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A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease (APEX-PD)

This study has been completed.
Information provided by (Responsible Party):
IMPAX Laboratories, Inc. Identifier:
First received: April 3, 2009
Last updated: January 25, 2016
Last verified: January 2016
April 3, 2009
January 25, 2016
April 2009
October 2010   (Final data collection date for primary outcome measure)
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30 [ Time Frame: 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

Unified Parkinson's Disease Rating Scale, parts I-IV [ Time Frame: Week 30 ]
Complete list of historical versions of study NCT00880620 on Archive Site
  • Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: Week 30 ]
    Change from Baseline in Parkinson's disease Questionnaire 39 (PDQ-39) at Week 30 or early discontinuation. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of "Never" (better), "Occasionally", "Sometimes", "Often", and "Always" (worse) in outcome.
  • Safety [ Time Frame: Week 30 ]
  • Parkinson's Disease Questionnaire-39, Patient Global Impression, Clinical Global Impression [ Time Frame: Week 30 ]
  • Safety [ Time Frame: Week 30 ]
Not Provided
Not Provided
A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
This study examines the efficacy of IPX066 as compared to placebo in Parkinson's disease.

A randomized, placebo controlled, fixed dose, parallel arm study of three doses of IPX066 versus placebo.

Approximately 350 subjects were planned to be randomized to receive one of 3 doses of IPX066, or matching placebo, orally in order to complete approximately 300 subjects.

Study duration is approximately 30 weeks for each subject.

The UPDRS is the primary outcome measure.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: placebo
  • Drug: IPX066
    dose level 1
    Other Name: CD-LD ER
  • Drug: IPX066
    dose level 2
    Other Name: CD-LD ER
  • Drug: IPX066
    dose level 3
    Other Name: CD-LD ER
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    IPX066 dose level 1
    Intervention: Drug: IPX066
  • Experimental: 3
    IPX066 dose level 2
    Intervention: Drug: IPX066
  • Experimental: 4
    IPX066 dose level 3
    Intervention: Drug: IPX066
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2010
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. Diagnosed with idiopathic PD.
  3. 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.
  4. 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.
  5. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
  6. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.

Exclusion Criteria:

  1. Pregnant or breastfeeding.
  2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
  3. Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
  4. Use of nonselective MAO inhibitors.
  5. Use of dopamine agonists within 30 days prior to Screening.
  6. Unable to tolerate a placebo regimen, in the Investigator's opinion.
  7. Treatment of psychosis with any antipsychotic.
  8. History of seizure or epilepsy.
  9. Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
  10. History of narrow-angle glaucoma.
  11. Subjects with a history of malignant melanoma.
  12. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
  13. Received any investigational medications during the 30 days prior to Screening.
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   Estonia,   Latvia,   Lithuania,   Romania,   Ukraine,   United States
Not Provided
Not Provided
IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Not Provided
Study Director: Impax Study Director Impax Pharmaceuticals, a division of Impax Laboratories
IMPAX Laboratories, Inc.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP