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Trial record 1 of 1 for:    IPX066-B11-01
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Carbidopa-Levodopa Extended-Release (CD-LD ER) Alone or in Combination With Carbidopa-Levodopa Immediate Release (IR) to IPX066 Followed by Extension Safety Study of IPX066 in Subjects With Advanced Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01411137
First received: August 4, 2011
Last updated: September 27, 2013
Last verified: September 2013

August 4, 2011
September 27, 2013
August 2011
March 2013   (final data collection date for primary outcome measure)
  • Patient Global Impression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient reported outcome
  • Clinical Global Impression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinician reported outcome
  • Parkinson's Disease Questionnaire- 8 (PDQ-8) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Disease severity questionnaire
Same as current
Complete list of historical versions of study NCT01411137 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Carbidopa-Levodopa Extended-Release (CD-LD ER) Alone or in Combination With Carbidopa-Levodopa Immediate Release (IR) to IPX066 Followed by Extension Safety Study of IPX066 in Subjects With Advanced Parkinson's Disease
An Open Label Conversion Study of Carbidopa-Levodopa Extended-Release (CD-LD ER) Taken Alone or in Combination With Carbidopa-Levodopa Immediate Release (IR) to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Subjects With Advanced Parkinson's Disease

The purpose of this study is to find out how doses of IPX066 required to help people with Parkinson's disease compare to those required for carbidopa-levodopa sustained-release tablets (also known as Sinemet® CR).

Part 1 - This study is a multicenter open-label study. Subjects will be converted from their current treatment to IPX066 over a 6-week period. Up to 40 subjects will be enrolled in the study. Subjects will be entered into one of two cohorts. Approximately 24 subjects will enroll in Cohort 1 (non- Objective Parkinson's Disease Measurement (OPDM) subjects) and up-to 16 subjects at selected sites will enroll in Cohort 2 (OPDM/PK subjects). Along with the OPDM measurements, PK blood samples may also be collected from these subjects.

Part 2 - Following the successful completion of Part 1 of the study, eligible subjects may participate in Part 2, a 6-month open-label extension study.

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
Drug: IPX066
CD-LD extended release
Other Name: CD-LD extended release capsules
Experimental: IPX066
Intervention: Drug: IPX066
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosed with idiopathic PD without any known cause for Parkinsonism.
  2. At least 30 years old at the time of PD diagnosis.
  3. Currently being treated with:

    • an LD dosing frequency of at least four times a day
    • at least one dose of CD-LD ER daily
    • requiring a total daily LD dose of at least 400 mg
    • stable regimen for at least 4 weeks prior to Screening
  4. Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is 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.
  5. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.

Exclusion Criteria:

  1. Pregnant or breastfeeding
  2. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
  3. Nonresponsive to LD therapy.
  4. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
  5. Planning to take during participation in the clinical study: any controlled-release LD product, additional CD or benserazide, entacapone or tolcapone, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
  6. Any evidence of suicidal behavior within 6 months of entering the study.
  7. Allergic or hypersensitive to to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
  8. History of or currently active psychosis.
  9. Active or history of peptic ulcers or surgical procedure of the stomach, the small intestine or the large intestine.
  10. Active or history of narrow-angle glaucoma.
  11. History of malignant melanoma or a suspicious undiagnosed skin lesion.
  12. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
  13. Abnormal kidney function
  14. Severe hepatic impairment.
  15. Received any investigational medications during the 4 weeks prior to Screening.
  16. Previously enrolled in IPX066 studies.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01411137
IPX066-B11-01
No
IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Michael J. Fox Foundation for Parkinson's Research
Study Chair: Impax Study Director Impax Pharmaceuticals Division (Impax) , a Division of Impax Laboratories Inc.
IMPAX Laboratories, Inc.
September 2013

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