Conditions: Dyskinesias Parkinson's Disease Severe Motor Fluctuations
Keywords: carbidopa severe motor fluctuations intestinal gel levodopa efficacy levodopa carbidopa intestinal gel dyskinesia Parkinson's Disease Duodopa levodopa-carbidopa DUOPA
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 62
Healthy volunteers: no

Brief summary:
Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

Detailed description:
Study S187.3.003 (NCT00360568) is a Phase 3, 12-month, open-label, multicenter continuation treatment study of the safety, tolerability, and efficacy of levodopa-carbidopa intestinal gel (LCIG) in the treatment of participants with levodopa-responsive Parkinson's disease (PD) with persistent motor fluctuations despite optimized treatment with available PD medications. All participants received LCIG.

Only participants who completed 12 weeks of double-blind, double-dummy treatment in Study S187.3.001 or S187.3.002 (NCT00357994/ NCT00660387) qualified for enrollment in this 12-month continuation treatment study.

Arms:
arm 1: All participants received LCIG, delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks).

Starting dose of LCIG was based on the participant's optimized oral levodopa-carbidopa dose that the subject was receiving just prior to randomization in Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of either of these 2 previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

Interventions: intervention 1: Levodopa-carbidopa intestinal gel intervention 2: CADD-Legacy® 1400 ambulatory infusion pump intervention 3: PEG tube intervention 4: J-tube
Intervention descriptions: intervention 1: Infusion 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). intervention 2: None intervention 3: percutaneous endoscopic gastrostomy tube intervention 4: jejunal tube

Protocol document: