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

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: IPX066 95 mg; Drug: IPX066 145 mg; Drug: IPX066 195 mg; Drug: IPX066 245 mg

• Registration Number: NCT01096186
• Lead Sponsor: Impax Laboratories, LLC

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.

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2013-09-27
• Disposition First Submitted QC: 2013-09-27
• Disposition First Posted: 2013-10-28
• Results First Submitted: 2015-12-09
• Results First Submitted QC: 2016-02-04
• Results First Posted: 2016-03-03
• Status Verified: 2017-01
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 617

Inclusion Criteria

• Each subject must meet the following inclusion criteria in order to be enrolled in the study:

  1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.
  2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.

Exclusion Criteria

• Each subject must be free of the following exclusion criteria in order to be enrolled in the study:

  1. Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
  2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
  3. 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).
  4. In the opinion of the Investigator, should not participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label IPX066	IPX066 145 mg	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.
Open Label IPX066	IPX066 95 mg	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.
Open Label IPX066	IPX066 245 mg	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.
Open Label IPX066	IPX066 195 mg	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III	9 months	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

Secondary Outcome Measures

Name	Time	Method
Total UPDRS Parts I-IV	9 months	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
Patient Global Impression (PGI)	9 months	Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale.; Patient Global Impression 0-7 - higher value indicates increased improvement from study start

Trial Locations

Locations (81)

Coastal Neurological Medical Group; 🇺🇸 La Jolla, California, United States

The Parkinson's Institute; 🇺🇸 Sunnyvale, California, United States

Coordinated Clinical Research; 🇺🇸 La Jolla, California, United States

Collaborative NeuroScience Network, Inc.; 🇺🇸 Torrance, California, United States

Bradenton Research Center, Inc.; 🇺🇸 Bradenton, Florida, United States

Sunrise Clinical Research; 🇺🇸 Hollywood, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Suncoast Neuroscience Associates, Inc.; 🇺🇸 Saint Petersburg, Florida, United States

Medical College of Georgia, Movements Disorders Clinic; 🇺🇸 Augusta, Georgia, United States

Movement Disorder Center at Idaho Elks Rehabilitation Hospital; 🇺🇸 Boise, Idaho, United States

Northwestern University, Feinberg School of Medicine, Dept. of Neurology; 🇺🇸 Chicago, Illinois, United States

Iowa Methodist Medical Center; 🇺🇸 Des Moines, Iowa, United States

Quest Research Institute; 🇺🇸 Bingham Farms, Michigan, United States

Struthers Parkinson's Center; 🇺🇸 Golden Valley, Minnesota, United States

Albany Medical College, Parkinson's Disease and Movement Disorders Center; 🇺🇸 Albany, New York, United States

David L. Kreitzman, MD, P.C.; 🇺🇸 Commack, New York, United States

Columbia University Neurological Institute; 🇺🇸 New York, New York, United States

Institute for Human Performance; 🇺🇸 Syracuse, New York, United States

The Movement Disorder Clinic of Oklahoma; 🇺🇸 Tulsa, Oklahoma, United States

University of Toledo; 🇺🇸 Toledo, Ohio, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

South Puget Sound Neurology; 🇺🇸 Tacoma, Washington, United States

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada

Parkinson's & Neurodegenerative Disorder Clinic; 🇨🇦 Ottawa, Ontario, Canada

Ottawa Hospital Civic Site; 🇨🇦 Ottawa, Ontario, Canada

Quebec Memory & Motor Skills Disorders Clinic; 🇨🇦 Quebec, Canada

Neurozentrm - Praxis fur Neurologie und Psychiatrie; 🇩🇪 Berlin, Germany

Praxis für Neurologie und Psychiatrie; 🇩🇪 Westerstede, Niedersachsen, Germany

Neurologiepraxis; 🇩🇪 Berlin, Germany

Hospital General de Cataluña; 🇪🇸 Sant Cugat Del Valles, Barcelona, Spain

Clinica Ruber SA; 🇪🇸 Madrid, Spain

Neurology department of Medical Dental Academy based on Poltava regional hospital; 🇺🇦 Poltava,, Ukraine

Vinnytsia Regional Psycho-Neurological Hospital; 🇺🇦 Vinnytsia, Ukraine

Zaporozhye Regional Clinical Hospital; 🇺🇦 Zaporozhye, Ukraine

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Clinical Trials Inc.; 🇺🇸 Little Rock, Arkansas, United States

Gailezers hospital; 🇱🇻 Riga, Latvia

Kaunas Medical University Hospital; 🇱🇹 Kaunas, Lithuania

Siauliai Regional Hospital; 🇱🇹 Siauliai, Lithuania

National Centre of Osteoporosis; 🇱🇹 Vilnius, Lithuania

Vilnius University Hospital Santariskiu klinikos; 🇱🇹 Vilnius, Lithuania

UMDNJ Robert Wood Johnson Medical Center, Department of Neurology; 🇺🇸 New Brunswick, New Jersey, United States

Vilnius University Emergency Hospital; 🇱🇹 Vilnius, Lithuania

Krakowska Akademia Neurologii Sp. z o. o.; 🇵🇱 Kraków, Malopolskie, Poland

West Tallinn Central Hospital,; 🇪🇪 Tallinn, Estonia

East Tallinn Central Hospital; 🇪🇪 Tallinn, Estonia

P.Stradina university hospital; 🇱🇻 Riga, Latvia

Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie; 🇵🇱 Lublin, Lubelskie, Poland

PALLMED Sp. z o.o.; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Neuro-Care NZOZ; 🇵🇱 Katowice, Poland

Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.; 🇵🇱 Warszawa, Mazowieckie, Poland

Psychiatry and Neurology Hospital Brasov, Neurology Department; 🇷🇴 Brasov, Romania

County Clinical Emergency Hospital Targu Mures, II Neurology Department; 🇷🇴 Targu Mures, Romania

Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska; 🇵🇱 Mosina, Wielkopoloskie, Poland

Euromedis Sp. z o.o.; 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Clinical Rehabilitation Hospital Iasi, Neurology Department; 🇷🇴 Lasi, Romania

Neomed Research; 🇷🇴 Brasov, Romania

Department of Psychiatry and Medical Psychology of Donetsk National Medical University; 🇺🇦 Donetsk, Ukraine

Neurology department of Lviv regional clinical hospital; 🇺🇦 Lviv, Ukraine

Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6; 🇺🇦 Zaporizhzhya, Ukraine

Colentina Clinical Hospital Bucharest, II Neurology Department; 🇷🇴 Bucharest, Romania

CFR Clinical Hospital Constanta, Neurology Department; 🇷🇴 Constanta, Romania

County Clinical Emergency Hospital Timisoara, Neurology Department; 🇷🇴 Timisoara, Romania

Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk regional hospital named after Mechnikov; 🇺🇦 Dnipropetrovsk, Ukraine

County Clinical Emergency Hospital Targu Mures, I Neurology Department; 🇷🇴 Targu Mures, Romania

Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University; 🇺🇦 Donetsk, Ukraine

1st neurology department of Central Clinical Hospital of Ukrzaliznytsya; 🇺🇦 Kharkiv, Ukraine

Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine; 🇺🇦 Kharkiv, Ukraine

Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine; 🇺🇦 Kharkiv, Ukraine

Odessa Regional Clinical Hospital, Dept. of Neurosurgery; 🇺🇦 Odesa, Ukraine

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University Neurology, Inc.; 🇺🇸 Cincinnati, Ohio, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Duke University Medical Center Movement Disorders Center; 🇺🇸 Durham, North Carolina, United States

Mohammed Ali Parkinson's Center; 🇺🇸 Phoenix, Arizona, United States

University of South Florida, Parkinson's Disease and Movement Disorders Center; 🇺🇸 Tampa, Florida, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Wisconsin Institute for Neurologic and Sleep Disorders; 🇺🇸 Milwaukee, Wisconsin, United States

Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida; 🇺🇸 Port Charlotte, Florida, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States