "Never" (better in outcome), (value 0), "Occasionally" (value 1), "Sometimes" (value 2), , "Often" (value 3), and "Always" (value 4), (worse in outcome). The minimum possible score is "0" and the maximum is "156". The outcome measure calculated was the change from baseline to end of study in mean PDQ-39 score. Negative values indicate a better result.
Time Frame
Baseline and Week 30 (or End of Study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable. Diagnosed with idiopathic PD. LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment. If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls. Exclusion Criteria: Pregnant or breastfeeding. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome. Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation. Use of nonselective MAO inhibitors. Use of dopamine agonists within 30 days prior to Screening. Unable to tolerate a placebo regimen, in the Investigator's opinion. Treatment of psychosis with any antipsychotic. History of seizure or epilepsy. Active or prior medical condition or prior surgical procedure that would interfere with LD absorption. History of narrow-angle glaucoma. Subjects with a history of malignant melanoma. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome. Received any investigational medications during the 30 days prior to Screening.
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
University of Alabama at Birmingham, Dept. of Neurology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
HOPE Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Collaborative NeuroScience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Coastal Neurological Medical Group
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Coordinated Clinical Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
The Parkinson's Institute
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
Yale Neurology Clinics, Temple Medical Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Bradenton Research Center, Inc.
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Sunrise Clinical Research, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
23021
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Charlotte Neurological Services
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Idaho Elks Rehabilitation Hospital
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Rush University Medical Center, Dept. of Neurological Sciences
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7314
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Struthers Parkinson's Center
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
State University of New York Upstate Medical University, Dept. of Neurology
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University Medical Center Movement Disorders Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Baylor College of Medicine, Parkinson's Disease Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wisconsin Institute for Neurologic and Sleep Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Movement Disorders Clinic, Glenrose Rehabilitation Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Facility Name
Saint Boniface Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3J2H7
Country
Canada
Facility Name
London Health Science Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Parkinson's and Neurodegenerative Disorders Clinic
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 4G3
Country
Canada
Facility Name
Ottawa Hospital Civic Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
University of Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Memory and Motor Skills Clinic
City
Quebec
ZIP/Postal Code
G1R 3X5
Country
Canada
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
West Tallin Central Hopsital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
P.Stradina university hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Gailezers hospital
City
Riga
Country
Latvia
Facility Name
Kaunas Medical University Hospital
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Siauliai Regional Hospital
City
Siauliai
ZIP/Postal Code
LT- 76231
Country
Lithuania
Facility Name
Vilnius University Emergency Hospital
City
Vilnius
ZIP/Postal Code
LT-04130
Country
Lithuania
Facility Name
Vilnius University Centre of Gerontology and Rehabilitation
City
Vilnius
ZIP/Postal Code
LT-08420
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Psychiatry and Neurology Hospital, Neurology Department
City
Brasov
ZIP/Postal Code
500123
Country
Romania
Facility Name
Colentina Clinical Hospital Bucharest, II Neurology Department
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
County Emergency Clinical Hospital Cluj-Napoca, I Neurology Clinic
City
Cluj Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
CFR Clinical Hospital Constanta
City
Constanta
ZIP/Postal Code
900123
Country
Romania
Facility Name
Clinical Rehabilitation Hospital Iasi, Neurology Department
City
Iasi
Country
Romania
Facility Name
County Clinical Emergency Hospital, Targu Mures, II Neurology Department,
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
County Clinical Emergency Hospital Timisoara
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Neurology department of Regional hospital named after Mechnikov
City
Dnepropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Department of Psychiatry and Medical Psychology of Donetsk National Medical University
City
Donetsk
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
City
Kharkiv
ZIP/Postal Code
Kharkiv
Country
Ukraine
Facility Name
Institute of Gerontology Parkinson's Disease Center
City
Kiev
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Neurology department of Lviv regional clinical hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Neurology department of Medical Dental Academy based on Poltava regional hospital
City
Poltava
ZIP/Postal Code
36000
Country
Ukraine
Facility Name
Neurology department of Vinnitsa Medical University
City
Vinnitsa
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Neurology department, Zaporozhye State Medical University
City
Zaporozhye
ZIP/Postal Code
69035
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24055014
Citation
Pahwa R, Lyons KE, Hauser RA, Fahn S, Jankovic J, Pourcher E, Hsu A, O'Connell M, Kell S, Gupta S; APEX-PD Investigators. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease. Parkinsonism Relat Disord. 2014 Feb;20(2):142-8. doi: 10.1016/j.parkreldis.2013.08.017. Epub 2013 Sep 5.
Results Reference
background

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A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease

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