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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
This study examines the efficacy of IPX066 as compared to placebo in Parkinson's disease.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Study To Evaluate The Safety And Efficacy 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 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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 381
Study Start Date: April 2009
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Drug: placebo
Experimental: 2
IPX066 dose level 1
Drug: IPX066
dose level 1
Other Name: CD-LD ER
Experimental: 3
IPX066 dose level 2
Drug: IPX066
dose level 2
Other Name: CD-LD ER
Experimental: 4
IPX066 dose level 3
Drug: IPX066
dose level 3
Other Name: CD-LD ER

Detailed Description:

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.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  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 identifier: NCT00880620

  Show 60 Study Locations
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Study Director: Impax Study Director Impax Pharmaceuticals, a division of Impax Laboratories
  More Information

Responsible Party: IMPAX Laboratories, Inc. Identifier: NCT00880620     History of Changes
Other Study ID Numbers: IPX066-B08-05
Study First Received: April 3, 2009
Results First Received: December 7, 2015
Last Updated: January 25, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by IMPAX Laboratories, Inc.:
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
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors processed this record on July 21, 2017