Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects

• Conditions: Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.; MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2006-000578-53-DE
• Lead Sponsor: Abbott Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-30
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

In order to be eligible to participate in this study, subjects must meet the following criteria:
1. Completion of 12 weeks of double-blind treatment in either Study S187.3.001 or S187.3.002 and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG. No minimum Off time is required based on the
Parkinson's Disease Diary.
2. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
3. The subject must be willing to continue on treatment, and must continue to meet the inclusion criteria for the preceding study (Study S187.3.001 or S187.3.002), with the exception that ESC review and approval of eligibility is not required for
Study S187.3.003.
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

Subjects meeting any of the exclusion criteria listed below at Baseline must be excluded from participation in the study.
1. Subject may not be enrolled in another clinical trial.
2. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
3. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
4. Uncooperative attitude or reasonable likelihood for non-compliance with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified