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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01096186
• Date of registration: 25/03/2010
• Prospective Registration: No
• Primary sponsor: Impax Laboratories, LLC
• Public title: An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
• Scientific title: An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
• Date of first enrolment: March 2010
• Target sample size: 617
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01096186
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, Estonia, Germany, Latvia, Lithuania, Poland, Romania, Spain, Ukraine, United States

Contacts

• Name: Impax Study Director
• Affiliation: Impax Laboratories, LLC

Key inclusion & exclusion criteria

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.



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: IPX066 95 mg

Drug: IPX066 245 mg

Drug: IPX066 195 mg

Drug: IPX066 145 mg

Primary Outcome(s)

Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III [Time Frame: 9 months]

Secondary Outcome(s)

Patient Global Impression (PGI) [Time Frame: 9 months]

Total UPDRS Parts I-IV [Time Frame: 9 months]

Secondary ID(s)

IPX066-B09-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/03/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01096186