Trial Outcomes & Findings for A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease (NCT NCT00880620)
NCT ID: NCT00880620
Last Updated: 2019-10-29
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
381 participants
Primary outcome timeframe
Week 30
Results posted on
2019-10-29
Participant Flow
First patient enrolled: 4/13/2009 Last patient out 10/05/2010
Following enrollment, subjects were randomized into one of the four treatment groups.
Participant milestones
| Measure |
Placebo
Placebo capsules were used
|
IPX066 145 mg LD
IPX066 capsule containing 145 mg levodopa and 36.25 mg carbidopa
|
IPX066 245 mg LD
IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
|
IPX066 390 mg LD
IPX066 capsules that contained 390 mg levodopa and 97.5 mg carbidopa
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
92
|
87
|
104
|
98
|
|
Overall Study
Week 4
|
88
|
79
|
94
|
86
|
|
Overall Study
Week 9
|
80
|
73
|
88
|
78
|
|
Overall Study
Week 16
|
74
|
73
|
87
|
74
|
|
Overall Study
Week 23
|
71
|
72
|
85
|
74
|
|
Overall Study
COMPLETED
|
71
|
72
|
83
|
74
|
|
Overall Study
NOT COMPLETED
|
21
|
15
|
21
|
24
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsules were used
|
IPX066 145 mg LD
IPX066 capsule containing 145 mg levodopa and 36.25 mg carbidopa
|
IPX066 245 mg LD
IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
|
IPX066 390 mg LD
IPX066 capsules that contained 390 mg levodopa and 97.5 mg carbidopa
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
15
|
15
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
12
|
4
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
1
|
3
|
|
Overall Study
Noncompliance
|
0
|
0
|
1
|
1
|
|
Overall Study
Other
|
1
|
1
|
2
|
2
|
Baseline Characteristics
A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=92 Participants
Placebo capsules were used
|
IPX066 145 mg LD
n=87 Participants
IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
|
IPX066 245 mg LD
n=104 Participants
IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
|
IPX066 390 mg LD
n=98 Participants
IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
|
Total
n=381 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 9.81 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 9.32 • n=4 Participants
|
64.8 years
STANDARD_DEVIATION 9.55 • n=21 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
169 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
345 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
90 participants
n=5 Participants
|
87 participants
n=7 Participants
|
102 participants
n=5 Participants
|
96 participants
n=4 Participants
|
375 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
37 participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
15 participants
n=5 Participants
|
14 participants
n=4 Participants
|
55 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
37 participants
n=5 Participants
|
38 participants
n=4 Participants
|
134 participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
32 participants
n=5 Participants
|
26 participants
n=4 Participants
|
115 participants
n=21 Participants
|
|
Region of Enrollment
Lithuania
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Region of Enrollment
Estonia
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Age at Parkinson's disease onset
|
63.7 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 10.71 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 9.38 • n=4 Participants
|
63.0 years
STANDARD_DEVIATION 10.00 • n=21 Participants
|
|
Duration of Parkinson's disease
|
1.8 years
STANDARD_DEVIATION 2.01 • n=5 Participants
|
2.3 years
STANDARD_DEVIATION 3.08 • n=7 Participants
|
1.8 years
STANDARD_DEVIATION 1.85 • n=5 Participants
|
2.0 years
STANDARD_DEVIATION 2.33 • n=4 Participants
|
2.0 years
STANDARD_DEVIATION 2.34 • n=21 Participants
|
|
UPDRS Parts II and III Score
|
36.3 units on a scale
STANDARD_DEVIATION 11.89 • n=5 Participants
|
36.1 units on a scale
STANDARD_DEVIATION 13.56 • n=7 Participants
|
38.1 units on a scale
STANDARD_DEVIATION 15.63 • n=5 Participants
|
36.3 units on a scale
STANDARD_DEVIATION 13.04 • n=4 Participants
|
36.7 units on a scale
STANDARD_DEVIATION 13.63 • n=21 Participants
|
|
Hoehn and Yahr Stage
Stage I
|
7 units on a scale
n=5 Participants
|
6 units on a scale
n=7 Participants
|
13 units on a scale
n=5 Participants
|
14 units on a scale
n=4 Participants
|
40 units on a scale
n=21 Participants
|
|
Hoehn and Yahr Stage
Stage II
|
69 units on a scale
n=5 Participants
|
62 units on a scale
n=7 Participants
|
65 units on a scale
n=5 Participants
|
62 units on a scale
n=4 Participants
|
258 units on a scale
n=21 Participants
|
|
Hoehn and Yahr Stage
Remaining
|
16 units on a scale
n=5 Participants
|
19 units on a scale
n=7 Participants
|
26 units on a scale
n=5 Participants
|
22 units on a scale
n=4 Participants
|
83 units on a scale
n=21 Participants
|
|
MMSE
|
28.9 units on a scale
STANDARD_DEVIATION 1.18 • n=5 Participants
|
29.0 units on a scale
STANDARD_DEVIATION 1.27 • n=7 Participants
|
28.7 units on a scale
STANDARD_DEVIATION 1.21 • n=5 Participants
|
28.9 units on a scale
STANDARD_DEVIATION 1.18 • n=4 Participants
|
28.9 units on a scale
STANDARD_DEVIATION 1.21 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 30Population: Analysis included all treated subjects with at least one efficacy measurement after dosing. Subjects who had no post-baseline efficacy assessments (N4) and those who had early termination assessments\>3 days after last dose and no other post-baseline measurements (N16) were not included in the efficacy analysis set. Randomized (381)-(4+16) = 361.
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
Outcome measures
| Measure |
Placebo
n=90 Participants
Placebo capsules were used
|
IPX066 145mg LD
n=82 Participants
IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
|
IPX066 245 mg LD
n=99 Participants
IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
|
IPX066 390 mg LD
n=90 Participants
IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
|
|---|---|---|---|---|
|
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
|
-0.6 units on a scale
Standard Deviation 10.37
|
-11.7 units on a scale
Standard Deviation 10.97
|
-12.9 units on a scale
Standard Deviation 11.42
|
-14.9 units on a scale
Standard Deviation 11.85
|
SECONDARY outcome
Timeframe: Baseline and Week 30 (or End of Study)Population: Subjects who had no postbaseline efficacy assessments (N=4) and those who had early termination assessments \>3 days after last dose and no other postbaseline measurements (N=16) were not included in the efficacy analysis. 2 subjects without a baseline measurement, 1 each from 145mg and 390mg arm were also excluded. Randomized 381-4-16-2=359.
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.
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo capsules were used
|
IPX066 145mg LD
n=99 Participants
IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
|
IPX066 245 mg LD
n=89 Participants
IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
|
IPX066 390 mg LD
n=90 Participants
IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
|
|---|---|---|---|---|
|
Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score
|
-4.4 score on a scale
Standard Deviation 12.18
|
-3.8 score on a scale
Standard Deviation 12.16
|
-6.0 score on a scale
Standard Deviation 12.30
|
0.6 score on a scale
Standard Deviation 11.10
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
IPX066 145 mg LD
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
IPX066 245 mg LD
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
IPX066 390 mg LD
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=92 participants at risk
Placebo capsules were used
|
IPX066 145 mg LD
n=87 participants at risk
IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
|
IPX066 245 mg LD
n=104 participants at risk
IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
|
IPX066 390 mg LD
n=98 participants at risk
IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/92 • 1 year, 6 months
|
1.1%
1/87 • Number of events 1 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/92 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.96%
1/104 • Number of events 1 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/92 • 1 year, 6 months
|
1.1%
1/87 • Number of events 1 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/92 • 1 year, 6 months
|
1.1%
1/87 • Number of events 1 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/92 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.96%
1/104 • Number of events 1 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/92 • 1 year, 6 months
|
1.1%
1/87 • Number of events 1 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/92 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
1.0%
1/98 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
Urosepsis
|
1.1%
1/92 • Number of events 1 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/92 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.96%
1/104 • Number of events 1 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/92 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.96%
1/104 • Number of events 1 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
1/92 • Number of events 1 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/92 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
1.0%
1/98 • Number of events 1 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/92 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
1.0%
1/98 • Number of events 1 • 1 year, 6 months
|
|
Surgical and medical procedures
Coronary Artery Bypass
|
0.00%
0/92 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.96%
1/104 • Number of events 1 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
|
Surgical and medical procedures
Prostatectomy
|
1.1%
1/92 • Number of events 1 • 1 year, 6 months
|
0.00%
0/87 • 1 year, 6 months
|
0.00%
0/104 • 1 year, 6 months
|
0.00%
0/98 • 1 year, 6 months
|
Other adverse events
| Measure |
Placebo
n=92 participants at risk
Placebo capsules were used
|
IPX066 145 mg LD
n=87 participants at risk
IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
|
IPX066 245 mg LD
n=104 participants at risk
IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
|
IPX066 390 mg LD
n=98 participants at risk
IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.7%
8/92 • 1 year, 6 months
|
13.8%
12/87 • 1 year, 6 months
|
19.2%
20/104 • 1 year, 6 months
|
20.4%
20/98 • 1 year, 6 months
|
|
Nervous system disorders
Headache
|
10.9%
10/92 • 1 year, 6 months
|
6.9%
6/87 • 1 year, 6 months
|
12.5%
13/104 • 1 year, 6 months
|
17.3%
17/98 • 1 year, 6 months
|
|
Nervous system disorders
Dizziness
|
5.4%
5/92 • 1 year, 6 months
|
9.2%
8/87 • 1 year, 6 months
|
19.2%
20/104 • 1 year, 6 months
|
12.2%
12/98 • 1 year, 6 months
|
|
Psychiatric disorders
Insomnia
|
3.3%
3/92 • 1 year, 6 months
|
2.3%
2/87 • 1 year, 6 months
|
8.7%
9/104 • 1 year, 6 months
|
6.1%
6/98 • 1 year, 6 months
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/92 • 1 year, 6 months
|
2.3%
2/87 • 1 year, 6 months
|
5.8%
6/104 • 1 year, 6 months
|
5.1%
5/98 • 1 year, 6 months
|
|
Gastrointestinal disorders
Dry Mouth
|
1.1%
1/92 • 1 year, 6 months
|
3.4%
3/87 • 1 year, 6 months
|
1.9%
2/104 • 1 year, 6 months
|
7.1%
7/98 • 1 year, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
3/92 • 1 year, 6 months
|
2.3%
2/87 • 1 year, 6 months
|
1.9%
2/104 • 1 year, 6 months
|
5.1%
5/98 • 1 year, 6 months
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/92 • 1 year, 6 months
|
2.3%
2/87 • 1 year, 6 months
|
5.8%
6/104 • 1 year, 6 months
|
2.0%
2/98 • 1 year, 6 months
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/92 • 1 year, 6 months
|
2.3%
2/87 • 1 year, 6 months
|
3.8%
4/104 • 1 year, 6 months
|
5.1%
5/98 • 1 year, 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/92 • 1 year, 6 months
|
2.3%
2/87 • 1 year, 6 months
|
2.9%
3/104 • 1 year, 6 months
|
5.1%
5/98 • 1 year, 6 months
|
|
Psychiatric disorders
Depression
|
5.4%
5/92 • 1 year, 6 months
|
1.1%
1/87 • 1 year, 6 months
|
1.9%
2/104 • 1 year, 6 months
|
2.0%
2/98 • 1 year, 6 months
|
|
Vascular disorders
Orthostatic Hypotension
|
1.1%
1/92 • 1 year, 6 months
|
1.1%
1/87 • 1 year, 6 months
|
0.96%
1/104 • 1 year, 6 months
|
5.1%
5/98 • 1 year, 6 months
|
Additional Information
Kaihong Jiang, Senior Director, Head of Biometrics
Impax Laboratories, LLC
Phone: 908-307-2234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results of the Study conducted at the Site shall not be made before the first multi-site publication by Sponsor.
- Publication restrictions are in place
Restriction type: OTHER