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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

Detailed Description
-----------------
IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066: IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease) IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa - Levodopa) IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease) All participants will be given IPX066 for 9 months.

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

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: IPX066 95 mg
* Drug: IPX066 145 mg
* Drug: IPX066 195 mg
* Drug: IPX066 245 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each subject must meet the following inclusion criteria in order to be enrolled in the study: Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy. Exclusion Criteria: Each subject must be free of the following exclusion criteria in order to be enrolled in the study: Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation. Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline). In the opinion of the Investigator, should not participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open Label IPX066<br>Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator. | Drug: IPX066 95 mg<br>* 23.75 - 95 mg CD-LD capsules<br>* Other names: CD-LD ER 95 mg;Drug: IPX066 145 mg<br>* 36.25 - 145 mg CD-LD capsules<br>* Other names: CD-LD ER 145 mg;Drug: IPX066 195 mg<br>* 48.75 - 195 mg CD-LD capsules<br>* Other names: CD-LD ER195 mg;Drug: IPX066 245 mg<br>* 61.25 - 245 mg CD-LD capsules<br>* Other names: CD-LD ER 245 mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III | 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 | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total UPDRS Parts I-IV | 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 | 9 months | 
| Patient Global Impression (PGI) | Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale. Patient Global Impression 0-7 - higher value indicates increased improvement from study start | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
motor Symptoms, efficacy, IPX066, Parkinson's Disease