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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: July 23, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS), parts I-IV [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Clinician completed scale of Parkinson's Disease severity


Secondary Outcome Measures:
  • Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Subject completed scale of Parkinson's Disease impact

  • Patient Global Impression (PGI) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Subject's overall impression of study medication


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
Other Name: 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
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

No publications provided

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
Last Updated: July 23, 2012
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
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013