Trial Outcomes & Findings for A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD). (NCT NCT00974974)
NCT ID: NCT00974974
Last Updated: 2020-08-11
Results Overview
Percentage of "off" time during waking hours at end of study is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
471 participants
Primary outcome timeframe
22 weeks
Results posted on
2020-08-11
Participant Flow
Study period was form September 29, 2009 to January 19, 2011.
Prior to randomization, subjects needed to complete a 3-week dose adjustment of IR CD-LD followed by 6-week dose conversion to IPX066.
Participant milestones
| Measure |
IPX066
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
|
IR CD-LD (Active Comparator)
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
|
|---|---|---|
|
IR CD-LD Dose Adjustment
STARTED
|
0
|
471
|
|
IR CD-LD Dose Adjustment
COMPLETED
|
0
|
450
|
|
IR CD-LD Dose Adjustment
NOT COMPLETED
|
0
|
21
|
|
IPX066 Dose Conversion
STARTED
|
450
|
0
|
|
IPX066 Dose Conversion
COMPLETED
|
393
|
0
|
|
IPX066 Dose Conversion
NOT COMPLETED
|
57
|
0
|
|
Maintenance - Double Blind Treatment
STARTED
|
201
|
192
|
|
Maintenance - Double Blind Treatment
COMPLETED
|
186
|
182
|
|
Maintenance - Double Blind Treatment
NOT COMPLETED
|
15
|
10
|
Reasons for withdrawal
| Measure |
IPX066
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
|
IR CD-LD (Active Comparator)
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
|
|---|---|---|
|
IR CD-LD Dose Adjustment
Adverse Event
|
0
|
3
|
|
IR CD-LD Dose Adjustment
Protocol Violation
|
0
|
1
|
|
IR CD-LD Dose Adjustment
Noncompliance with study drug
|
0
|
1
|
|
IR CD-LD Dose Adjustment
Withdrawal by Subject
|
0
|
7
|
|
IR CD-LD Dose Adjustment
Various
|
0
|
9
|
|
IPX066 Dose Conversion
Adverse Event
|
23
|
0
|
|
IPX066 Dose Conversion
Death
|
2
|
0
|
|
IPX066 Dose Conversion
Lack of Efficacy
|
13
|
0
|
|
IPX066 Dose Conversion
Withdrawal by Subject
|
12
|
0
|
|
IPX066 Dose Conversion
Various
|
3
|
0
|
|
IPX066 Dose Conversion
Protocol Violation
|
4
|
0
|
|
Maintenance - Double Blind Treatment
Adverse Event
|
3
|
3
|
|
Maintenance - Double Blind Treatment
Protocol Violation
|
1
|
1
|
|
Maintenance - Double Blind Treatment
Noncompliance with study drug
|
0
|
1
|
|
Maintenance - Double Blind Treatment
Lack of Efficacy
|
2
|
2
|
|
Maintenance - Double Blind Treatment
Lost to Follow-up
|
0
|
1
|
|
Maintenance - Double Blind Treatment
Withdrawal by Subject
|
5
|
2
|
|
Maintenance - Double Blind Treatment
Various
|
4
|
0
|
Baseline Characteristics
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
Baseline characteristics by cohort
| Measure |
IPX066
n=201 Participants
Investigational product IPX066
|
Carbidopa-Levodopa
n=192 Participants
Immediate-release carbidopa and levodopa
|
Total
n=393 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
63.4 years
STANDARD_DEVIATION 8.8 • n=107 Participants
|
63.2 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
254 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
192 Participants
n=99 Participants
|
182 Participants
n=107 Participants
|
374 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
196 participants
n=99 Participants
|
186 participants
n=107 Participants
|
382 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=99 Participants
|
93 participants
n=107 Participants
|
191 participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
37 participants
n=99 Participants
|
38 participants
n=107 Participants
|
75 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
34 participants
n=99 Participants
|
33 participants
n=107 Participants
|
67 participants
n=206 Participants
|
|
Region of Enrollment
France
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 22 weeksPopulation: All randomized subjects
Percentage of "off" time during waking hours at end of study is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."
Outcome measures
| Measure |
IPX066
n=201 Participants
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
|
IR CD-LD (Active Comparator)
n=192 Participants
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
|
|---|---|---|
|
Percentage of "Off" Time During Waking Hours at End of Study
|
23.82 percentage
Standard Deviation 14.91
|
29.79 percentage
Standard Deviation 15.81
|
SECONDARY outcome
Timeframe: 22 weeksPopulation: All randomized subjects
"Off" time hours is measured by using the Parkinson's disease diary. "Off" time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."
Outcome measures
| Measure |
IPX066
n=201 Participants
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
|
IR CD-LD (Active Comparator)
n=192 Participants
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
|
|---|---|---|
|
"Off" Time
|
3.87 hours
Standard Deviation 2.46
|
4.88 hours
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: 22 weeksPopulation: All randomized subjects
"On" time without troublesome dyskinesiais measured by using the Parkinson's disease diary. "On" time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living."
Outcome measures
| Measure |
IPX066
n=201 Participants
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
|
IR CD-LD (Active Comparator)
n=192 Participants
Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
|
|---|---|---|
|
"On" Time Without Troublesome Dyskinesia
|
11.84 hours
Standard Deviation 2.96
|
10.91 hours
Standard Deviation 2.82
|
Adverse Events
IPX066
Serious events: 11 serious events
Other events: 57 other events
Deaths: 0 deaths
Carbidopa-Levodopa
Serious events: 5 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IPX066
n=201 participants at risk
Investigational product IPX066
|
Carbidopa-Levodopa
n=192 participants at risk
Immediate-release carbidopa and levodopa
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/201 • 22 weeks
|
0.52%
1/192 • 22 weeks
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Gastrointestinal disorders
Volvulus
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
General disorders
Chest Pain
|
0.00%
0/201 • 22 weeks
|
0.52%
1/192 • 22 weeks
|
|
General disorders
Non-cardiac Chest Pain
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/201 • 22 weeks
|
0.52%
1/192 • 22 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/201 • 22 weeks
|
0.52%
1/192 • 22 weeks
|
|
Injury, poisoning and procedural complications
Subdural Hematoma
|
0.00%
0/201 • 22 weeks
|
0.52%
1/192 • 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/201 • 22 weeks
|
0.52%
1/192 • 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine Carcinoma of the Skin
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Nervous system disorders
Cerebral Infarction
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Psychiatric disorders
Acute Psychosis
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Psychiatric disorders
Anxiety
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/201 • 22 weeks
|
0.52%
1/192 • 22 weeks
|
|
Surgical and medical procedures
Toe Amputation
|
0.00%
0/201 • 22 weeks
|
0.52%
1/192 • 22 weeks
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.50%
1/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
Other adverse events
| Measure |
IPX066
n=201 participants at risk
Investigational product IPX066
|
Carbidopa-Levodopa
n=192 participants at risk
Immediate-release carbidopa and levodopa
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
3.5%
7/201 • 22 weeks
|
1.0%
2/192 • 22 weeks
|
|
Gastrointestinal disorders
nausea
|
3.0%
6/201 • 22 weeks
|
1.6%
3/192 • 22 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
6/201 • 22 weeks
|
2.1%
4/192 • 22 weeks
|
|
Nervous system disorders
Dizziness
|
2.5%
5/201 • 22 weeks
|
1.0%
2/192 • 22 weeks
|
|
Nervous system disorders
Dyskinesia
|
2.5%
5/201 • 22 weeks
|
1.0%
2/192 • 22 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
4/201 • 22 weeks
|
0.52%
1/192 • 22 weeks
|
|
General disorders
Oedema Peripheral
|
2.0%
4/201 • 22 weeks
|
2.1%
4/192 • 22 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.0%
4/201 • 22 weeks
|
2.1%
4/192 • 22 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
2.0%
4/201 • 22 weeks
|
2.1%
4/192 • 22 weeks
|
|
Psychiatric disorders
Sleep Disorder
|
2.0%
4/201 • 22 weeks
|
2.1%
4/192 • 22 weeks
|
|
Investigations
Weight Decreased
|
2.0%
4/201 • 22 weeks
|
0.00%
0/192 • 22 weeks
|
|
Infections and infestations
Bronchitis
|
1.5%
3/201 • 22 weeks
|
1.0%
2/192 • 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.5%
3/201 • 22 weeks
|
2.1%
4/192 • 22 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.00%
2/201 • 22 weeks
|
1.0%
2/192 • 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.00%
2/201 • 22 weeks
|
2.1%
4/192 • 22 weeks
|
|
Nervous system disorders
Headache
|
1.00%
2/201 • 22 weeks
|
1.6%
3/192 • 22 weeks
|
|
Nervous system disorders
On and Off Phenomenon
|
1.00%
2/201 • 22 weeks
|
1.0%
2/192 • 22 weeks
|
|
Psychiatric disorders
Anxiety
|
1.00%
2/201 • 22 weeks
|
1.6%
3/192 • 22 weeks
|
|
Vascular disorders
Orthostatic Hypotension
|
1.00%
2/201 • 22 weeks
|
1.0%
2/192 • 22 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/201 • 22 weeks
|
2.1%
4/192 • 22 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.50%
1/201 • 22 weeks
|
1.6%
3/192 • 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.50%
1/201 • 22 weeks
|
1.6%
3/192 • 22 weeks
|
|
Psychiatric disorders
Depression
|
0.50%
1/201 • 22 weeks
|
2.6%
5/192 • 22 weeks
|
|
General disorders
Gait Disturbance
|
0.00%
0/201 • 22 weeks
|
1.6%
3/192 • 22 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/201 • 22 weeks
|
1.6%
3/192 • 22 weeks
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/201 • 22 weeks
|
1.0%
2/192 • 22 weeks
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/201 • 22 weeks
|
1.0%
2/192 • 22 weeks
|
Additional Information
Michelle Landolfi, Director, Regulatory Affairs
Impax Laboratories, Inc.
Phone: 510-240-6402
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