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Trial record 99 of 158 for:    genetics AND Parkinson's disease

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

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ClinicalTrials.gov Identifier: NCT01096186
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : March 3, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: IPX066 95 mg
Drug: IPX066 145 mg
Drug: IPX066 195 mg
Drug: IPX066 245 mg
Enrollment 617
Recruitment Details Study dates March 25, 2010 through October 19, 2011 Completion of previous trial a requirement
Pre-assignment Details  
Arm/Group Title IPX066
Hide Arm/Group Description Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Period Title: Overall Study
Started 617
Completed 567
Not Completed 50
Reason Not Completed
Adverse Event             16
Death             4
Lack of Efficacy             4
Lost to Follow-up             2
Withdrawal by Subject             22
Physician Decision             1
Noncompliance with study drug             1
Arm/Group Title IPX066
Hide Arm/Group Description Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Overall Number of Baseline Participants 617
Hide Baseline Analysis Population Description
All enrolled subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 617 participants
64.1  (9.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 617 participants
Female
234
  37.9%
Male
383
  62.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 617 participants
Hispanic or Latino
20
   3.2%
Not Hispanic or Latino
582
  94.3%
Unknown or Not Reported
15
   2.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 617 participants
White 608
Black or African American 3
Asian 3
Other 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 617 participants
Canada 48
Latvia 2
Romania 43
United States 260
Ukraine 165
Poland 50
Lithuania 18
Germany 19
Estonia 3
Spain 9
1.Primary Outcome
Title Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects with available data
Arm/Group Title IPX066
Hide Arm/Group Description:
Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Overall Number of Participants Analyzed 567
Mean (Standard Deviation)
Unit of Measure: units on a scale
26.4  (13.3)
2.Secondary Outcome
Title Total UPDRS Parts I-IV
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects with available data
Arm/Group Title IPX066
Hide Arm/Group Description:
Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Overall Number of Participants Analyzed 567
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.5  (14.67)
3.Secondary Outcome
Title Patient Global Impression (PGI)
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects with available data
Arm/Group Title IPX066
Hide Arm/Group Description:
Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
Overall Number of Participants Analyzed 567
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.4  (1.16)
Time Frame Screening through 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IPX066
Hide Arm/Group Description Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
All-Cause Mortality
IPX066
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IPX066
Affected / at Risk (%)
Total   43/617 (6.97%) 
Cardiac disorders   
Atrial fibrillation * 1  2/617 (0.32%) 
Atrioventricular block complete * 1  1/617 (0.16%) 
Sick sinus syndrome * 1  1/617 (0.16%) 
Sinus bradycardia * 1  1/617 (0.16%) 
Gastrointestinal disorders   
Gastritis * 1  2/617 (0.32%) 
Gastrointestinal haemorrhage * 1  1/617 (0.16%) 
Ileus * 1  1/617 (0.16%) 
Inflammatory bowel disease * 1  1/617 (0.16%) 
Pancreatitis haemorrhagic * 1  1/617 (0.16%) 
Small intestinal obstruction * 1  1/617 (0.16%) 
Volvulus * 1  1/617 (0.16%) 
General disorders   
Death * 1  1/617 (0.16%) 
Non-cardiac chest pain * 1  1/617 (0.16%) 
Infections and infestations   
Cellulitis * 1  1/617 (0.16%) 
Wound infection * 1  1/617 (0.16%) 
Injury, poisoning and procedural complications   
Concussion * 1  1/617 (0.16%) 
Fall * 1  2/617 (0.32%) 
Femoral neck fracture * 1  3/617 (0.49%) 
Femur facture * 1  1/617 (0.16%) 
Hip fracture * 1  1/617 (0.16%) 
Humerus fracture * 1  1/617 (0.16%) 
Scalpula fracture * 1  1/617 (0.16%) 
Metabolism and nutrition disorders   
Hyponatraemia * 1  2/617 (0.32%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/617 (0.16%) 
Intervertebral disc compression * 1  1/617 (0.16%) 
Intervertebral disc degeneration * 1  1/617 (0.16%) 
Intervertebral disc disorder * 1  1/617 (0.16%) 
Spinal column stenosis * 1  2/617 (0.32%) 
Spinal osteoarthritis * 1  2/617 (0.32%) 
Spondylolisthesis * 1  1/617 (0.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer * 1  1/617 (0.16%) 
Chronic lymphocytic leukaemia * 1  1/617 (0.16%) 
Neuroendocrine carcinoma of the skin * 1  1/617 (0.16%) 
Prostate cancer * 1  1/617 (0.16%) 
Nervous system disorders   
Cerebrovascular accident * 1  1/617 (0.16%) 
Convulsion * 1  1/617 (0.16%) 
Freezing phenomenon * 1  1/617 (0.16%) 
Haemorrhagic stroke * 1  1/617 (0.16%) 
IIIrd nerve paralysis * 1  1/617 (0.16%) 
Loss of consciousness * 1  1/617 (0.16%) 
Neuropathy * 1  1/617 (0.16%) 
Somnolence * 1  1/617 (0.16%) 
Syncope * 1  1/617 (0.16%) 
Psychiatric disorders   
Confusional state * 1  1/617 (0.16%) 
Hallucination * 1  1/617 (0.16%) 
Paranoia * 1  1/617 (0.16%) 
Renal and urinary disorders   
Calculus ureteric * 1  1/617 (0.16%) 
Renal failure * 1  1/617 (0.16%) 
Reproductive system and breast disorders   
Pelvic prolapse * 1  1/617 (0.16%) 
Surgical and medical procedures   
Knee arthroplasty * 1  1/617 (0.16%) 
Toe operation * 1  1/617 (0.16%) 
Vascular disorders   
Hypertension * 1  1/617 (0.16%) 
Hypotension * 1  1/617 (0.16%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IPX066
Affected / at Risk (%)
Total   122/617 (19.77%) 
Gastrointestinal disorders   
Nausea * 1  32/617 (5.19%) 
Injury, poisoning and procedural complications   
Fall * 1  33/617 (5.35%) 
Nervous system disorders   
Dyskinesia * 1  34/617 (5.51%) 
Psychiatric disorders   
Insomnia * 1  36/617 (5.83%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of the results of the Study conducted at the Site shall not be made before the first multi-site publication by Sponsor.
Results Point of Contact
Name/Title: Daven Mody, PharmD, MBA, Director, Regulatory Affairs
Organization: Impax Laboratories, Inc.
Phone: 510-240-6073
Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01096186     History of Changes
Other Study ID Numbers: IPX066-B09-03
First Submitted: March 25, 2010
First Posted: March 31, 2010
Results First Submitted: December 9, 2015
Results First Posted: March 3, 2016
Last Update Posted: March 10, 2017