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

September 10, 2009
January 21, 2016
September 2009
January 2011   (final data collection date for primary outcome measure)
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)."
Parkinson's Disease Patient Diary [ Time Frame: Weeks 1-22 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00974974 on ClinicalTrials.gov Archive Site
  • "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."
Not Provided
Not Provided
Not Provided
 
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease
This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: IPX066
    extended-release carbidopa-levodopa capsules
    Other Name: ER CD-LD
  • Drug: IR CD-LD
    immediate-release carbidopa-levodopa capsules
    Other Name: immediate-release carbidopa-levodopa
  • Experimental: IPX066
    extended-release carbidopa-levodopa
    Intervention: Drug: IPX066
  • Active Comparator: IR CD-LD
    immediate-release carbidopa-levodopa
    Intervention: Drug: IR CD-LD
Hauser RA, Hsu A, Kell S, Espay AJ, Sethi K, Stacy M, Ondo W, O'Connell M, Gupta S; IPX066 ADVANCE-PD investigators. Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: a phase 3 randomised, double-blind trial. Lancet Neurol. 2013 Apr;12(4):346-56. doi: 10.1016/S1474-4422(13)70025-5. Epub 2013 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
471
March 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   Poland,   Romania,   Spain,   Ukraine
 
NCT00974974
IPX066-B09-02
No
No
Not Provided
IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Not Provided
Study Director: Impax Study Director Impax Pharmaceuticals, a division of Impx Laboratories.
IMPAX Laboratories, Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP