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Parkinson's DiseasePhase 3NCT01130493

A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066

A Phase 3 study testing IPX066 and CLE in people with Parkinson's Disease, run by Impax Laboratories, LLC at 24 sites in 4 countries.

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

This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease. 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 and CLE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
24 sitesin 4 countries
Study dates
May 2010to Jan 2012
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 Parkinson's Disease (PD).
  • At least 30 years old at the time of PD diagnosis.
  • Currently being treated with carbidopa/levodopa/entacapone (CLE) and on a stable regimen of conventional LD for at least 4 weeks and:
  • Requiring a total daily levodopa (LD) dose of at least 400 mg
  • Having a minimum dosing frequency of four times per day.
  • Individual CD-LD or CLE doses that contain an LD dose which is a multiple of 50 mg.
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  • Able to differentiate "on" state from "off" state.
  • Have predictable "off" periods.
  • Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are 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 afterward.

Who cannot join

  • 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.
  • Received within 4 weeks of Screening or planning to take during participation in the clinical study: any controlled-release LD product, tolcapone, apomorphine, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
  • Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
  • History of or currently active psychosis.
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  • Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
  • 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 or nontraumatic rhabdomyolysis.
  • Received any investigational medications during the 4 weeks prior to Screening.
  • Unable to swallow large pills (e.g., large vitamin pills).
  • Pregnant or breastfeeding.
  • Subjects who are unable to complete a symptom diary.

Trial locations and contacts

24 sites in 4 countries.

24 sites in 4 countries

United States12 sites

  • Quest Research Institute

    Bingham Farms, Michigan, 48025

  • University Neurology, Inc

    Cincinnati, Ohio, 45219

  • Parkinson's Disease and Movement Disorders Center of Long Island

    Commack, New York, 11725

  • Margolin Brain Institute

    Fresno, California, 93720

  • Kingston Neurological Associates

    Kingston, New York, 12401

  • Booth Gardner Parkinson's Care Center

    Kirkland, Washington, 98034

  • University Health Systems

    Las Vegas, Nevada, 89102

  • UM Movement Disorders Center

    Miami, Florida, 33136

  • Charlotte Neurological Services

    Port Charlotte, Florida, 33980

  • The Parkinson's Institute in Sunnyvale

    Sunnyvale, California, 94085

  • USF Parkinson's and Movement Disorders Center

    Tampa, Florida, 33606

  • Sentara Neurological Associates

    Virginia Beach, Virginia, 23456

Other trials in United States

Germany5 sites

  • Praxis für Neurologie, Psychiatrie und Psychotherapie Achim

    Achim, 28832

  • Praxis Dres. Bitter/Schumann

    Bochum, 44805

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Klinik für Neurologie, Stadtroda

    Stadtroda, 07646

  • RKU, Neurologische Klinik der Universität Ulm

    Ulm, 89081

Other trials in Germany

Italy5 sites

  • Casa di Cura Villa Margherita

    Arcugnano, 36057

  • San Raffaele Cassino, San Raffaele Cassino,

    Cassino, 03043

  • Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio

    Chieti, 66013

  • Ospedale della Misericordia

    Grosseto, 58100

  • IRCCS San Raffaele Pisana

    Roma, 163

Other trials in Italy

France2 sites

  • Hôpital Gabriel Montpied-Service de Neurologie A-

    Clermont-Ferrand, 63003

  • Service de neurologie-Hôpital de la Timone-

    Marseille, 13385

Other trials in France

About this study

Official title: A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease

This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.

Read the detailed description

This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.

Being tested
IPX066, CLE
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 extended-release carbidopa-levodopa

    experimental product

  • CLEDrug

    Also called carbidopa/levodopa/entacapone

    active comparator

Study groups in NCT01130493
Study groupRoleWhat they receive
IPX066-CLE-OLEOtherDose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2)
Receives: Drug: IPX066; Drug: CLE
CLE-IPX066-OLEOtherDose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)
Receives: Drug: IPX066; Drug: CLE

What is being measured

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

  1. Percentage of "OFF" Time During Waking Hours

    Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.

    Mean percentage of "OFF" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.

    Measured: 3 days of data immediately prior to the end of each 2 week treatment period

Secondary outcomes (4)

  1. Total "OFF" Time During Waking Hours

    Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.

    Mean Total "Off" Time During Waking Hours was calculated. "Off" Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.

    Measured: 3 days of data immediately prior to the end of each 2 week treatment period

  2. Total "On" With No Troublesome Dyskinesia

    Using a Parkinson's disease diary, subjects recorded a state of "asleep", "OFF", "ON without dyskinesia," "ON with non-troublesome dyskinesia," or "ON with troublesome dyskinesia" every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.

    Mean Total "On" with No Troublesome Dyskinesia was calculated. "On" Time is when medication is providing benefit with regard to mobility, slowness, and stiffness.

    Measured: 3 days of data immediately prior to the end of each 2 week treatment period

  3. UPDRS Part II Plus Part III

    Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108.

    The UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility.

    Measured: End of each double-blind treatment period.

  4. Subject Preference

    Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.

    Measured: End of Study (week 11)

Timeline

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

  1. First posted26 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

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
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130493
Sponsor's protocol ID
IPX066-B09-06
Status last verified
Sep 2017
First submitted
24 May 2010
Last updated
29 Oct 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018.

    PubMed 30425824

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IPX066 and CLE in people with Parkinson's Disease, run by Impax Laboratories, LLC at 24 sites in 4 countries.

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 10 inclusion and 14 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 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Germany, Italy, France. 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 13 Sep 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?

Percentage of "OFF" Time During Waking Hours (time frame: 3 days of data immediately prior to the end of each 2 week treatment period). 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 NCT01130493, 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 29 Oct 2019.

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