A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00974974
First received: September 10, 2009
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

This is a study to evaluate the safety and efficacy of IPX066 in Advanced Parkinson's Disease.


Condition Intervention Phase
Parkinson's Disease
Drug: IPX066
Drug: regular carbidopa-levodopa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by IMPAX Laboratories, Inc.:

Primary Outcome Measures:
  • Parkinson's Disease Patient Diary [ Time Frame: Weeks 1-22 ] [ Designated as safety issue: No ]

Enrollment: 471
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPX066
IPX066
Drug: IPX066
IPX066
Active Comparator: regular Carbidopa-Levodopa
regular Carbidopa-Levodopa
Drug: regular carbidopa-levodopa
regular carbidopa-levodopa

Detailed Description:

A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week Dose-Adjustment period for regular CD-LD, followed by a 6-week Dose-Conversion period to IPX066.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with idiopathic PD.
  2. At least 30 years old at the time of PD diagnosis.
  3. Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:

    • Requiring a total daily IR LD dose of at least 400 mg
    • Having a minimum dosing frequency of four times per day.
  4. Able to differentiate "on" state from "off" state.
  5. Have predictable "off" periods.
  6. 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.
  7. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.

Exclusion Criteria:

  1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
  2. Nonresponsive to LD therapy.
  3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
  4. Received within 4 weeks or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
  5. Allergic to Yellow Dye #5 (tartrazine).
  6. History of or currently active psychosis.
  7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
  8. Active or history of narrow-angle glaucoma.
  9. A history of malignant melanoma or a suspicious undiagnosed skin lesion.
  10. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
  11. Received any investigational medications during the 4 weeks prior to Screening.
  12. Unable to swallow large pills (e.g., large vitamin pills).
  13. Pregnant or breastfeeding.
  14. Subjects who are unable to complete a symptom diary.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974974

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham, Dept. of Neurology
Birmingham, Alabama, United States, 35233
United States, Arizona
Mohammed Ali Parkinson's Center
Phoenix, Arizona, United States, 85013
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
The Parkinson's Institute
Sunnyvale, California, United States, 94085
Collaborative Neuroscience Network, Inc.
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Health Sciences Center, School of Medicine
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Neurology Clinics, Temple Medical Center
New Haven, Connecticut, United States, 06510
United States, Florida
Bradenton Research Center Inc.
Bradenton, Florida, United States, 34205
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States, 33021
Renstar Medical Research
Ocala, Florida, United States, 34471
University of S. Florida
Port Charlotte, Florida, United States, 33980
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
United States, Georgia
Medical College of Georgia, Movements Disorders Clinic
Augusta, Georgia, United States, 30912
United States, Idaho
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, Dept. of Neurological Sciences
Chicago, Illinois, United States, 60612
United States, Iowa
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
United States, Kansas
Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center
Kansas City, Kansas, United States, 66160
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
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
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
United States, North Carolina
Duke University Medical Center Movement Disorders Center
Durham, North Carolina, United States, 27707
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
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, 74137
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29401
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-9016
Baylor College of Medicine, Parkinson's Disease Center
Houston, Texas, United States, 77030-2744
United States, Washington
Puget Sound Neurology
Tacoma, Washington, United States, 98405
United States, Wisconsin
Wisconsin Institute for Neurologic & Sleep Disorders, S.C.
Milwaukee, Wisconsin, United States, 53233
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
Parkinson's and Neurodegenerative Disorder Clinic
Ottawa, Ontario, Canada, K1G 4G3
Canada
Quebec memory & Motor Skills Disorders Clinic
Quebec, Canada, G1R 3X5
France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg Cedex, Alsace, France, 67091
Cabinet de Neurologie
Dijon, Bourgogne, France, 21000
Hôpital de la Pitié Salpêtrière
Paris, Ile-de-france, France, 75013
Centre Hospitalier Universitaire Purpan
Toulouse, Midi-pyrenees, France, 31059
Centre Hospitalier Regional Universitaire de Lille - Hôpital Salengro
Lille, Nord Pas-de-calais, France, 59037
Germany
Medizinische Fakultaet der TU Dresden, Fachbereich Neurologie
Sachsen, Dresden, Germany, 1307
Neurological and Psychiatric Practice
Westerstede, Niedersachsen, Germany, 26655
Neurozentrm - Praxis fur Neurologie und Psychiatrie
Berlin, Germany, 10437
Charité Campus Virchow Klinikum
Berlin, Germany, 13353
Neurologie Berlin
Berlin, Germany, 12163
St. Joseph Hospital Berin-Weibensee
Berlin, Germany, 13088
Poland
Regionalny Zespół Opieki Paliatywnej-Dom Sue Ryder w Bydgoszczy
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego, 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
Spitalul Clinic Judetean de Urgenta Targu-Mures, Clinica Neurologie I
Tirgu Mures, Mures, Romania, 540136
Neomed Research
Brasov, Romania, 500283
Spitalul Clinic Colentina Clinica de Neurologie
Bucuresti, Romania, 20125
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, Romania, 540136
Spain
Hospital Mutua de Terrassa, Unidad de Demencias
Terrassa, Barcelona, Spain, 8221
Hospital General de Cataluña, Dept. de Neurologia
Barcelona, Spain, 8190
Hospital Clinic i Provincial de Barcelona, Servicio de Neurología
Barcelona, Spain, 8036
Institut Universitari Dexeus
Barcelona, Spain, 8028
Clinica Ruber SA
Madrid, Spain, 28006
Hospital Universitário Fundación Alcorcón
Madrid, Spain, 28922
Ukraine
Regional Clinical Hospital n.a. I.I. Mechnikov
Dnepropetrovsk, Dnipropetrovsk, Ukraine, 49005
Vinnitsa State Medical University
Vinnitsa, Vinnytsya, Ukraine, 21005
Zaporozhye Regional Clinical Hospital
Zaporozhye, Zaporizhzhya, Ukraine, 69600
Donetsk National Medical University
Donetsk, Ukraine, 83003
Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine
Kharkiv, Ukraine, 61068
Odessa Regional Clinical Hospital
Odessa, Ukraine, 65117
Zaporozhye State Medical University based at Zaporozhye State Clinical Hospital #6
Zaporozhye, Ukraine, 69035
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Study Director: Impax Study Director Impax Pharmaceuticals, a division of Impx Laboratories.
  More Information

No publications provided

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00974974     History of Changes
Other Study ID Numbers: IPX066-B09-02
Study First Received: September 10, 2009
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by IMPAX Laboratories, Inc.:
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
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 20, 2014