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An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IPX066 95 mg
IPX066 145 mg
IPX066 195 mg
IPX066 245 mg
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 motor Symptoms, efficacy, IPX066, Parkinson's Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Each subject must meet the following inclusion criteria in order to be enrolled in the study:

    1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.
    2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.

Exclusion Criteria:

  • Each subject must be free of the following exclusion criteria in order to be enrolled in the study:

    1. Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
    2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
    3. Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).
    4. In the opinion of the Investigator, should not participate in the study.

Sites / Locations

  • University of Alabama at Birmingham
  • Mohammed Ali Parkinson's Center
  • HOPE Research Institute
  • Clinical Trials Inc.
  • Coastal Neurological Medical Group
  • Coordinated Clinical Research
  • The Parkinson's Institute
  • Collaborative NeuroScience Network, Inc.
  • Bradenton Research Center, Inc.
  • Sunrise Clinical Research
  • Renstar Medical Research
  • Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida
  • Suncoast Neuroscience Associates, Inc.
  • University of South Florida, Parkinson's Disease and Movement Disorders Center
  • Medical College of Georgia, Movements Disorders Clinic
  • Movement Disorder Center at Idaho Elks Rehabilitation Hospital
  • Northwestern University, Feinberg School of Medicine, Dept. of Neurology
  • Rush University Medical Center
  • Iowa Methodist Medical Center
  • University of Kansas Medical Center
  • Quest Research Institute
  • Struthers Parkinson's Center
  • UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
  • Albany Medical College, Parkinson's Disease and Movement Disorders Center
  • David L. Kreitzman, MD, P.C.
  • Columbia University Neurological Institute
  • Institute for Human Performance
  • Duke University Medical Center Movement Disorders Center
  • University Neurology, Inc.
  • University of Toledo
  • The Movement Disorder Clinic of Oklahoma
  • Medical University of South Carolina
  • University of Texas Southwestern Medical Center
  • Baylor College of Medicine
  • South Puget Sound Neurology
  • Wisconsin Institute for Neurologic and Sleep Disorders
  • London Health Sciences Centre, University Hospital
  • Parkinson's & Neurodegenerative Disorder Clinic
  • Ottawa Hospital Civic Site
  • Quebec Memory & Motor Skills Disorders Clinic
  • East Tallinn Central Hospital
  • West Tallinn Central Hospital,
  • Praxis für Neurologie und Psychiatrie
  • Neurozentrm - Praxis fur Neurologie und Psychiatrie
  • Neurologiepraxis
  • P.Stradina university hospital
  • Gailezers hospital
  • Kaunas Medical University Hospital
  • Siauliai Regional Hospital
  • National Centre of Osteoporosis
  • Vilnius University Emergency Hospital
  • Vilnius University Hospital Santariskiu klinikos
  • PALLMED Sp. z o.o.
  • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie
  • Krakowska Akademia Neurologii Sp. z o. o.
  • Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
  • Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska
  • Euromedis Sp. z o.o.
  • Neuro-Care NZOZ
  • Psychiatry and Neurology Hospital Brasov, Neurology Department
  • Neomed Research
  • Colentina Clinical Hospital Bucharest, II Neurology Department
  • CFR Clinical Hospital Constanta, Neurology Department
  • Clinical Rehabilitation Hospital Iasi, Neurology Department
  • County Clinical Emergency Hospital Targu Mures, I Neurology Department
  • County Clinical Emergency Hospital Targu Mures, II Neurology Department
  • County Clinical Emergency Hospital Timisoara, Neurology Department
  • Hospital General de Cataluña
  • Clinica Ruber SA
  • Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk 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
  • Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine
  • Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine
  • Neurology department of Lviv regional clinical hospital
  • Odessa Regional Clinical Hospital, Dept. of Neurosurgery
  • Neurology department of Medical Dental Academy based on Poltava regional hospital
  • Vinnytsia Regional Psycho-Neurological Hospital
  • Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6
  • Zaporozhye Regional Clinical Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open Label IPX066

Arm Description

Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.

Outcomes

Primary Outcome Measures

Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III
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 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

Total UPDRS Parts I-IV
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient. 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
Patient Global Impression (PGI)
Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale. Patient Global Impression 0-7 - higher value indicates increased improvement from study start

Full Information

First Posted
March 25, 2010
Last Updated
October 25, 2019
Sponsor
Impax Laboratories, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01096186
Brief Title
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
Official Title
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 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
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
Detailed Description
IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066: IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease) IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa - Levodopa) IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease) All participants will be given IPX066 for 9 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
motor Symptoms, efficacy, IPX066, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
617 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label IPX066
Arm Type
Other
Arm Description
Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.
Intervention Type
Drug
Intervention Name(s)
IPX066 95 mg
Other Intervention Name(s)
CD-LD ER 95 mg
Intervention Description
23.75 - 95 mg CD-LD capsules
Intervention Type
Drug
Intervention Name(s)
IPX066 145 mg
Other Intervention Name(s)
CD-LD ER 145 mg
Intervention Description
36.25 - 145 mg CD-LD capsules
Intervention Type
Drug
Intervention Name(s)
IPX066 195 mg
Other Intervention Name(s)
CD-LD ER195 mg
Intervention Description
48.75 - 195 mg CD-LD capsules
Intervention Type
Drug
Intervention Name(s)
IPX066 245 mg
Other Intervention Name(s)
CD-LD ER 245 mg
Intervention Description
61.25 - 245 mg CD-LD capsules
Primary Outcome Measure Information:
Title
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III
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 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
9 months
Secondary Outcome Measure Information:
Title
Total UPDRS Parts I-IV
Description
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient. 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
9 months
Title
Patient Global Impression (PGI)
Description
Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale. Patient Global Impression 0-7 - higher value indicates increased improvement from study start
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Each subject must meet the following inclusion criteria in order to be enrolled in the study: Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy. Exclusion Criteria: Each subject must be free of the following exclusion criteria in order to be enrolled in the study: Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation. Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline). In the opinion of the Investigator, should not participate in the study.
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
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Mohammed Ali Parkinson's Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Clinical Trials Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
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
Collaborative NeuroScience Network, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
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
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
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 Parkinson's Disease Treatment Center of S.W. Florida
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
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, Parkinson's Disease and Movement Disorders Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Medical College of Georgia, Movements Disorders Clinic
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Movement Disorder Center at Idaho Elks Rehabilitation Hospital
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Northwestern University, Feinberg School of Medicine, Dept. of Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
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
Albany Medical College, Parkinson's Disease and Movement Disorders Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
David L. Kreitzman, MD, P.C.
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Columbia University Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Institute for Human Performance
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
27707
Country
United States
Facility Name
University Neurology, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
The Movement Disorder Clinic of Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9184
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Puget Sound Neurology
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
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
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Parkinson's & Neurodegenerative Disorder 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
Quebec Memory & Motor Skills Disorders 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 Tallinn Central Hospital,
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Praxis für Neurologie und Psychiatrie
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
Neurozentrm - Praxis fur Neurologie und Psychiatrie
City
Berlin
ZIP/Postal Code
10437
Country
Germany
Facility Name
Neurologiepraxis
City
Berlin
ZIP/Postal Code
12163
Country
Germany
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
National Centre of Osteoporosis
City
Vilnius
ZIP/Postal Code
LT-01102
Country
Lithuania
Facility Name
Vilnius University Emergency Hospital
City
Vilnius
ZIP/Postal Code
LT-04130
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
PALLMED Sp. z o.o.
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp. z o. o.
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska
City
Mosina
State/Province
Wielkopoloskie
ZIP/Postal Code
62-050
Country
Poland
Facility Name
Euromedis Sp. z o.o.
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-215
Country
Poland
Facility Name
Neuro-Care NZOZ
City
Katowice
ZIP/Postal Code
40-546
Country
Poland
Facility Name
Psychiatry and Neurology Hospital Brasov, Neurology Department
City
Brasov
ZIP/Postal Code
500123
Country
Romania
Facility Name
Neomed Research
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Colentina Clinical Hospital Bucharest, II Neurology Department
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
CFR Clinical Hospital Constanta, Neurology Department
City
Constanta
ZIP/Postal Code
900123
Country
Romania
Facility Name
Clinical Rehabilitation Hospital Iasi, Neurology Department
City
Lasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
County Clinical Emergency Hospital Targu Mures, I Neurology Department
City
Targu Mures
ZIP/Postal Code
540136
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, Neurology Department
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Hospital General de Cataluña
City
Sant Cugat Del Valles
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Clinica Ruber SA
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk regional hospital named after Mechnikov
City
Dnipropetrovsk
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
61058
Country
Ukraine
Facility Name
Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Neurology department of Lviv regional clinical hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Odessa Regional Clinical Hospital, Dept. of Neurosurgery
City
Odesa
ZIP/Postal Code
65025
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
Vinnytsia Regional Psycho-Neurological Hospital
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Zaporozhye Regional Clinical Hospital
City
Zaporozhye
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

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