A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease

NCT00880620 | Completed Phase 3 Results

• 1 other identifier: IPX066-B08-05
• Study Type: interventional
• Target: 381
• Locations: 7 countries
• Sites: 60

Brief Summary

This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30

  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 Week 30 (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

  Week 30

Secondary Outcomes (1)

• Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score

  Baseline and Week 30 (or End of Study)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

One Placebo capsule was given TID for the first 21 days. Two placebo capsules were given TID on days 22 till end of study (week 30).

Drug: Placebo

IPX066 145 mg LD

EXPERIMENTAL

One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).

Drug: Placebo; Drug: IPX066 95 mg LD; Drug: IPX066 145 mg LD

IPX066 245 mg LD

EXPERIMENTAL

One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).

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

IPX066 390 mg LD

EXPERIMENTAL

One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).

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

Interventions

Placebo DRUG

Placebo

IPX066 145 mg LD; IPX066 245 mg LD; Placebo

IPX066 95 mg LD DRUG

IPX066 capsule containing 95 mg LD/23.75 mg CD

Also known as: CD-LD ER 95 mg

IPX066 145 mg LD; IPX066 245 mg LD; IPX066 390 mg LD

IPX066 145 mg LD DRUG

IPX066 capsule containing 145 mg LD/36.25 mg CD

Also known as: CD-LD ER 145 mg

IPX066 145 mg LD; IPX066 245 mg LD; IPX066 390 mg LD

IPX066 195 mg LD DRUG

IPX066 capsule containing 195 mg LD/48.75 mg CD

Also known as: CD-LD ER 195 mg

IPX066 245 mg LD; IPX066 390 mg LD

IPX066 245 mg LD DRUG

IPX066 capsule containing 245 mg LD/61.25 mg CD

Also known as: CD-LD ER 245 mg

IPX066 245 mg LD; IPX066 390 mg LD

Eligibility Criteria

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

You may qualify if:

• Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable.
• Diagnosed with idiopathic PD.
• LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
• If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation.
• Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
• Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.

You may not qualify if:

• Pregnant or breastfeeding.
• Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
• Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
• Use of nonselective MAO inhibitors.
• Use of dopamine agonists within 30 days prior to Screening.
• Unable to tolerate a placebo regimen, in the Investigator's opinion.
• Treatment of psychosis with any antipsychotic.
• History of seizure or epilepsy.
• Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
• History of narrow-angle glaucoma.
• Subjects with a history of malignant melanoma.
• History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
• Received any investigational medications during the 30 days prior to Screening.

Sponsors & Collaborators

• Impax Laboratories, LLC: lead

Study Sites (60)

University of Alabama at Birmingham, Dept. of Neurology

Birmingham, Alabama, 35233, United States

Location

HOPE Research Institute, LLC

Phoenix, Arizona, 85050, United States

Location

Collaborative NeuroScience Network, Inc.

Garden Grove, California, 92845, 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

Yale Neurology Clinics, Temple Medical Center

New Haven, Connecticut, 06510, United States

Location

Bradenton Research Center, Inc.

Bradenton, Florida, 34205, United States

Location

Sunrise Clinical Research, Inc.

Hollywood, Florida, 23021, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Charlotte Neurological Services

Port Charlotte, Florida, 33952, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33713, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Idaho Elks Rehabilitation Hospital

Boise, Idaho, 83702, United States

Location

Rush University Medical Center, Dept. of Neurological Sciences

Chicago, Illinois, 60612, United States

Location

Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center

Kansas City, Kansas, 66160-7314, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, 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

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

State University of New York Upstate Medical University, Dept. of Neurology

Syracuse, New York, 13210, United States

Location

Duke University Medical Center Movement Disorders Center

Durham, North Carolina, 27705, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Baylor College of Medicine, Parkinson's Disease Center

Houston, Texas, 77030, United States

Location

Wisconsin Institute for Neurologic and Sleep Disorders

Milwaukee, Wisconsin, 53233, United States

Location

Movement Disorders Clinic, Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

Saint Boniface Clinic

Winnipeg, Manitoba, R3J2H7, Canada

Location

London Health Science Center

London, Ontario, N6A 5A5, Canada

Location

Parkinson's and Neurodegenerative Disorders Clinic

Ottawa, Ontario, K1G 4G3, Canada

Location

Ottawa Hospital Civic Site

Ottawa, Ontario, K1Y 4E9, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Memory and Motor Skills Clinic

Québec, Quebec, G1R 3X5, Canada

Location

University of Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

West Tallin Central Hopsital

Tallinn, 10617, Estonia

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

Vilnius University Emergency Hospital

Vilnius, LT-04130, Lithuania

Location

Vilnius University Centre of Gerontology and Rehabilitation

Vilnius, LT-08420, Lithuania

Location

Vilnius University Hospital Santariskiu klinikos

Vilnius, LT-08661, Lithuania

Location

Psychiatry and Neurology Hospital, Neurology Department

Brasov, 500123, Romania

Location

Colentina Clinical Hospital Bucharest, II Neurology Department

Bucharest, 020125, Romania

Location

County Emergency Clinical Hospital Cluj-Napoca, I Neurology Clinic

Cluj-Napoca, 400012, Romania

Location

CFR Clinical Hospital Constanta

Constanța, 900123, Romania

Location

Clinical Rehabilitation Hospital Iasi, Neurology Department

Iași, Romania

Location

County Clinical Emergency Hospital, Targu Mures, II Neurology Department,

Târgu Mureş, 540136, Romania

Location

County Clinical Emergency Hospital Timisoara

Timișoara, 300736, Romania

Location

Neurology department of Regional hospital named after Mechnikov

Dnipro, 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, Kharkiv, Ukraine

Location

Institute of Gerontology Parkinson's Disease Center

Kiev, 04114, Ukraine

Location

Neurology department of Lviv regional clinical hospital

Lviv, 79010, Ukraine

Location

Neurology department of Medical Dental Academy based on Poltava regional hospital

Poltava, 36000, Ukraine

Location

Neurology department of Vinnitsa Medical University

Vinnitsa, 21018, Ukraine

Location

Neurology department, Zaporozhye State Medical University

Zaporizhzhya, 69035, Ukraine

Location

Related Publications (1)

• Pahwa R, Lyons KE, Hauser RA, Fahn S, Jankovic J, Pourcher E, Hsu A, O'Connell M, Kell S, Gupta S; APEX-PD Investigators. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease. Parkinsonism Relat Disord. 2014 Feb;20(2):142-8. doi: 10.1016/j.parkreldis.2013.08.017. Epub 2013 Sep 5.

  PMID: 24055014 BACKGROUND

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: Kaihong Jiang, Senior Director, Head of Biometrics
• Organization: Impax Laboratories, LLC

kaihong.jiang@amneal.com

908-307-2234

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 14, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 29, 2019
• Results First Posted: February 22, 2016

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (5); UA (9); CA (8); US (27); ES (2); LA (2); RO (7)