Trial Outcomes & Findings for An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease (NCT NCT01096186)

Last Updated: 2019-11-08

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 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

617 participants

Primary outcome timeframe

9 months

Results posted on

2019-11-08

Participant Flow

Study dates March 25, 2010 through October 19, 2011 Completion of previous trial a requirement

Participant milestones

Participant milestones
Measure	IPX066 Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Overall Study STARTED	617
Overall Study COMPLETED	567
Overall Study NOT COMPLETED	50

Reasons for withdrawal

Reasons for withdrawal
Measure	IPX066 Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Overall Study Adverse Event	16
Overall Study Death	4
Overall Study Lack of Efficacy	4
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	22
Overall Study Physician Decision	1
Overall Study Noncompliance with study drug	1

Baseline Characteristics

An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IPX066 n=617 Participants Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Age, Continuous	64.1 years STANDARD_DEVIATION 9.23 • n=5 Participants
Sex: Female, Male Female	234 Participants n=5 Participants
Sex: Female, Male Male	383 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	582 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants
Race/Ethnicity, Customized White	608 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants
Region of Enrollment Canada	48 participants n=5 Participants
Region of Enrollment Latvia	2 participants n=5 Participants
Region of Enrollment Romania	43 participants n=5 Participants
Region of Enrollment United States	260 participants n=5 Participants
Region of Enrollment Ukraine	165 participants n=5 Participants
Region of Enrollment Poland	50 participants n=5 Participants
Region of Enrollment Lithuania	18 participants n=5 Participants
Region of Enrollment Germany	19 participants n=5 Participants
Region of Enrollment Estonia	3 participants n=5 Participants
Region of Enrollment Spain	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: All enrolled subjects with available data

Outcome measures

Outcome measures
Measure	IPX066 n=567 Participants Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III	26.4 units on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: 9 months

Population: All enrolled subjects with available data

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

Outcome measures

Outcome measures
Measure	IPX066 n=567 Participants Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Total UPDRS Parts I-IV	30.5 units on a scale Standard Deviation 14.67

SECONDARY outcome

Timeframe: 9 months

Population: All enrolled subjects with available data

Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale. Patient Global Impression 0-7 - higher value indicates increased improvement from study start

Outcome measures

Outcome measures
Measure	IPX066 n=567 Participants Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Patient Global Impression (PGI)	5.4 units on a scale Standard Deviation 1.16

Adverse Events

IPX066

Serious events: 43 serious events

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IPX066 n=617 participants at risk Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Cardiac disorders Atrial fibrillation	0.32% 2/617 • Screening through 9 months
Cardiac disorders Atrioventricular block complete	0.16% 1/617 • Screening through 9 months
Cardiac disorders Sick sinus syndrome	0.16% 1/617 • Screening through 9 months
Cardiac disorders Sinus bradycardia	0.16% 1/617 • Screening through 9 months
Gastrointestinal disorders Gastritis	0.32% 2/617 • Screening through 9 months
Gastrointestinal disorders Gastrointestinal haemorrhage	0.16% 1/617 • Screening through 9 months
Gastrointestinal disorders Ileus	0.16% 1/617 • Screening through 9 months
Gastrointestinal disorders Inflammatory bowel disease	0.16% 1/617 • Screening through 9 months
Gastrointestinal disorders Pancreatitis haemorrhagic	0.16% 1/617 • Screening through 9 months
Gastrointestinal disorders Small intestinal obstruction	0.16% 1/617 • Screening through 9 months
Gastrointestinal disorders Volvulus	0.16% 1/617 • Screening through 9 months
General disorders Death	0.16% 1/617 • Screening through 9 months
General disorders Non-cardiac chest pain	0.16% 1/617 • Screening through 9 months
Infections and infestations Cellulitis	0.16% 1/617 • Screening through 9 months
Infections and infestations Wound infection	0.16% 1/617 • Screening through 9 months
Injury, poisoning and procedural complications Concussion	0.16% 1/617 • Screening through 9 months
Injury, poisoning and procedural complications Fall	0.32% 2/617 • Screening through 9 months
Injury, poisoning and procedural complications Femoral neck fracture	0.49% 3/617 • Screening through 9 months
Injury, poisoning and procedural complications Femur facture	0.16% 1/617 • Screening through 9 months
Injury, poisoning and procedural complications Hip fracture	0.16% 1/617 • Screening through 9 months
Injury, poisoning and procedural complications Humerus fracture	0.16% 1/617 • Screening through 9 months
Injury, poisoning and procedural complications Scalpula fracture	0.16% 1/617 • Screening through 9 months
Metabolism and nutrition disorders Hyponatraemia	0.32% 2/617 • Screening through 9 months
Musculoskeletal and connective tissue disorders Back pain	0.16% 1/617 • Screening through 9 months
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.16% 1/617 • Screening through 9 months
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.16% 1/617 • Screening through 9 months
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.16% 1/617 • Screening through 9 months
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.32% 2/617 • Screening through 9 months
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.32% 2/617 • Screening through 9 months
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.16% 1/617 • Screening through 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.16% 1/617 • Screening through 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.16% 1/617 • Screening through 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.16% 1/617 • Screening through 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.16% 1/617 • Screening through 9 months
Nervous system disorders Cerebrovascular accident	0.16% 1/617 • Screening through 9 months
Nervous system disorders Convulsion	0.16% 1/617 • Screening through 9 months
Nervous system disorders Freezing phenomenon	0.16% 1/617 • Screening through 9 months
Nervous system disorders Haemorrhagic stroke	0.16% 1/617 • Screening through 9 months
Nervous system disorders IIIrd nerve paralysis	0.16% 1/617 • Screening through 9 months
Nervous system disorders Loss of consciousness	0.16% 1/617 • Screening through 9 months
Nervous system disorders Neuropathy	0.16% 1/617 • Screening through 9 months
Nervous system disorders Somnolence	0.16% 1/617 • Screening through 9 months
Nervous system disorders Syncope	0.16% 1/617 • Screening through 9 months
Psychiatric disorders Confusional state	0.16% 1/617 • Screening through 9 months
Psychiatric disorders Hallucination	0.16% 1/617 • Screening through 9 months
Psychiatric disorders Paranoia	0.16% 1/617 • Screening through 9 months
Renal and urinary disorders Calculus ureteric	0.16% 1/617 • Screening through 9 months
Renal and urinary disorders Renal failure	0.16% 1/617 • Screening through 9 months
Reproductive system and breast disorders Pelvic prolapse	0.16% 1/617 • Screening through 9 months
Surgical and medical procedures Knee arthroplasty	0.16% 1/617 • Screening through 9 months
Surgical and medical procedures Toe operation	0.16% 1/617 • Screening through 9 months
Vascular disorders Hypertension	0.16% 1/617 • Screening through 9 months
Vascular disorders Hypotension	0.16% 1/617 • Screening through 9 months

Other adverse events

Other adverse events
Measure	IPX066 n=617 participants at risk Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Gastrointestinal disorders Nausea	5.2% 32/617 • Screening through 9 months
Psychiatric disorders Insomnia	5.8% 36/617 • Screening through 9 months
Injury, poisoning and procedural complications Fall	5.3% 33/617 • Screening through 9 months
Nervous system disorders Dyskinesia	5.5% 34/617 • Screening through 9 months

Additional Information

Daven Mody, PharmD, MBA, Director, Regulatory Affairs

Impax Laboratories, Inc.

Phone: 510-240-6073

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