Parkinson's DiseasePhase 3NCT01411137

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

A Phase 3 study testing IPX066 in people with Parkinson's Disease, run by Impax Laboratories, LLC at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: IPX066
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 8 sitesUnited States
Study dates: Aug 2011to Mar 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Quest Research Institute
Bingham Farms, Michigan, 48025
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, 11725
Coastal Neurological Medical Group
La Jolla, California, 92037
University of Nevada School of Medicine
Las Vegas, Nevada, 89102
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, 53233
Renstar Medical Research
Ocala, Florida, 34471
The Parkinson's Institute
Sunnyvale, California, 94085

Other trials in United States

About this 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

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.

Read the 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.

Conditions: Parkinson's Disease
Being tested: IPX066
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IPX066Drug
Also called ER CD-LD
Subjects were converted from their current treatment to IPX066 over a 6-week period.
Experimental Drug Product: IPX066 (carbidopa-levodopa) extended-release capsules

Study groups in NCT01411137
Study group	Role	What they receive
IPX066	Experimental	Subjects were to receive individualized IPX066 doses orally in an open-label manner using four dosage strengths. Receives: Drug: IPX066

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Mar 2013

First posted8 Aug 2011 (estimated)
Study startAug 2011
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01411137
Sponsor's protocol ID: IPX066-B11-01
Status last verified: Apr 2017
First submitted: 4 Aug 2011
Last updated: 7 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 28131167

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01411137
Acronym / sponsor ID: IPX066-B11-01
Conditions: Parkinson's Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Impax Laboratories, LLCIndustry (pharma, biotech, devices)
Collaborators: Michael J. Fox Foundation for Parkinson's Research
Study start: Aug 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 8 Aug 2011 (estimated)
Results: Posted 18 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IPX066	Experimental	Drug: IPX066Subjects were to receive individualized IPX066 doses orally in an open-label manner using four dosage strengths.

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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:
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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IPX066Also: ER CD-LDSubjects were converted from their current treatment to IPX066 over a 6-week period. Experimental Drug Product: IPX066 (carbidopa-levodopa) extended-release capsules	Drug	IPX066

Primary outcome

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).

Results and safety

Results posted to the registry on 18 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IPX066	43	33

Primary outcome: Patient Global Impression (PGI)

Time frame: 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Part 1: Conversion n = 33	Part 2: Open-Label Extension (Month 3) n = 26	Part 2: Open-Label Extension (Month 6) n = 25	Part 1 or 2 Early Termination n = 15
Value	5.2 (1.35)	5.4 (1.30)	5.3 (1.49)	2.8 (1.21)

Primary outcome: Clinical Global Impression (CGI)

Time frame: 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Part 1: Conversion n = 33	Part 2: Open-Label Extension (Month 3) n = 26	Part 2: Open-Label Extension (Month 6) n = 25	Part 1 or 2 Early Termination n = 15
Value	5.5 (1.15)	5.7 (1.08)	5.6 (1.39)	3.7 (0.80)

Primary outcome: Parkinson's Disease Questionnaire-8 (PDQ-8)

Time frame: 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Part 1: Conversion (Baseline) n = 43	Part 1: Conversion (Week 6) n = 33	Part 2: Open-Label Extension (Month 3) n = 26	Part 2: Open-Label Extension (Month 6) n = 25	Part 1 or 2 Early Termination n = 15
Value	9.6 (5.49)	8.1 (4.62)	8.5 (4.79)	9.0 (5.91)	11.8 (6.62)

Adverse events

Time frame: 58 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Conversion	1 of 43 (2.3%)	18 of 43 (41.9%)	Not reported
Part 2: Open-Label Extension 1	5 of 32 (15.6%)	17 of 32 (53.1%)	Not reported
Part 3: Open-Label Extension 2	3 of 12 (25%)	9 of 12 (75%)	Not reported
Overall	9 of 43 (20.9%)	35 of 43 (81.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28131167Tetrud 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Impax Study Director study chair

Impax Laboratories, LLC

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IPX066 in people with Parkinson's Disease, run by Impax Laboratories, LLC at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Global Impression (PGI) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01411137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.