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

NCT01096186 | Completed Phase 3 Results

• 1 other identifier: IPX066-B09-03
• Study Type: interventional
• Target: 617
• Locations: 9 countries
• Sites: 79

Brief Summary

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

Conditions

Parkinson's Disease

Keywords

motor Symptoms; efficacy; IPX066; Parkinson's Disease

Outcome Measures

Primary Outcomes (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

  9 months

Secondary Outcomes (2)

• Total UPDRS Parts I-IV

  9 months

• Patient Global Impression (PGI)

  9 months

Study Arms (1)

Open Label IPX066

OTHER

Subjects 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.

Drug: IPX066 95 mg; Drug: IPX066 145 mg; Drug: IPX066 195 mg; Drug: IPX066 245 mg

Interventions

IPX066 95 mg DRUG

23.75 - 95 mg CD-LD capsules

Also known as: CD-LD ER 95 mg

Open Label IPX066

IPX066 145 mg DRUG

36.25 - 145 mg CD-LD capsules

Also known as: CD-LD ER 145 mg

Open Label IPX066

IPX066 195 mg DRUG

48.75 - 195 mg CD-LD capsules

Also known as: CD-LD ER195 mg

Open Label IPX066

IPX066 245 mg DRUG

61.25 - 245 mg CD-LD capsules

Also known as: CD-LD ER 245 mg

Open Label IPX066

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Impax Laboratories, LLC: lead

Study Sites (81)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Mohammed Ali Parkinson's Center

Phoenix, Arizona, 85013, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Clinical Trials Inc.

Little Rock, Arkansas, 72205, United States

Location

Coastal Neurological Medical Group

La Jolla, California, 92037, United States

Location

Coordinated Clinical Research

La Jolla, California, 92037, United States

Location

The Parkinson's Institute

Sunnyvale, California, 94085, United States

Location

Collaborative NeuroScience Network, Inc.

Torrance, California, 90502, United States

Location

Bradenton Research Center, Inc.

Bradenton, Florida, 34205, United States

Location

Sunrise Clinical Research

Hollywood, Florida, 33021, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

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

Port Charlotte, Florida, 33980, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33713, United States

Location

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

Tampa, Florida, 33603, United States

Location

Medical College of Georgia, Movements Disorders Clinic

Augusta, Georgia, 30912, United States

Location

Movement Disorder Center at Idaho Elks Rehabilitation Hospital

Boise, Idaho, 83702, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Quest Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Struthers Parkinson's Center

Golden Valley, Minnesota, 55427, United States

Location

UMDNJ Robert Wood Johnson Medical Center, Department of Neurology

New Brunswick, New Jersey, 08901, United States

Location

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

Albany, New York, 12208, United States

Location

David L. Kreitzman, MD, P.C.

Commack, New York, 11725, United States

Location

Columbia University Neurological Institute

New York, New York, 10032, United States

Location

Institute for Human Performance

Syracuse, New York, 13210, United States

Location

Duke University Medical Center Movement Disorders Center

Durham, North Carolina, 27707, United States

Location

University Neurology, Inc.

Cincinnati, Ohio, 45219, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9184, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

South Puget Sound Neurology

Tacoma, Washington, 98405, United States

Location

Wisconsin Institute for Neurologic and Sleep Disorders

Milwaukee, Wisconsin, 53233, United States

Location

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Parkinson's & Neurodegenerative Disorder Clinic

Ottawa, Ontario, K1G 4G3, Canada

Location

Ottawa Hospital Civic Site

Ottawa, Ontario, K1Y 4E9, Canada

Location

Quebec Memory & Motor Skills Disorders Clinic

Québec, Quebec, G1R 3X5, Canada

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

West Tallinn Central Hospital,

Tallinn, 10617, Estonia

Location

Praxis für Neurologie und Psychiatrie

Westerstede, Lower Saxony, 26655, Germany

Location

Neurozentrm - Praxis fur Neurologie und Psychiatrie

Berlin, 10437, Germany

Location

Neurologiepraxis

Berlin, 12163, Germany

Location

P.Stradina university hospital

Riga, 1002, Latvia

Location

Gailezers hospital

Riga, Latvia

Location

Kaunas Medical University Hospital

Kaunas, LT-50009, Lithuania

Location

Siauliai Regional Hospital

Šiauliai, LT-76231, Lithuania

Location

National Centre of Osteoporosis

Vilnius, LT-01102, Lithuania

Location

Vilnius University Emergency Hospital

Vilnius, LT-04130, Lithuania

Location

Vilnius University Hospital Santariskiu klinikos

Vilnius, LT-08661, Lithuania

Location

PALLMED Sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Krakowska Akademia Neurologii Sp. z o. o.

Krakow, Lesser Poland Voivodeship, 31-530, Poland

Location

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

Lublin, Lublin Voivodeship, 20-718, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-777, Poland

Location

Euromedis Sp. z o.o.

Szczecin, West Pomeranian Voivodeship, 70-215, Poland

Location

Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska

Mosina, Wielkopoloskie, 62-050, Poland

Location

Neuro-Care NZOZ

Katowice, 40-546, Poland

Location

Clinical Rehabilitation Hospital Iasi, Neurology Department

Lasi, Romania, 700661, Romania

Location

Psychiatry and Neurology Hospital Brasov, Neurology Department

Brasov, 500123, Romania

Location

Neomed Research

Brasov, 500283, Romania

Location

Colentina Clinical Hospital Bucharest, II Neurology Department

Bucharest, 020125, Romania

Location

CFR Clinical Hospital Constanta, Neurology Department

Constanța, 900123, Romania

Location

County Clinical Emergency Hospital Targu Mures, I Neurology Department

Târgu Mureş, 540136, Romania

Location

County Clinical Emergency Hospital Targu Mures, II Neurology Department

Târgu Mureş, 540136, Romania

Location

County Clinical Emergency Hospital Timisoara, Neurology Department

Timișoara, 300736, Romania

Location

Hospital General de Cataluña

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Clinica Ruber SA

Madrid, 28006, Spain

Location

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

Dnipropetrovsk, 49005, Ukraine

Location

Department of Psychiatry and Medical Psychology of Donetsk National Medical University

Donetsk, 83037, Ukraine

Location

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

Donetsk, 83099, Ukraine

Location

1st neurology department of Central Clinical Hospital of Ukrzaliznytsya

Kharkiv, 61058, Ukraine

Location

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

Kharkiv, 61068, Ukraine

Location

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

Kharkiv, 61068, Ukraine

Location

Neurology department of Lviv regional clinical hospital

Lviv, 79010, Ukraine

Location

Odessa Regional Clinical Hospital, Dept. of Neurosurgery

Odesa, 65025, Ukraine

Location

Neurology department of Medical Dental Academy based on Poltava regional hospital

Poltava, 36000, Ukraine

Location

Vinnytsia Regional Psycho-Neurological Hospital

Vinnytsia, 21005, Ukraine

Location

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

Zaporizhzhya, 69035, Ukraine

Location

Zaporozhye Regional Clinical Hospital

Zaporizhzhya, 69600, Ukraine

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Daven Mody, PharmD, MBA, Director, Regulatory Affairs
• Organization: Impax Laboratories, Inc.

dmody@impaxlabs.com

510-240-6073

Study Officials

• Impax Study Director

  Impax Laboratories, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 31, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 8, 2019
• Results First Posted: March 3, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); RO (8); LI (5); CA (4); LA (2); PL (7); ES (2); US (36); UA (12)