This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
April 3, 2009
August 16, 2017
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 ClinicalTrials.gov Archive Site
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.
  • 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 three doses of IPX066 as compared to placebo in Parkinson's disease.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • 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
  • 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).
    Intervention: Drug: 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).
    Interventions:
    • Drug: Placebo
    • Drug: IPX066 95 mg LD
    • Drug: IPX066 145 mg LD
  • 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).
    Interventions:
    • Drug: Placebo
    • Drug: IPX066 95 mg LD
    • Drug: IPX066 145 mg LD
    • Drug: IPX066 195 mg LD
    • Drug: IPX066 245 mg LD
  • 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).
    Interventions:
    • Drug: IPX066 95 mg LD
    • Drug: IPX066 145 mg LD
    • Drug: IPX066 195 mg LD
    • Drug: IPX066 245 mg LD
Pahwa R, Lyons KE, Hauser RA, Fahn S, Jankovic J, Pourcher E, Hsu A, O'Connell M, Kell S, Gupta S; APEX-PD Investigators. Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson's disease. Parkinsonism Relat Disord. 2014 Feb;20(2):142-8. doi: 10.1016/j.parkreldis.2013.08.017. Epub 2013 Sep 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
381
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)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Estonia,   Latvia,   Lithuania,   Romania,   Ukraine,   United States
 
 
NCT00880620
IPX066-B08-05
No
Not Provided
Plan to Share IPD: No
IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc.
Not Provided
Study Director: Impax Study Director Impax Pharmaceuticals, a division of Impax Laboratories
IMPAX Laboratories, Inc.
August 2017

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