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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: January 20, 2017
Last verified: January 2017
  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: IR CD-LD Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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:
  • Percentage of "Off" Time During Waking Hours at End of Study [ Time Frame: 22 weeks ]
    Percentage of "off" time during waking hours at end of study is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."


Secondary Outcome Measures:
  • "Off" Time [ Time Frame: 22 weeks ]
    "Off" time hours is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."

  • "On" Time Without Troublesome Dyskinesia [ Time Frame: 22 weeks ]
    "On" time without troublesome dyskinesiais measured by using the Parkinson's disease diary. "On" time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living."


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
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
Drug: IPX066
extended-release carbidopa-levodopa capsules
Other Name: ER CD-LD
Drug: IR CD-LD
immediate-release carbidopa-levodopa tablets
Other Name: immediate-release carbidopa-levodopa
Active Comparator: IR CD-LD
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
Drug: IPX066
extended-release carbidopa-levodopa capsules
Other Name: ER CD-LD
Drug: IR CD-LD
immediate-release carbidopa-levodopa tablets
Other Name: immediate-release 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 IR CD-LD, followed by a 6-week dose-conversion period to IPX066.
  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Investigator 17
Birmingham, Alabama, United States, 35233
United States, Arizona
Investigator 49
Phoenix, Arizona, United States, 85013
United States, Arkansas
Investigator 7
Little Rock, Arkansas, United States, 72205
United States, California
Investigator 3
La Jolla, California, United States, 92037
Investigator 31
Sunnyvale, California, United States, 94085
Investigator 6
Torrance, California, United States, 90502
United States, Colorado
Investigator 51
Aurora, Colorado, United States, 80045
United States, Connecticut
Investigator 10
New Haven, Connecticut, United States, 06510
United States, Florida
Investigator 64
Bradenton, Florida, United States, 34205
Investigator 61
Hollywood, Florida, United States, 33021
Investigator 5
Ocala, Florida, United States, 34471
Investigator 15
Port Charlotte, Florida, United States, 33980
Investigator 8
Port Charlotte, Florida, United States, 33980
Investigator 4
Saint Petersburg, Florida, United States, 33713
United States, Georgia
Investigator 46
Augusta, Georgia, United States, 30912
United States, Idaho
Investigator 38
Boise, Idaho, United States, 83702
United States, Illinois
Investigator 19
Chicago, Illinois, United States, 60611
Investigator 40
Chicago, Illinois, United States, 60612
United States, Iowa
Investigator 39
Des Moines, Iowa, United States, 50309
United States, Kansas
Investigator 29
Kansas City, Kansas, United States, 66160
United States, Michigan
Investigator 1
Bingham Farms, Michigan, United States, 48025
United States, New Jersey
Investigator 21
New Brunswick, New Jersey, United States, 08901
United States, New York
Investigator 25
Albany, New York, United States, 12208
Investigator 8
Commack, New York, United States, 11725
Investigator 12
New York, New York, United States, 10032
United States, North Carolina
Investigator 11
Durham, North Carolina, United States, 27707
Investigator 9
Raleigh, North Carolina, United States, 27607
United States, Ohio
Investigator 20
Cincinatti, Ohio, United States, 45219
Investigator 42
Toledo, Ohio, United States, 43614
United States, Oklahoma
Investigator 60
Tulsa, Oklahoma, United States, 74137
United States, South Carolina
Investigator 14
Charleston, South Carolina, United States, 29401
United States, Texas
Investigator 16
Dallas, Texas, United States, 75390-9016
Investigator 13
Houston, Texas, United States, 77030-2744
United States, Washington
Investigator 65
Tacoma, Washington, United States, 98405
United States, Wisconsin
Investigator 2
Milwaukee, Wisconsin, United States, 53233
Canada, Ontario
Investigator 24
London, Ontario, Canada, N6A 5A5
Investigator 18
Ottawa, Ontario, Canada, K1G 4G3
Canada
Investigator 26
Quebec, Canada, G1R 3X5
France
Investigator 32
Strasbourg Cedex, Alsace, France, 67091
Investigator 22
Dijon, Bourgogne, France, 21000
Investigator 58
Paris, Ile-de-france, France, 75013
Investigator 33
Toulouse, Midi-pyrenees, France, 31059
Investigator 52
Lille, Nord Pas-de-calais, France, 59037
Germany
Investigator 30
Sachsen, Dresden, Germany, 1307
Investigator 27
Westerstede, Niedersachsen, Germany, 26655
Investigator 23
Berlin, Germany, 10437
Investigator 72
Berlin, Germany, 12163
Investigator 28
Berlin, Germany, 13088
Investigator 67
Berlin, Germany, 13353
Poland
Investigator 48
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
Investigator 59
Lublin, Lubelskie, Poland, 20-718
Investigator 37
Kraków, Malopolskie, Poland, 31-530
Investigator 36
Warszawa, Mazowieckie, Poland, 02-777
Investigator 35
Mosina, Wielkopoloskie, Poland, 62-050
Investigator 54
Szczecin, Zachodniopomorskie, Poland, 70-215
Investigator 34
Katowice, Poland, 40-546
Romania
Investigator 69
Tirgu Mures, Mures, Romania, 540136
Investigator 68
Brasov, Romania, 500283
Investigator 62
Bucuresti, Romania, 20125
Investigator 63
Târgu Mureş, Romania, 540136
Spain
Investigator 43
Terrassa, Barcelona, Spain, 8221
Investigator 70
Barcelona, Spain, 8028
Investigator 57
Barcelona, Spain, 8036
Investigator 45
Barcelona, Spain, 8190
Investigator 50
Madrid, Spain, 28006
Investigator 53
Madrid, Spain, 28922
Ukraine
Investigator 55
Dnepropetrovsk, Dnipropetrovsk, Ukraine, 49005
Investigator 56
Vinnitsa, Vinnytsya, Ukraine, 21005
Investigator 47
Zaporozhye, Zaporizhzhya, Ukraine, 69600
Investigator 71
Donetsk, Ukraine, 83003
Investigator 44
Kharkiv, Ukraine, 61068
Investigator 66
Odessa, Ukraine, 65117
Investigator 41
Zaporozhye, Ukraine, 69035
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Study Director: Impax Study Director Impax Pharmaceuticals, a division of Impx Laboratories.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: December 8, 2015
Last Updated: January 20, 2017
Individual Participant Data  
Plan to Share IPD: No

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
Carbidopa, levodopa drug combination
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists

ClinicalTrials.gov processed this record on June 27, 2017