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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 21, 2016
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: IR CD-LD
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:
  • Percentage of "Off" Time During Waking Hours at End of Study [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
    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 Hours [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
    "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 ] [ Designated as safety issue: No ]
    "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
extended-release carbidopa-levodopa
Drug: IPX066
extended-release carbidopa-levodopa capsules
Other Name: ER CD-LD
Active Comparator: IR CD-LD
immediate-release carbidopa-levodopa
Drug: IR CD-LD
immediate-release carbidopa-levodopa capsules
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 regular CD-LD, followed by a 6-week dose-conversion period to IPX066.
  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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

  Show 73 Study Locations
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 21, 2016
Health Authority: United States: Food and Drug Administration
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
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
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 September 26, 2016