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Parkinson's DiseasePhase 3NCT00974974

A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

A Phase 3 study testing IPX066 and IR CD-LD in people with Parkinson's Disease, run by Impax Laboratories, LLC at 73 sites in 8 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a study to evaluate the safety and efficacy of IPX066 in 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 IR CD-LD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
471 participants
Where
73 sitesin 8 countries
Study dates
Sep 2009to Mar 2011
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.
  • At least 30 years old at the time of PD diagnosis.
  • Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:
  • Requiring a total daily IR LD dose of at least 400 mg
  • Having a minimum dosing frequency of four times per day.
  • Able to differentiate "on" state from "off" state.
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  • 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 or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
  • Allergic to Yellow Dye #5 (tartrazine).
  • 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.
  • A 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.
  • 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

73 sites in 8 countries.

73 sites in 8 countries

United States35 sites

  • Investigator 25

    Albany, New York, 12208

  • Investigator 46

    Augusta, Georgia, 30912

  • Investigator 51

    Aurora, Colorado, 80045

  • Investigator 1

    Bingham Farms, Michigan, 48025

  • Investigator 17

    Birmingham, Alabama, 35233

  • Investigator 38

    Boise, Idaho, 83702

  • Investigator 64

    Bradenton, Florida, 34205

  • Investigator 14

    Charleston, South Carolina, 29401

  • Investigator 19

    Chicago, Illinois, 60611

  • Investigator 40

    Chicago, Illinois, 60612

  • Investigator 20

    Cincinnati, Ohio, 45219

  • Investigator 8

    Commack, New York, 11725

  • Investigator 16

    Dallas, Texas, 75390-9016

  • Investigator 39

    Des Moines, Iowa, 50309

  • Investigator 11

    Durham, North Carolina, 27707

  • Investigator 61

    Hollywood, Florida, 33021

  • Investigator 13

    Houston, Texas, 77030-2744

  • Investigator 29

    Kansas City, Kansas, 66160

  • Investigator 3

    La Jolla, California, 92037

  • Investigator 7

    Little Rock, Arkansas, 72205

  • Investigator 2

    Milwaukee, Wisconsin, 53233

  • Investigator 21

    New Brunswick, New Jersey, 08901

  • Investigator 10

    New Haven, Connecticut, 06510

  • Investigator 12

    New York, New York, 10032

  • Investigator 5

    Ocala, Florida, 34471

  • Investigator 49

    Phoenix, Arizona, 85013

  • Investigator 15

    Port Charlotte, Florida, 33980

  • Investigator 8

    Port Charlotte, Florida, 33980

  • Investigator 9

    Raleigh, North Carolina, 27607

  • Investigator 4

    St. Petersburg, Florida, 33713

  • Investigator 31

    Sunnyvale, California, 94085

  • Investigator 65

    Tacoma, Washington, 98405

  • Investigator 42

    Toledo, Ohio, 43614

  • Investigator 6

    Torrance, California, 90502

  • Investigator 60

    Tulsa, Oklahoma, 74137

Other trials in United States

Poland7 sites

  • Investigator 48

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Investigator 34

    Katowice, 40-546

  • Investigator 37

    Krakow, Lesser Poland Voivodeship, 31-530

  • Investigator 59

    Lublin, Lublin Voivodeship, 20-718

  • Investigator 35

    Mosina, Wielkopoloskie, 62-050

  • Investigator 54

    Szczecin, West Pomeranian Voivodeship, 70-215

  • Investigator 36

    Warsaw, Masovian Voivodeship, 02-777

Other trials in Poland

Ukraine7 sites

  • Investigator 55

    Dnipro, Dnipropetrovsk Oblast, 49005

  • Investigator 71

    Donetsk, 83003

  • Investigator 44

    Kharkiv, 61068

  • Investigator 66

    Odesa, 65117

  • Investigator 56

    Vinnitsa, Vinnytsya, 21005

  • Investigator 47

    Zaporizhzhya, Zaporizhzhya, 69600

  • Investigator 41

    Zaporizhzhya, 69035

Other trials in Ukraine

Germany6 sites

  • Investigator 23

    Berlin, 10437

  • Investigator 72

    Berlin, 12163

  • Investigator 28

    Berlin, 13088

  • Investigator 67

    Berlin, 13353

  • Investigator 30

    Sachsen, Dresden, 1307

  • Investigator 27

    Westerstede, Lower Saxony, 26655

Other trials in Germany

Spain6 sites

  • Investigator 70

    Barcelona, 8028

  • Investigator 57

    Barcelona, 8036

  • Investigator 45

    Barcelona, 8190

  • Investigator 50

    Madrid, 28006

  • Investigator 53

    Madrid, 28922

  • Investigator 43

    Terrassa, Barcelona, 8221

Other trials in Spain

France5 sites

  • Investigator 22

    Dijon, Bourgogne-Franche-Comté, 21000

  • Investigator 52

    Lille, Hauts-de-France, 59037

  • Investigator 58

    Paris, Île-de-France Region, 75013

  • Investigator 32

    Strasbourg, Alsace, 67091

  • Investigator 33

    Toulouse, Midi-pyrenees, 31059

Other trials in France

Romania4 sites

  • Investigator 68

    Brasov, 500283

  • Investigator 62

    Bucharest, 20125

  • Investigator 69

    Târgu Mureş, Mureș County, 540136

  • Investigator 63

    Târgu Mureş, 540136

Other trials in Romania

Canada3 sites

  • Investigator 24

    London, Ontario, N6A 5A5

  • Investigator 18

    Ottawa, Ontario, K1G 4G3

  • Investigator 26

    Québec, Quebec, G1R 3X5

Other trials in Canada

About this study

Official title: A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease

This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

Read the detailed description

A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.

Being tested
IPX066, IR CD-LD
Keywords
Parkinson's Disease
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

    extended-release carbidopa-levodopa capsules

  • IR CD-LDDrug

    Also called immediate-release carbidopa-levodopa

    immediate-release carbidopa-levodopa tablets

Study groups in NCT00974974
Study groupRoleWhat they receive
IPX066ExperimentalFollowing IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
Receives: Drug: IPX066; Drug: IR CD-LD
IR CD-LDActive comparatorFollowing IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
Receives: Drug: IPX066; Drug: IR CD-LD

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 at End of Study

    Percentage of "off" time during waking hours at end of study is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."

    Measured: 22 weeks

Secondary outcomes (2)

  1. "Off" Time

    "Off" time hours is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."

    Measured: 22 weeks

  2. "On" Time Without Troublesome Dyskinesia

    "On" time without troublesome dyskinesiais measured by using the Parkinson's disease diary. "On" time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living."

    Measured: 22 weeks

Timeline

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

  1. First posted11 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJan 2011
  4. Study completionMar 2011

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974974
Sponsor's protocol ID
IPX066-B09-02
Status last verified
Jan 2017
First submitted
10 Sep 2009
Last updated
11 Aug 2020
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

  • Hauser RA, Hsu A, Kell S, Espay AJ, Sethi K, Stacy M, Ondo W, O'Connell M, Gupta S; IPX066 ADVANCE-PD investigators. Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: a phase 3 randomised, double-blind trial. Lancet Neurol. 2013 Apr;12(4):346-56. doi: 10.1016/S1474-4422(13)70025-5. Epub 2013 Feb 26.

    PubMed 23485610

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IPX066 and IR CD-LD in people with Parkinson's Disease, run by Impax Laboratories, LLC at 73 sites in 8 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 9 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 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Poland, Ukraine, Germany, Spain and 3 more countries. 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 14 Jan 2016). 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 at End of Study (time frame: 22 weeks). 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 NCT00974974, which also lists 2 linked publications.

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 11 Aug 2020.

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