Trial Outcomes & Findings for Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study (NCT NCT01411137)
NCT ID: NCT01411137
Last Updated: 2019-11-07
Results Overview
At Part 1 Week 6, Part 2 Month 3 and Month 6 or at Early Termination, the subjects rated the change in their condition with IPX066 treatment from their condition prior to Part 1 Visit 1(Baseline) using Patient Global Impression (PGI) 7-point scale. 1=very much worse and 7=very much improved.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
6 months
Results posted on
2019-11-07
Participant Flow
Date first subject enrolled: August 19, 2011 Date last subject completed: March 20, 2013
Participant milestones
| Measure |
IPX066
extended-release CD-LD
|
|---|---|
|
Part 1: Dose Conversion
STARTED
|
43
|
|
Part 1: Dose Conversion
COMPLETED
|
33
|
|
Part 1: Dose Conversion
NOT COMPLETED
|
10
|
|
Part 2: Open-Label Extension
STARTED
|
32
|
|
Part 2: Open-Label Extension
COMPLETED
|
25
|
|
Part 2: Open-Label Extension
NOT COMPLETED
|
7
|
|
Part 3: Open-Label Extension
STARTED
|
12
|
|
Part 3: Open-Label Extension
COMPLETED
|
12
|
|
Part 3: Open-Label Extension
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=43 Participants
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsAt Part 1 Week 6, Part 2 Month 3 and Month 6 or at Early Termination, the subjects rated the change in their condition with IPX066 treatment from their condition prior to Part 1 Visit 1(Baseline) using Patient Global Impression (PGI) 7-point scale. 1=very much worse and 7=very much improved.
Outcome measures
| Measure |
Part 1: Conversion
n=33 Participants
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
|
Part 2: Open-Label Extension (Month 3)
n=26 Participants
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 2: Open-Label Extension (Month 6)
n=25 Participants
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 1 or 2 Early Termination
n=15 Participants
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 1 or 2 Early Termination
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
|---|---|---|---|---|---|
|
Patient Global Impression (PGI)
|
5.2 units on a scale
Standard Deviation 1.35
|
5.4 units on a scale
Standard Deviation 1.30
|
5.3 units on a scale
Standard Deviation 1.49
|
2.8 units on a scale
Standard Deviation 1.21
|
—
|
PRIMARY outcome
Timeframe: 6 monthsClinician-reported satisfaction outcome of IPX066 using Clinical Global Impression (PGI) 7-point scale. At Part 1 Week 6; Part 2 Month 3, and Month 6 or at Early Termination, the Investigator rated how much a subject's overall condition had changed since Part 1 Visit 1 (Baseline) using 7-point scale. 1=very much worse and 7=very much improved.
Outcome measures
| Measure |
Part 1: Conversion
n=33 Participants
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
|
Part 2: Open-Label Extension (Month 3)
n=26 Participants
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 2: Open-Label Extension (Month 6)
n=25 Participants
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 1 or 2 Early Termination
n=15 Participants
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 1 or 2 Early Termination
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
|---|---|---|---|---|---|
|
Clinical Global Impression (CGI)
|
5.5 units on a scale
Standard Deviation 1.15
|
5.7 units on a scale
Standard Deviation 1.08
|
5.6 units on a scale
Standard Deviation 1.39
|
3.7 units on a scale
Standard Deviation 0.80
|
—
|
PRIMARY outcome
Timeframe: 6 monthsChange from Baseline in Parkinson's disease Questionnaire-8 (PDQ-8) at End of Study or early discontinuation. The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).
Outcome measures
| Measure |
Part 1: Conversion
n=43 Participants
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
|
Part 2: Open-Label Extension (Month 3)
n=33 Participants
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 2: Open-Label Extension (Month 6)
n=26 Participants
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 1 or 2 Early Termination
n=25 Participants
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 1 or 2 Early Termination
n=15 Participants
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
|---|---|---|---|---|---|
|
Parkinson's Disease Questionnaire-8 (PDQ-8)
|
9.6 units on a scale
Standard Deviation 5.49
|
8.1 units on a scale
Standard Deviation 4.62
|
8.5 units on a scale
Standard Deviation 4.79
|
9.0 units on a scale
Standard Deviation 5.91
|
11.8 units on a scale
Standard Deviation 6.62
|
Adverse Events
Part 1: Conversion
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Part 2: Open-Label Extension 1
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 3: Open-Label Extension 2
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Overall
Serious events: 9 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Conversion
n=43 participants at risk
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
|
Part 2: Open-Label Extension 1
n=32 participants at risk
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 3: Open-Label Extension 2
n=12 participants at risk
Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, a 6-month open-label extension study.
|
Overall
n=43 participants at risk
All treated subjects
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
3.1%
1/32 • Number of events 1 • 58 weeks
|
0.00%
0/12 • 58 weeks
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/43 • 58 weeks
|
3.1%
1/32 • Number of events 1 • 58 weeks
|
0.00%
0/12 • 58 weeks
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/43 • 58 weeks
|
3.1%
1/32 • Number of events 1 • 58 weeks
|
0.00%
0/12 • 58 weeks
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/43 • 58 weeks
|
3.1%
1/32 • Number of events 1 • 58 weeks
|
0.00%
0/12 • 58 weeks
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/43 • 58 weeks
|
3.1%
1/32 • Number of events 1 • 58 weeks
|
8.3%
1/12 • Number of events 1 • 58 weeks
|
4.7%
2/43 • Number of events 2 • 58 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/43 • 58 weeks
|
3.1%
1/32 • Number of events 1 • 58 weeks
|
0.00%
0/12 • 58 weeks
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/43 • 58 weeks
|
0.00%
0/32 • 58 weeks
|
16.7%
2/12 • Number of events 2 • 58 weeks
|
4.7%
2/43 • Number of events 2 • 58 weeks
|
Other adverse events
| Measure |
Part 1: Conversion
n=43 participants at risk
Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
|
Part 2: Open-Label Extension 1
n=32 participants at risk
Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
|
Part 3: Open-Label Extension 2
n=12 participants at risk
Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, a 6-month open-label extension study.
|
Overall
n=43 participants at risk
All treated subjects
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.6%
5/43 • Number of events 5 • 58 weeks
|
6.2%
2/32 • Number of events 2 • 58 weeks
|
0.00%
0/12 • 58 weeks
|
16.3%
7/43 • Number of events 7 • 58 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
7.0%
3/43 • Number of events 3 • 58 weeks
|
15.6%
5/32 • Number of events 5 • 58 weeks
|
0.00%
0/12 • 58 weeks
|
18.6%
8/43 • Number of events 8 • 58 weeks
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.00%
0/43 • 58 weeks
|
0.00%
0/32 • 58 weeks
|
8.3%
1/12 • Number of events 1 • 58 weeks
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
3/43 • Number of events 3 • 58 weeks
|
6.2%
2/32 • Number of events 2 • 58 weeks
|
16.7%
2/12 • Number of events 2 • 58 weeks
|
11.6%
5/43 • Number of events 5 • 58 weeks
|
|
Nervous system disorders
Dyskinesia
|
7.0%
3/43 • Number of events 3 • 58 weeks
|
3.1%
1/32 • Number of events 1 • 58 weeks
|
0.00%
0/12 • 58 weeks
|
9.3%
4/43 • Number of events 4 • 58 weeks
|
|
Psychiatric disorders
Anxiety
|
4.7%
2/43 • Number of events 2 • 58 weeks
|
6.2%
2/32 • Number of events 2 • 58 weeks
|
8.3%
1/12 • Number of events 1 • 58 weeks
|
11.6%
5/43 • Number of events 5 • 58 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/43 • 58 weeks
|
0.00%
0/32 • 58 weeks
|
8.3%
1/12 • Number of events 1 • 58 weeks
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
|
Psychiatric disorders
Hallucination
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
6.2%
2/32 • Number of events 2 • 58 weeks
|
0.00%
0/12 • 58 weeks
|
7.0%
3/43 • Number of events 3 • 58 weeks
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
3.1%
1/32 • Number of events 1 • 58 weeks
|
8.3%
1/12 • Number of events 1 • 58 weeks
|
4.7%
2/43 • Number of events 2 • 58 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/43 • 58 weeks
|
0.00%
0/32 • 58 weeks
|
8.3%
1/12 • Number of events 1 • 58 weeks
|
2.3%
1/43 • Number of events 1 • 58 weeks
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/43 • 58 weeks
|
6.2%
2/32 • Number of events 2 • 58 weeks
|
16.7%
2/12 • Number of events 2 • 58 weeks
|
7.0%
3/43 • Number of events 3 • 58 weeks
|
Additional Information
Michelle Landolfi, Senior Director, Regulatory Affairs
Impax Laboratories, Inc.
Phone: (510) 240-6496
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place