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

COMPLETEDPHASE3

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

NCT01096186•Impax Laboratories, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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.

Locations (81)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mohammed Ali Parkinson's Center

Phoenix, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

Clinical Trials Inc.

Little Rock, Arkansas, United States

Coastal Neurological Medical Group

La Jolla, California, United States

Coordinated Clinical Research

La Jolla, California, United States

The Parkinson's Institute

Sunnyvale, 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

Key Dates

Start Date

March 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

November 8, 2019

Enrollment

617

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

IPX066 95 mg

DRUG

IPX066 145 mg

DRUG

IPX066 195 mg

DRUG

IPX066 245 mg

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

View study

RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations