Conditions: Parkinson's Disease
Keywords: motor Symptoms efficacy IPX066 Parkinson's Disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 617
Healthy volunteers: no

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.

Arms:
arm 1: 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.

Interventions: intervention 1: IPX066 95 mg intervention 2: IPX066 145 mg intervention 3: IPX066 195 mg intervention 4: IPX066 245 mg
Intervention descriptions: intervention 1: 23.75 - 95 mg CD-LD capsules intervention 2: 36.25 - 145 mg CD-LD capsules intervention 3: 48.75 - 195 mg CD-LD capsules intervention 4: 61.25 - 245 mg CD-LD capsules

Protocol document: