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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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

IPX066

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Previously enrolled in IPX066 studies.

Sites / Locations

University of Alabama at Birmingham
Coastal Neurological Medical Group
The Parkinson's Institute
Renstar Medical Research
Quest Research Institute
University of Nevada School of Medicine
Parkinson's Disease and Movement Disorders Center of Long Island
Wisconsin Institute for Neurologic and Sleep Disorders

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IPX066

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01411137

First Posted

August 4, 2011

Last Updated

October 25, 2019

Sponsor

Impax Laboratories, LLC

Collaborators

Michael J. Fox Foundation for Parkinson's Research

1. Study Identification

Unique Protocol Identification Number

NCT01411137

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Impax Laboratories, LLC

Collaborators

Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IPX066

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

IPX066

Other Intervention Name(s)

ER CD-LD

Intervention Description

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

Primary Outcome Measure Information:

Title

Patient Global Impression (PGI)

Description

Time Frame

6 months

Title

Clinical Global Impression (CGI)

Description

Time Frame

6 months

Title

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

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Previously enrolled in IPX066 studies.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Impax Study Director

Organizational Affiliation

Impax Laboratories, LLC

Official's Role

Study Chair

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Coastal Neurological Medical Group

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

The Parkinson's Institute

City

Sunnyvale

State/Province

California

ZIP/Postal Code

94085

Country

United States

Facility Name

Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Quest Research Institute

City

Bingham Farms

State/Province

Michigan

ZIP/Postal Code

48025

Country

United States

Facility Name

University of Nevada School of Medicine

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

Parkinson's Disease and Movement Disorders Center of Long Island

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Facility Name

Wisconsin Institute for Neurologic and Sleep Disorders

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53233

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28131167

Citation

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.

Results Reference

derived

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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

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