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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2009-017182-38-LT
Date of registration:	26/04/2010
Prospective Registration:	Yes
Primary sponsor:	Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)
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:	10/07/2010
Target sample size:	500
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017182-38
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Estonia	Germany	Latvia	Lithuania	Poland	Spain

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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:
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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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
Concentration number: 23.75-
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 95-

Product Name: IPX066
Product Code: IPX066-145
Pharmaceutical Form: Capsule*
INN or Proposed INN: CARBIDOPA
CAS Number: 38821-49-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 36.25-
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 145-

Product Name: IPX066
Product Code: IPX066-195
Pharmaceutical Form: Capsule*
INN or Proposed INN: CARBIDOPA
CAS Number: 38821-49-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48.75-
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 195-

Product Name: IPX066
Product Code: IPX066-245
Pharmaceutical Form: Capsule*
INN or Proposed INN: CARBIDOPA
CAS Number: 38821-49-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 61.25-
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 245-

Primary Outcome(s)

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).

Secondary Outcome(s)

Secondary ID(s)

2009-017182-38-EE

IPX066-B09-03

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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