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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01096186
First received: March 25, 2010
Last updated: February 4, 2016
Last verified: September 2013
  Purpose
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

Condition Intervention Phase
Parkinson's Disease
Drug: IPX066
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by IMPAX Laboratories, Inc.:

Primary Outcome Measures:
  • Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III [ Time Frame: 9 months ] [ Designated as safety issue: No ]

    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:
  • Total UPDRS Parts I-IV [ Time Frame: 9 months ] [ Designated as safety issue: No ]

    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) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

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

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



Enrollment: 617
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open Label IPX066
IPX066
Drug: IPX066
IPX066

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096186

  Show 81 Study Locations
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Study Director: IPX066-B09-03 Impax Study Director Impax Pharmaceuticals, a division of Impax Laboratories
  More Information

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01096186     History of Changes
Other Study ID Numbers: IPX066-B09-03 
Study First Received: March 25, 2010
Results First Received: December 9, 2015
Last Updated: February 4, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by IMPAX Laboratories, Inc.:
motor Symptoms
efficacy
IPX066
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Carbidopa, levodopa drug combination
Adjuvants, Immunologic
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 04, 2016