A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

This study has been completed.
Sponsor:
Information provided by:
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00869791
First received: March 24, 2009
Last updated: October 29, 2010
Last verified: October 2010

March 24, 2009
October 29, 2010
February 2009
June 2009   (final data collection date for primary outcome measure)
Pharmacokinetics: CD and LD Cmax, Tmax, AUC, half-life [ Time Frame: 2x 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00869791 on ClinicalTrials.gov Archive Site
Safety (electrocardiogram, clinical laboratory tests, vital signs, AEs) and Pharmacodynamics (finger tapping, walking, UPDRS) [ Time Frame: 2x 1 Week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa
A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

This study compares the pharmacokinetics and effectiveness of IPX066 to standard cabridopa-levodopa

This is a randomized, open-label, multicenter, 2 period, crossover study. Approximately 24 qualified LD experienced Parkinson's disease (PD) subjects are equally randomized to 1 of 2 dosing sequences.

During each treatment period subjects receive 7 days of medication. Pharmacokinetics and pharmacodynamic measures are assessed during each treatment period. Additionally, subject diaries are completed.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: IPX066
    IPX066
    Other Name: CD-LD ER
  • Drug: CD-LD
    CD-LD
  • Experimental: 1
    IPX066
    Intervention: Drug: IPX066
  • Active Comparator: 2
    CD-LD
    Intervention: Drug: CD-LD
Hauser RA, Ellenbogen AL, Metman LV, Hsu A, O'Connell MJ, Modi NB, Yao HM, Kell SH, Gupta SK. Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Mov Disord. 2011 Oct;26(12):2246-52. Epub 2011 Jul 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
August 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.
  2. If female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
  3. At least 30 years old at the time of diagnosis of PD.
  4. Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.
  5. A responder to LD and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release CD LD for at least 1 month.
  6. Must have predictable fluctuations between "on" and "off" states.
  7. Hoehn and Yahr Stage I-IV when "on".
  8. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
  9. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.

Exclusion Criteria:

  1. Pregnant or breastfeeding.
  2. Diagnosed with atypical parkinsonism.
  3. History, physical findings or laboratory results suggesting a diagnosis other than PD.
  4. Allergic or nonresponsive to previous CD-LD therapy.
  5. Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the Investigator's opinion, may jeopardize the subject's safety.
  6. Exposure to any investigational agent within 30 days prior to Visit 1.
  7. Donated blood or plasma within 28 days.

20. Had prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).

Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00869791
IPX066-B08-11
No
Jeff Mulchahey, PhD/Sr. Director Regulatory Affairs, IMPAX Laboratories
IMPAX Laboratories, Inc.
Not Provided
Not Provided
IMPAX Laboratories, Inc.
October 2010

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