Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD
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|ClinicalTrials.gov Identifier: NCT00660673|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2008
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Parkinson's Disease||Drug: Levodopa-carbidopa intestinal gel Device: CADD-Legacy® 1400 ambulatory infusion pump||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||262 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies|
|Actual Study Start Date :||November 13, 2009|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Levodopa-carbidopa intestinal gel
Drug: Levodopa-carbidopa intestinal gel
should be kept within a range of 0.5-10 ml/hour (10-200 mg levodopa/hour) and is usually 2-6 ml/hour (40-120 mg levodopa/hour);
Device: CADD-Legacy® 1400 ambulatory infusion pump
- Adverse Events [ Time Frame: Approximately 10 years, dependent on commercial availability of levodopa-carbidopa intestinal gel in each country ]The number of participants with adverse events.
- Long Term Safety and Maintenance of Efficacy [ Time Frame: Approximately 10 years, dependent on commercial availability of levodopa-carbidopa intestinal gel in each country ]
Long term safety will be assessed by evaluating complications of the infusion device, Columbia-Suicide Severity Rating Scale (C-SSRS), and Minnesota Impulsive Disorders Interview (MIDI).
Maintenance of efficacy will be assessed using data collected from US subjects by evaluating the mean change from baseline in the following: Off time, On time with troublesome dyskinesia and On time without troublesome dyskinesia as measured by the Parkinson's Disease Diary; UPDRS total score, Parts I, II, III and IV scores; and dyskinesia item score PDQ-39 summary index and domain scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660673
|Study Director:||AbbVie Inc.||AbbVie|