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

October 25, 2019 updated by: Impax Laboratories, LLC

A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Total of 427 subjects were screened and 381 were randomized and received one of the four treatment groups (1) placebo (N=92), (2) IPX066 145 mg LD (N=87) (3) IPX066 245 mg LD (N=104) (4) IPX066 390 mg LD (N=98) three times a day.

Study duration is approximately 30 weeks for each subject including 4 weeks of titration (up to 3 weeks of dose escalation and I week of stabilization for safe escalation to the allocated dose), and 26 weeks of maintenance.

During the titration phase:

The following dose strengths were used to titrate up to the final three strengths that were assigned to the three IPX066 treatment arms.

IPX066 95 mg LD capsule containing 95 mg LD and 23.75 mg CD. IPX066 145 mg LD capsule containing 145 mg LD and 36.25 mg CD. IPX066 195 mg LD capsule containing 195 mg LD and 48.75 mg CD. IPX066 245 mg LD capsule containing 245 mg LD and 61.25 mg CD.

During the maintenance phase:

IPX066 145 mg LD treatment arm received 145 mg LD and 36.25 mg CD. IPX066 245 mg LD treatment arm received 245 mg LD and 61.25 mg CD. IPX066 390 mg LD treatment arm received 390 mg LD and 97.50 mg CD.

Primary efficacy outcome measure was change from baseline in the sum of UPDRS Part II and Part III scores at the end of study or last value reported if subject discontinued prematurely.

Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score.

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R 3X5
        • Memory and Motor Skills Clinic
    • Alberta
      • Edmonton, Alberta, Canada, T5G 0B7
        • Movement Disorders Clinic, Glenrose Rehabilitation Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3J2H7
        • Saint Boniface Clinic
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Science Center
      • Ottawa, Ontario, Canada, K1G 4G3
        • Parkinson's and Neurodegenerative Disorders Clinic
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital Civic Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • University of Sherbrooke
  • Estonia
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital
      • Tallinn, Estonia, 10617
        • West Tallin Central Hopsital
  • Latvia
      • Riga, Latvia, 1002
        • P.Stradina university hospital
      • Riga, Latvia
        • Gailezers hospital
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Kaunas Medical University Hospital
      • Siauliai, Lithuania, LT- 76231
        • Siauliai Regional Hospital
      • Vilnius, Lithuania, LT-04130
        • Vilnius University Emergency Hospital
      • Vilnius, Lithuania, LT-08420
        • Vilnius University Centre of Gerontology and Rehabilitation
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santariskiu Klinikos
  • Romania
      • Brasov, Romania, 500123
        • Psychiatry and Neurology Hospital, Neurology Department
      • Bucharest, Romania, 020125
        • Colentina Clinical Hospital Bucharest, II Neurology Department
      • Cluj Napoca, Romania, 400012
        • County Emergency Clinical Hospital Cluj-Napoca, I Neurology Clinic
      • Constanta, Romania, 900123
        • CFR Clinical Hospital Constanta
      • Iasi, Romania
        • Clinical Rehabilitation Hospital Iasi, Neurology Department
      • Targu Mures, Romania, 540136
        • County Clinical Emergency Hospital, Targu Mures, II Neurology Department,
      • Timisoara, Romania, 300736
        • County Clinical Emergency Hospital Timisoara
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49005
        • Neurology department of Regional hospital named after Mechnikov
      • Donetsk, Ukraine, 83037
        • Department of Psychiatry and Medical Psychology of Donetsk National Medical University
      • Donetsk, Ukraine, 83099
        • Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
      • Kharkiv, Ukraine, Kharkiv
        • 1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
      • Kiev, Ukraine, 04114
        • Institute of Gerontology Parkinson's Disease Center
      • Lviv, Ukraine, 79010
        • Neurology department of Lviv regional clinical hospital
      • Poltava, Ukraine, 36000
        • Neurology department of Medical Dental Academy based on Poltava regional hospital
      • Vinnitsa, Ukraine, 21018
        • Neurology department of Vinnitsa Medical University
      • Zaporozhye, Ukraine, 69035
        • Neurology department, Zaporozhye State Medical University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham, Dept. of Neurology
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute, LLC
    • California
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, Inc.
      • La Jolla, California, United States, 92037
        • Coordinated Clinical Research
      • La Jolla, California, United States, 92037
        • Coastal Neurological Medical Group
      • Sunnyvale, California, United States, 94085
        • The Parkinson's Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Neurology Clinics, Temple Medical Center
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center, Inc.
      • Hollywood, Florida, United States, 23021
        • Sunrise Clinical Research, Inc.
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Port Charlotte, Florida, United States, 33952
        • Charlotte Neurological Services
      • Saint Petersburg, Florida, United States, 33713
        • Suncoast Neuroscience Associates, Inc.
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Idaho
      • Boise, Idaho, United States, 83702
        • Idaho Elks Rehabilitation Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center, Dept. of Neurological Sciences
    • Kansas
      • Kansas City, Kansas, United States, 66160-7314
        • Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Quest Research Institute
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • Struthers Parkinson's Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University, Dept. of Neurology
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center Movement Disorders Center
    • Ohio
      • Toledo, Ohio, United States, 43614
        • University of Toledo
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine, Parkinson's Disease Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Wisconsin Institute for Neurologic and Sleep Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
One Placebo capsule was given TID for the first 21 days. Two placebo capsules were given TID on days 22 till end of study (week 30).
Drug: Placebo
Placebo
Experimental: IPX066 145 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
Drug: Placebo
Placebo
Drug: IPX066 95 mg LD
IPX066 capsule containing 95 mg LD/23.75 mg CD
Other Names:
  • CD-LD ER 95 mg
Drug: IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
Other Names:
  • CD-LD ER 145 mg
Experimental: IPX066 245 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. One IPX066 245 mg LD and one placebo capsule were given TID on days 22 till end of study (week 30).
Drug: Placebo
Placebo
Drug: IPX066 95 mg LD
IPX066 capsule containing 95 mg LD/23.75 mg CD
Other Names:
  • CD-LD ER 95 mg
Drug: IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
Other Names:
  • CD-LD ER 145 mg
Drug: IPX066 195 mg LD
IPX066 capsule containing 195 mg LD/48.75 mg CD
Other Names:
  • CD-LD ER 195 mg
Drug: IPX066 245 mg LD
IPX066 capsule containing 245 mg LD/61.25 mg CD
Other Names:
  • CD-LD ER 245 mg
Experimental: IPX066 390 mg LD
One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-7. One IPX066 195 mg LD was given TID on days 8-14. One IPX066 245 mg LD was given TID on days 15-21. Two IPX066 195 mg LD capsules were given TID on days 22 till end of study (week 30).
Drug: IPX066 95 mg LD
IPX066 capsule containing 95 mg LD/23.75 mg CD
Other Names:
  • CD-LD ER 95 mg
Drug: IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
Other Names:
  • CD-LD ER 145 mg
Drug: IPX066 195 mg LD
IPX066 capsule containing 195 mg LD/48.75 mg CD
Other Names:
  • CD-LD ER 195 mg
Drug: IPX066 245 mg LD
IPX066 capsule containing 245 mg LD/61.25 mg CD
Other Names:
  • CD-LD ER 245 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Time Frame: Baseline and Week 30 (or End of Study)
Change from Baseline in Parkinson's disease Questionnaire 39 (PDQ-39) at Weeks 4, 9, 16, 23 and 30 or early discontinuation was collected. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of "Never" (better in outcome), (value 0), "Occasionally" (value 1), "Sometimes" (value 2), , "Often" (value 3), and "Always" (value 4), (worse in outcome). The minimum possible score is "0" and the maximum is "156". The outcome measure calculated was the change from baseline to end of study in mean PDQ-39 score. Negative values indicate a better result.
Baseline and Week 30 (or End of Study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Impax Laboratories, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (Estimate)

April 14, 2009

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPX066-B08-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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