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

NCT01411137 | Completed Phase 3 Results

• 1 other identifier: IPX066-B11-01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (3)

• Patient Global Impression (PGI)

  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.

  6 months

• Clinical Global Impression (CGI)

  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.

  6 months

• Parkinson's Disease Questionnaire-8 (PDQ-8)

  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).

  6 months

Study Arms (1)

IPX066

EXPERIMENTAL

Subjects were to receive individualized IPX066 doses orally in an open-label manner using four dosage strengths.

Drug: IPX066

Interventions

IPX066 DRUG

Subjects were converted from their current treatment to IPX066 over a 6-week period. Experimental Drug Product: IPX066 (carbidopa-levodopa) extended-release capsules

Also known as: ER CD-LD

IPX066

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with idiopathic PD without any known cause for Parkinsonism.
• At least 30 years old at the time of PD diagnosis.
• 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
• 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.
• Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.

You may not qualify if:

• Pregnant or breastfeeding
• Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
• Nonresponsive to LD therapy.
• Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
• 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.
• Any evidence of suicidal behavior within 6 months of entering the study.
• Allergic or hypersensitive to to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
• History of or currently active psychosis.
• Active or history of peptic ulcers or surgical procedure of the stomach, the small intestine or the large intestine.
• Active or history of narrow-angle glaucoma.
• History of malignant melanoma or a suspicious undiagnosed skin lesion.
• History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
• Abnormal kidney function
• Severe hepatic impairment.
• Received any investigational medications during the 4 weeks prior to Screening.

Sponsors & Collaborators

• Impax Laboratories, LLC: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Coastal Neurological Medical Group

La Jolla, California, 92037, United States

Location

The Parkinson's Institute

Sunnyvale, California, 94085, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Quest Research Institute

Bingham Farms, Michigan, 48025, United States

Location

University of Nevada School of Medicine

Las Vegas, Nevada, 89102, United States

Location

Parkinson's Disease and Movement Disorders Center of Long Island

Commack, New York, 11725, United States

Location

Wisconsin Institute for Neurologic and Sleep Disorders

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (1)

• Tetrud J, Nausieda P, Kreitzman D, Liang GS, Nieves A, Duker AP, Hauser RA, Farbman ES, Ellenbogen A, Hsu A, Kell S, Khanna S, Rubens R, Gupta S. Conversion to carbidopa and levodopa extended-release (IPX066) followed by its extended use in patients previously taking controlled-release carbidopa-levodopa for advanced Parkinson's disease. J Neurol Sci. 2017 Feb 15;373:116-123. doi: 10.1016/j.jns.2016.11.047. Epub 2016 Nov 23.

  PMID: 28131167 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Michelle Landolfi, Senior Director, Regulatory Affairs
• Organization: Impax Laboratories, Inc.

Michelle.Landolfi@impaxlabs.com

(510) 240-6496

Study Officials

• Impax Study Director

  Impax Laboratories, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 8, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 7, 2019
• Results First Posted: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)