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

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ClinicalTrials.gov Identifier: NCT01096186
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : March 3, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: IPX066 95 mg Drug: IPX066 145 mg Drug: IPX066 195 mg Drug: IPX066 245 mg Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 617 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
Study Start Date : March 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Open Label IPX066
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.
Drug: IPX066 95 mg
23.75 - 95 mg CD-LD capsules
Other Name: CD-LD ER 95 mg

Drug: IPX066 145 mg
36.25 - 145 mg CD-LD capsules
Other Name: CD-LD ER 145 mg

Drug: IPX066 195 mg
48.75 - 195 mg CD-LD capsules
Other Name: CD-LD ER195 mg

Drug: IPX066 245 mg
61.25 - 245 mg CD-LD capsules
Other Name: CD-LD ER 245 mg




Primary Outcome Measures :
  1. Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III [ Time Frame: 9 months ]

    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 :
  1. Total UPDRS Parts I-IV [ Time Frame: 9 months ]

    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


  2. Patient Global Impression (PGI) [ Time Frame: 9 months ]

    Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale.

    Patient Global Impression 0-7 - higher value indicates increased improvement from study start




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096186


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Mohammed Ali Parkinson's Center
Phoenix, Arizona, United States, 85013
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, Arkansas
Clinical Trials Inc.
Little Rock, Arkansas, United States, 72205
United States, California
Coastal Neurological Medical Group
La Jolla, California, United States, 92037
Coordinated Clinical Research
La Jolla, California, United States, 92037
The Parkinson's Institute
Sunnyvale, California, United States, 94085
Collaborative NeuroScience Network, Inc.
Torrance, California, United States, 90502
United States, Florida
Bradenton Research Center, Inc.
Bradenton, Florida, United States, 34205
Sunrise Clinical Research
Hollywood, Florida, United States, 33021
Renstar Medical Research
Ocala, Florida, United States, 34471
Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida
Port Charlotte, Florida, United States, 33980
Suncoast Neuroscience Associates, Inc.
Saint Petersburg, Florida, United States, 33713
University of South Florida, Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33603
United States, Georgia
Medical College of Georgia, Movements Disorders Clinic
Augusta, Georgia, United States, 30912
United States, Idaho
Movement Disorder Center at Idaho Elks Rehabilitation Hospital
Boise, Idaho, United States, 83702
United States, Illinois
Northwestern University, Feinberg School of Medicine, Dept. of Neurology
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Minnesota
Struthers Parkinson's Center
Golden Valley, Minnesota, United States, 55427
United States, New Jersey
UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
New Brunswick, New Jersey, United States, 08901
United States, New York
Albany Medical College, Parkinson's Disease and Movement Disorders Center
Albany, New York, United States, 12208
David L. Kreitzman, MD, P.C.
Commack, New York, United States, 11725
Columbia University Neurological Institute
New York, New York, United States, 10032
Institute for Human Performance
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center Movement Disorders Center
Durham, North Carolina, United States, 27707
United States, Ohio
University Neurology, Inc.
Cincinatti, Ohio, United States, 45219
University of Toledo
Toledo, Ohio, United States, 43614
United States, Oklahoma
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29401
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9184
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
South Puget Sound Neurology
Tacoma, Washington, United States, 98405
United States, Wisconsin
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, United States, 53233
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
Parkinson's & Neurodegenerative Disorder Clinic
Ottawa, Ontario, Canada, K1G 4G3
Ottawa Hospital Civic Site
Ottawa, Ontario, Canada, K1Y 4E9
Canada
Quebec Memory & Motor Skills Disorders Clinic
Quebec, Canada, G1R 3X5
Estonia
East Tallinn Central Hospital
Tallinn, Estonia, 10138
West Tallinn Central Hospital,
Tallinn, Estonia, 10617
Germany
Praxis für Neurologie und Psychiatrie
Westerstede, Niedersachsen, Germany, 26655
Neurozentrm - Praxis fur Neurologie und Psychiatrie
Berlin, Germany, 10437
Neurologiepraxis
Berlin, Germany, 12163
Latvia
P.Stradina university hospital
Riga, Latvia, 1002
Gailezers hospital
Riga, Latvia
Lithuania
Kaunas Medical University Hospital
Kaunas, Lithuania, LT-50009
Siauliai Regional Hospital
Siauliai, Lithuania, LT-76231
National Centre of Osteoporosis
Vilnius, Lithuania, LT-01102
Vilnius University Emergency Hospital
Vilnius, Lithuania, LT-04130
Vilnius University Hospital Santariskiu klinikos
Vilnius, Lithuania, LT-08661
Poland
PALLMED Sp. z o.o.
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie
Lublin, Lubelskie, Poland, 20-718
Krakowska Akademia Neurologii Sp. z o. o.
Kraków, Malopolskie, Poland, 31-530
Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
Warszawa, Mazowieckie, Poland, 02-777
Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska
Mosina, Wielkopoloskie, Poland, 62-050
Euromedis Sp. z o.o.
Szczecin, Zachodniopomorskie, Poland, 70-215
Neuro-Care NZOZ
Katowice, Poland, 40-546
Romania
Psychiatry and Neurology Hospital Brasov, Neurology Department
Brasov, Romania, 500123
Neomed Research
Brasov, Romania, 500283
Colentina Clinical Hospital Bucharest, II Neurology Department
Bucharest, Romania, 020125
CFR Clinical Hospital Constanta, Neurology Department
Constanta, Romania, 900123
Clinical Rehabilitation Hospital Iasi, Neurology Department
Lasi, Romania, 700661
County Clinical Emergency Hospital Targu Mures, I Neurology Department
Targu Mures, Romania, 540136
County Clinical Emergency Hospital Targu Mures, II Neurology Department
Targu Mures, Romania, 540136
County Clinical Emergency Hospital Timisoara, Neurology Department
Timisoara, Romania, 300736
Spain
Hospital General de Cataluña
Sant Cugat Del Valles, Barcelona, Spain, 08195
Clinica Ruber SA
Madrid, Spain, 28006
Ukraine
Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk regional hospital named after Mechnikov
Dnipropetrovsk, Ukraine, 49005
Department of Psychiatry and Medical Psychology of Donetsk National Medical University
Donetsk, Ukraine, 83037
Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
Donetsk, Ukraine, 83099
1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
Kharkiv, Ukraine, 61058
Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine
Kharkiv, Ukraine, 61068
Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine
Kharkiv, Ukraine, 61068
Neurology department of Lviv regional clinical hospital
Lviv, Ukraine, 79010
Odessa Regional Clinical Hospital, Dept. of Neurosurgery
Odesa, Ukraine, 65025
Neurology department of Medical Dental Academy based on Poltava regional hospital
Poltava,, Ukraine, 36000
Vinnytsia Regional Psycho-Neurological Hospital
Vinnytsia, Ukraine, 21005
Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6
Zaporizhzhya, Ukraine, 69035
Zaporozhye Regional Clinical Hospital
Zaporozhye, Ukraine, 69600
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Study Director: IPX066-B09-03 Impax Study Director Impax Pharmaceuticals, a division of Impax Laboratories

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01096186     History of Changes
Other Study ID Numbers: IPX066-B09-03
First Posted: March 31, 2010    Key Record Dates
Results First Posted: March 3, 2016
Last Update Posted: March 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by IMPAX Laboratories, Inc.:
motor Symptoms
efficacy
IPX066
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Carbidopa
Levodopa
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors