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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.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00880620
First received: April 3, 2009
Last updated: August 16, 2017
Last verified: August 2017
  Purpose
This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.

Condition Intervention Phase
Parkinson's Disease Drug: Placebo Drug: IPX066 95 mg LD Drug: IPX066 145 mg LD Drug: IPX066 195 mg LD Drug: IPX066 245 mg LD Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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:
  • 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.


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: 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 Name: CD-LD ER 95 mg
Drug: IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
Other Name: 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 Name: CD-LD ER 95 mg
Drug: IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
Other Name: CD-LD ER 145 mg
Drug: IPX066 195 mg LD
IPX066 capsule containing 195 mg LD/48.75 mg CD
Other Name: CD-LD ER 195 mg
Drug: IPX066 245 mg LD
IPX066 capsule containing 245 mg LD/61.25 mg CD
Other Name: 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 Name: CD-LD ER 95 mg
Drug: IPX066 145 mg LD
IPX066 capsule containing 145 mg LD/36.25 mg CD
Other Name: CD-LD ER 145 mg
Drug: IPX066 195 mg LD
IPX066 capsule containing 195 mg LD/48.75 mg CD
Other Name: CD-LD ER 195 mg
Drug: IPX066 245 mg LD
IPX066 capsule containing 245 mg LD/61.25 mg CD
Other Name: CD-LD ER 245 mg

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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00880620

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

Publications:
Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov 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: August 16, 2017
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
Carbidopa
Levodopa
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

ClinicalTrials.gov processed this record on August 17, 2017