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

October 25, 2019 updated by: Impax Laboratories, LLC
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

617

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • CD-LD ER 95 mg
Drug: IPX066 145 mg
36.25 - 145 mg CD-LD capsules
Other Names:
  • CD-LD ER 145 mg
Drug: IPX066 195 mg
48.75 - 195 mg CD-LD capsules
Other Names:
  • CD-LD ER195 mg
Drug: IPX066 245 mg
61.25 - 245 mg CD-LD capsules
Other Names:
  • CD-LD ER 245 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months
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
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Impax Laboratories, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

March 25, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

March 31, 2010

Study Record Updates

Last Update Posted (Actual)

November 8, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPX066-B09-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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