Parkinson's Disease
Conditions
Keywords
motor Symptoms, efficacy, IPX066, Parkinson's Disease
Brief summary
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
Detailed description
IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066: * IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease) * IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa - Levodopa) * IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease) All participants will be given IPX066 for 9 months.
Interventions
DRUGIPX066 95 mg
23.75 - 95 mg CD-LD capsules
DRUGIPX066 145 mg
36.25 - 145 mg CD-LD capsules
DRUGIPX066 195 mg
48.75 - 195 mg CD-LD capsules
DRUGIPX066 245 mg
61.25 - 245 mg CD-LD capsules
Sponsors
Impax Laboratories, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Each subject must meet the following inclusion criteria in order to be enrolled in the study: 1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02. 2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.
Exclusion criteria
* Each subject must be free of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III | 9 months | 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 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
| Measure | Time frame | Description |
|---|---|---|
| Total UPDRS Parts I-IV | 9 months | Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy \[In the past week\]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient. 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 |
| Patient Global Impression (PGI) | 9 months | Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale. Patient Global Impression 0-7 - higher value indicates increased improvement from study start |
Countries
Canada, Estonia, Germany, Latvia, Lithuania, Poland, Romania, Spain, Ukraine, United States
Participant flow
Recruitment details
Study dates March 25, 2010 through October 19, 2011 Completion of previous trial a requirement
Participants by arm
| Arm | Count |
|---|---|
| IPX066 Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study. | 617 |
| Total | 617 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Death | 4 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Noncompliance with study drug | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | IPX066 |
|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 9.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 582 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race/Ethnicity, Customized Asian | 3 participants |
| Race/Ethnicity, Customized Black or African American | 3 participants |
| Race/Ethnicity, Customized Other | 3 participants |
| Race/Ethnicity, Customized White | 608 participants |
| Region of Enrollment Canada | 48 participants |
| Region of Enrollment Estonia | 3 participants |
| Region of Enrollment Germany | 19 participants |
| Region of Enrollment Latvia | 2 participants |
| Region of Enrollment Lithuania | 18 participants |
| Region of Enrollment Poland | 50 participants |
| Region of Enrollment Romania | 43 participants |
| Region of Enrollment Spain | 9 participants |
| Region of Enrollment Ukraine | 165 participants |
| Region of Enrollment United States | 260 participants |
| Sex: Female, Male Female | 234 Participants |
| Sex: Female, Male Male | 383 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 122 / 617 |
| serious Total, serious adverse events | 43 / 617 |
Outcome results
Primary
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III
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 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
Time frame: 9 months
Population: All enrolled subjects with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPX066 | Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III | 26.4 units on a scale | Standard Deviation 13.3 |
Secondary
Patient Global Impression (PGI)
Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale. Patient Global Impression 0-7 - higher value indicates increased improvement from study start
Time frame: 9 months
Population: All enrolled subjects with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPX066 | Patient Global Impression (PGI) | 5.4 units on a scale | Standard Deviation 1.16 |
Secondary
Total UPDRS Parts I-IV
Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy \[In the past week\]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient. 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
Time frame: 9 months
Population: All enrolled subjects with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPX066 | Total UPDRS Parts I-IV | 30.5 units on a scale | Standard Deviation 14.67 |