Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced PD - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 8, 2006

Last Updated Date

May 7, 2009

Start Date ^†

February 2008

Current Primary Outcome Measures ^†

Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00335153 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

mean daily "off" time (hours), UPDRS, CGI-I, PDQ‑39 and EQ-5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced PD

Official Title ^†

Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor-Fluctuations

Brief Summary

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in subjects with advanced Parkinson's Disease (PD) and severe motor-fluctuations

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Advanced Parkinson's Disease

Intervention ^†

Drug: Levodopa-Carbidopa intestinal gel
Device: CADD-Legacy® 1400

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

250

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Idiopathic parkinson's disease(PD)according to UKPDS Brain Bank Criteria;
Levodopa-responsive with severe motor fluctuations;
Recognizable off and on state (motor fluctuations) confirmed by diary

Exclusion Criteria:

Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism;
Undergone surgery for the treatment of PD;
Contraindications to levodopa (such as narrow angle glaucoma)

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Stephani Wilford

stephani.wilford@solvay.com

Location Countries ^†

United States, Australia, Czech Republic, Finland, Germany, Italy, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Spain, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00335153

Responsible Party

Stephani Wilford, Solvay Pharmaceuticals

Secondary IDs ^††

2006-005186-18

Study Sponsor ^†

Solvay Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.