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Parkinson's DiseasePhase 3NCT01096186

An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

A Phase 3 study testing IPX066 95 mg, IPX066 145 mg and IPX066 195 mg in people with Parkinson's Disease, run by Impax Laboratories, LLC at 81 sites in 10 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

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with 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 95 mg, IPX066 145 mg and IPX066 195 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
617 participants
Where
81 sitesin 10 countries
Study dates
Mar 2010to Oct 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

  • Each subject must meet the following inclusion criteria in order to be enrolled in the study:
  • Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.
  • In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.

Who cannot join

  • Each subject must be free of the following exclusion criteria in order to be enrolled in the study:
  • Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
  • Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
  • Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).
  • In the opinion of the Investigator, should not participate in the study.

Trial locations and contacts

81 sites in 10 countries.

81 sites in 10 countries

United States36 sites

  • Albany Medical College, Parkinson's Disease and Movement Disorders Center

    Albany, New York, 12208

  • Medical College of Georgia, Movements Disorders Clinic

    Augusta, Georgia, 30912

  • Quest Research Institute

    Bingham Farms, Michigan, 48025

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Movement Disorder Center at Idaho Elks Rehabilitation Hospital

    Boise, Idaho, 83702

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205

  • Medical University of South Carolina

    Charleston, South Carolina, 29401

  • Northwestern University, Feinberg School of Medicine, Dept. of Neurology

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Neurology, Inc.

    Cincinnati, Ohio, 45219

  • David L. Kreitzman, MD, P.C.

    Commack, New York, 11725

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9184

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Duke University Medical Center Movement Disorders Center

    Durham, North Carolina, 27707

  • Struthers Parkinson's Center

    Golden Valley, Minnesota, 55427

  • Sunrise Clinical Research

    Hollywood, Florida, 33021

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Coastal Neurological Medical Group

    La Jolla, California, 92037

  • Coordinated Clinical Research

    La Jolla, California, 92037

  • Clinical Trials Inc.

    Little Rock, Arkansas, 72205

  • Wisconsin Institute for Neurologic and Sleep Disorders

    Milwaukee, Wisconsin, 53233

  • UMDNJ Robert Wood Johnson Medical Center, Department of Neurology

    New Brunswick, New Jersey, 08901

  • Columbia University Neurological Institute

    New York, New York, 10032

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Mohammed Ali Parkinson's Center

    Phoenix, Arizona, 85013

  • HOPE Research Institute

    Phoenix, Arizona, 85050

  • Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida

    Port Charlotte, Florida, 33980

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33713

  • The Parkinson's Institute

    Sunnyvale, California, 94085

  • Institute for Human Performance

    Syracuse, New York, 13210

  • South Puget Sound Neurology

    Tacoma, Washington, 98405

  • University of South Florida, Parkinson's Disease and Movement Disorders Center

    Tampa, Florida, 33603

  • University of Toledo

    Toledo, Ohio, 43614

  • Collaborative NeuroScience Network, Inc.

    Torrance, California, 90502

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

Other trials in United States

Ukraine12 sites

  • Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk regional hospital named after Mechnikov

    Dnipropetrovsk, 49005

  • Department of Psychiatry and Medical Psychology of Donetsk National Medical University

    Donetsk, 83037

  • Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University

    Donetsk, 83099

  • 1st neurology department of Central Clinical Hospital of Ukrzaliznytsya

    Kharkiv, 61058

  • Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine

    Kharkiv, 61068

  • Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine

    Kharkiv, 61068

  • Neurology department of Lviv regional clinical hospital

    Lviv, 79010

  • Odessa Regional Clinical Hospital, Dept. of Neurosurgery

    Odesa, 65025

  • Neurology department of Medical Dental Academy based on Poltava regional hospital

    Poltava, 36000

  • Vinnytsia Regional Psycho-Neurological Hospital

    Vinnytsia, 21005

  • Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6

    Zaporizhzhya, 69035

  • Zaporozhye Regional Clinical Hospital

    Zaporizhzhya, 69600

Other trials in Ukraine

Romania8 sites

  • Psychiatry and Neurology Hospital Brasov, Neurology Department

    Brasov, 500123

  • Neomed Research

    Brasov, 500283

  • Colentina Clinical Hospital Bucharest, II Neurology Department

    Bucharest, 020125

  • CFR Clinical Hospital Constanta, Neurology Department

    Constanța, 900123

  • Clinical Rehabilitation Hospital Iasi, Neurology Department

    Lasi, Romania, 700661

  • County Clinical Emergency Hospital Targu Mures, I Neurology Department

    Târgu Mureş, 540136

  • County Clinical Emergency Hospital Targu Mures, II Neurology Department

    Târgu Mureş, 540136

  • County Clinical Emergency Hospital Timisoara, Neurology Department

    Timișoara, 300736

Other trials in Romania

Poland7 sites

  • PALLMED Sp. z o.o.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Neuro-Care NZOZ

    Katowice, 40-546

  • Krakowska Akademia Neurologii Sp. z o. o.

    Krakow, Lesser Poland Voivodeship, 31-530

  • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie

    Lublin, Lublin Voivodeship, 20-718

  • Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska

    Mosina, Wielkopoloskie, 62-050

  • Euromedis Sp. z o.o.

    Szczecin, West Pomeranian Voivodeship, 70-215

  • Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.

    Warsaw, Masovian Voivodeship, 02-777

Other trials in Poland

Lithuania5 sites

  • Kaunas Medical University Hospital

    Kaunas, LT-50009

  • Siauliai Regional Hospital

    Šiauliai, LT-76231

  • National Centre of Osteoporosis

    Vilnius, LT-01102

  • Vilnius University Emergency Hospital

    Vilnius, LT-04130

  • Vilnius University Hospital Santariskiu klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Canada4 sites

  • London Health Sciences Centre, University Hospital

    London, Ontario, N6A 5A5

  • Parkinson's & Neurodegenerative Disorder Clinic

    Ottawa, Ontario, K1G 4G3

  • Ottawa Hospital Civic Site

    Ottawa, Ontario, K1Y 4E9

  • Quebec Memory & Motor Skills Disorders Clinic

    Québec, Quebec, G1R 3X5

Other trials in Canada

Germany3 sites

  • Neurozentrm - Praxis fur Neurologie und Psychiatrie

    Berlin, 10437

  • Neurologiepraxis

    Berlin, 12163

  • Praxis für Neurologie und Psychiatrie

    Westerstede, Lower Saxony, 26655

Other trials in Germany

Estonia2 sites

  • East Tallinn Central Hospital

    Tallinn, 10138

  • West Tallinn Central Hospital,

    Tallinn, 10617

Other trials in Estonia

Latvia2 sites

  • P.Stradina university hospital

    Riga, 1002

  • Gailezers hospital

    Riga

Other trials in Latvia

Spain2 sites

  • Clinica Ruber SA

    Madrid, 28006

  • Hospital General de Cataluña

    Sant Cugat del Vallès, Barcelona, 08195

Other trials in Spain

About this study

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

Read the detailed description

IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066:

  • IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease)
  • IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa - Levodopa)
  • IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease)

All participants will be given IPX066 for 9 months.

Being tested
IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, IPX066 245 mg
Keywords
motor Symptoms, efficacy, IPX066, 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.

  • IPX066 95 mgDrug

    Also called CD-LD ER 95 mg

    23.75 - 95 mg CD-LD capsules

  • IPX066 145 mgDrug

    Also called CD-LD ER 145 mg

    36.25 - 145 mg CD-LD capsules

  • IPX066 195 mgDrug

    Also called CD-LD ER195 mg

    48.75 - 195 mg CD-LD capsules

  • IPX066 245 mgDrug

    Also called CD-LD ER 245 mg

    61.25 - 245 mg CD-LD capsules

Study groups in NCT01096186
Study groupRoleWhat they receive
Open Label IPX066OtherSubjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.
Receives: Drug: IPX066 95 mg; Drug: IPX066 145 mg; Drug: IPX066 195 mg; Drug: IPX066 245 mg

What is being measured

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

  1. Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III

    Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study.

    Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.

    Subscales II and III were summed:

    Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25

    Measured: 9 months

Secondary outcomes (2)

  1. Total UPDRS Parts I-IV

    Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient.

    Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome.

    Subscales II and III were summed:

    Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25

    Measured: 9 months

  2. Patient Global Impression (PGI)

    Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale.

    Patient Global Impression 0-7 - higher value indicates increased improvement from study start

    Measured: 9 months

Timeline

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

  1. First posted31 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionOct 2011
  4. Study completionOct 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
617 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01096186
Sponsor's protocol ID
IPX066-B09-03
Status last verified
Jan 2017
First submitted
25 Mar 2010
Last updated
8 Nov 2019
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IPX066 95 mg, IPX066 145 mg and IPX066 195 mg in people with Parkinson's Disease, run by Impax Laboratories, LLC at 81 sites in 10 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 3 inclusion and 5 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 8 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 81 sites in United States, Ukraine, Romania, Poland, Lithuania and 5 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 3 Mar 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?

Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III (time frame: 9 months). 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 NCT01096186.

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 8 Nov 2019.

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