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Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study

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: April 18, 2017
Last verified: April 2017
  Purpose

The study had three distinct parts and is described as follows:

Part 1:

  • To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD IR to IPX066 in subjects with advanced PD
  • To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an exploratory computer-based system, in assessing dexterity and mobility in a subset of PD subjects.

Part 2:

• To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions in eligible subjects who successfully completed Part 1 of the study.

Part 3:

• To further evaluate the long-term safety of IPX066 in eligible subjects who successfully completed Part 2.


Condition Intervention Phase
Parkinson's Disease Drug: IPX066 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PD

Resource links provided by NLM:


Further study details as provided by IMPAX Laboratories, Inc.:

Primary Outcome Measures:
  • Patient Global Impression (PGI) [ Time Frame: 6 months ]
    At Part 1 Week 6, Part 2 Month 3 and Month 6 or at Early Termination, the subjects rated the change in their condition with IPX066 treatment from their condition prior to Part 1 Visit 1(Baseline) using Patient Global Impression (PGI) 7-point scale. 1=very much worse and 7=very much improved.

  • Clinical Global Impression (CGI) [ Time Frame: 6 months ]

    Clinician-reported satisfaction outcome of IPX066 using Clinical Global Impression (PGI) 7-point scale.

    At Part 1 Week 6; Part 2 Month 3, and Month 6 or at Early Termination, the Investigator rated how much a subject's overall condition had changed since Part 1 Visit 1 (Baseline) using 7-point scale. 1=very much worse and 7=very much improved.


  • Parkinson's Disease Questionnaire-8 (PDQ-8) [ Time Frame: 6 months ]
    Change from Baseline in Parkinson's disease Questionnaire-8 (PDQ-8) at End of Study or early discontinuation. The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).


Enrollment: 43
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPX066
Subjects were to receive individualized IPX066 doses orally in an open-label manner using four dosage strengths.
Drug: IPX066

Subjects were converted from their current treatment to IPX066 over a 6-week period.

Experimental Drug Product: IPX066 (carbidopa-levodopa) extended-release capsules

Other Name: ER CD-LD

Detailed Description:

Part 1: This study was a multicenter, open-label study. Subjects were to be converted from their previous CD-LD treatment to IPX066 over a 6-week period. Up to 40 subjects were to be enrolled in the study. Enrollment was defined as subjects who received study drug in Part 1 - Visit 1. Subjects were to be entered into one of two cohorts.

Approximately 24 subjects were to enroll in Cohort 1 (non-OPDM subjects) and up to 16 subjects at selected sites were to enroll in Cohort 2 (OPDM subjects). For the subjects enrolled in Cohort 2, along with the OPDM measurements, PK blood samples were also to be collected.

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

Part 3: Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study.

  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 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.
  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: NCT01411137

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Coastal Neurological Medical Group
La Jolla, California, United States, 92037
The Parkinson's Institute
Sunnyvale, California, United States, 94085
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Nevada
University of Nevada School of Medicine
Las Vegas, Nevada, United States, 89102
United States, New York
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, United States, 11725
United States, Wisconsin
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Michael J. Fox Foundation for Parkinson's Research
Investigators
Study Chair: Impax Study Director Impax Pharmaceuticals Division (Impax) , a Division of Impax Laboratories Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01411137     History of Changes
Other Study ID Numbers: IPX066-B11-01
Study First Received: August 4, 2011
Results First Received: March 3, 2016
Last Updated: April 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 July 24, 2017