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Completed

NCT Number: NCT01096186

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

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre, University Hospital, London, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Each subject must meet the following inclusion criteria in order to be enrolled in the study:
  • Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.
  • 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:
  • Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
  • Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
  • 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).
  • In the opinion of the Investigator, should not participate in the study.

Treatment and study plan

IPX066 95 mg

Drug

23.75 - 95 mg CD-LD capsules

Other names: CD-LD ER 95 mg

IPX066 145 mg

Drug

36.25 - 145 mg CD-LD capsules

Other names: CD-LD ER 145 mg

IPX066 195 mg

Drug

48.75 - 195 mg CD-LD capsules

Other names: CD-LD ER195 mg

IPX066 245 mg

Drug

61.25 - 245 mg CD-LD capsules

Other names: CD-LD ER 245 mg

Primary outcomes

  1. Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III

    Time frame: 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 outcomes

  1. Total UPDRS Parts I-IV

    Time frame: 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

  2. Patient Global Impression (PGI)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Impax Laboratories, LLC

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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