An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017182-38-LT

Enrollment

500

Registered

2010-04-26

Start date

2010-07-10

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1 Level: LLT Classification code 10061536 Term: Parkinson's disease

Interventions

Product Name: IPX066 Product Code: IPX066-95 Pharmaceutical Form: Capsule* INN or Proposed INN: CARBIDOPA CAS Number: 38821-49-7 Concentration unit: mg milligram(s) Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to evaluate the long-term safety and clinical utility of IPX066 in subjects with Parkinson´s disease.;Secondary Objective: none;Primary end point(s): Safety (assessed by vital signs, laboratory results, ECGs, adverse events); Clinical Utility (assessed by UPDRS, PDQ-39, PGI); health outcomes (assessed by EQ-5D, SF-36).	—

Countries

Estonia, Germany, Latvia, Lithuania, Poland, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026