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

Impax Laboratories

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: IPX066 195 mg; Drug: IPX066 145 mg; Drug: IPX066 95 mg; Drug: IPX066 245 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096186

IPX066-B09-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 617 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Each subject must meet the following inclusion criteria in order to be enrolled in the study:

  1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.
  2. 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:

  1. Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
  2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
  3. 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).
  4. In the opinion of the Investigator, should not participate in the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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617 participants in 1 patient group

Open Label IPX066

Other group

Description:

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.

Treatment:

Drug: IPX066 245 mg

Drug: IPX066 95 mg

Drug: IPX066 145 mg

Drug: IPX066 195 mg