Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
Information source: Abbott
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Parkinson's Disease
Intervention: levodopa-carbidopa intestinal gel active and placebo capsules (Drug); levodopa-carbidopa capsules active and placebo gel (Drug); CADD-Legacy® 1400 ambulatory infusion pump (Device)
Phase: Phase 3
Status: Recruiting
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Janet Benesh, Study Director, Affiliation: Abbott
Overall contact:
Wil Cramer, MS, Phone: 847-937-9199, Email: wil.cramer@abbott.com
Summary
The primary objective of this study will be to demonstrate the superiority of levodopa -
carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12
weeks. The study duration is 4 months.
Clinical Details
Official title: A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To evaluate a difference between levodopa-carbidopa intestinal gel and active control in the change from baseline and mean daily 'off' time (hours)
Secondary outcome: To evaluate on time without troublesome dyskinesia, PDQ-39, UPDRS, caregiver burden
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
- Idiopathic parkinson's disease(PD)according to UKPDS Brain Bank Criteria;
levodopa-responsive and subjects demonstrate some identifiable 'on response' established
by observation by investigator and demonstrate sever motor fluctuations in spite of
individually optimized treatment and where therapy options are indicated
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, subjects with any neurological deficit that may
interfere with the study assessments
Locations and Contacts
Wil Cramer, MS, Phone: 847-937-9199, Email: wil.cramer@abbott.com
Site Reference ID/Investigator# 44970, Bochum 44791, Germany; Completed
Site Reference ID/Investigator# 44969, Bochum 44791, Germany; Withdrawn
Site Reference ID/Investigator# 44971, Bremerhaven 27574, Germany; Completed
Site Reference ID/Investigator# 44973, Dresden 01307, Germany; Completed
Site Reference ID/Investigator# 44965, Hannover 30625, Germany; Completed
Site Reference ID/Investigator# 44964, Kiel 24105, Germany; Completed
Site Reference ID/Investigator# 44966, Marburg 35033, Germany; Completed
Site Reference ID/Investigator# 44968, Tuebingen 72076, Germany; Active, not recruiting
Site Reference ID/Investigator# 45719, Los Angeles, California 90033, United States; Recruiting
Site Reference ID/Investigator# 45719, Principal Investigator
Site Reference ID/Investigator# 45718, Englewood, Colorado 80113, United States; Recruiting
Site Reference ID/Investigator# 45718, Principal Investigator
Site Reference ID/Investigator# 45722, Washington, District of Columbia 20007, United States; Recruiting
Site Reference ID/Investigator# 45722, Principal Investigator
Site Reference ID/Investigator# 45721, Bradenton, Florida 34205, United States; Recruiting
Site Reference ID/Investigator# 45721, Principal Investigator
Site Reference ID/Investigator# 45705, Gainesville, Florida 32610, United States; Recruiting
Site Reference ID/Investigator# 45705, Principal Investigator
Site Reference ID/Investigator# 45710, Tampa, Florida 33606, United States; Not yet recruiting
Site Reference ID/Investigator# 45710, Principal Investigator
Site Reference ID/Investigator# 45742, Baltimore, Maryland 21287, United States; Withdrawn
Site Reference ID/Investigator# 45740, Baltimore, Maryland 21201, United States; Recruiting
Site Reference ID/Investigator# 45740, Principal Investigator
Site Reference ID/Investigator# 45739, St. Louis, Missouri 63110, United States; Recruiting
Site Reference ID/Investigator# 45739, Principal Investigator
Site Reference ID/Investigator# 45738, Manhasset, New York 11030, United States; Withdrawn
Site Reference ID/Investigator# 45703, Burlington, Vermont 05405, United States; Recruiting
Site Reference ID/Investigator# 45703, Principal Investigator
Additional Information
Starting date: January 2009
Last updated: August 26, 2011
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