Levodopa/Carbidopa: Duodopa

CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.

{m} Entries

Phase
Study Indication or Disease
Study Name
S187.3.002 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 3 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
M12-921 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 3 An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects with Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment with Available Anti-Parkinsonian Medication
P13-895 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease PMOS Global REsponsE during iNFusIon of a gEl with LevoDopa/carbidopa (GREENFIELD)
S187.3.003 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 3 Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects
P13-893 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease PMOS A post marketing observational study of activities of daily living in advanced Parkinson's disease patients with early troublesome motor fluctuations and treated with Duodopa - a multi-country study - MONOTREAT
S187.3.004 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 3 An Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease Medications
P14-335 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease PMOS Study On Patient- And Caregiver-Reported Symptoms And Outcomes With Levodopa/Carbidopa Intestinal Gel For The Treatment Of Advanced Parkinson’s Disease.
P14-000 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease PMOS Levodopa Carbidopa Intestinal Gel Home Titration using Telemedicine: Evaluation of use of Resources.
S187.3.001 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 3 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
M12-925 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 2 An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
M12-920 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 3 An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease
S187.4.004 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease PMOS Global Long-Term Registry on Efficacy and Safety of DUODOPA in Patients with Advanced Parkinson's Disease in Routine Care (GLORIA)
S187.4.001 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 4 A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia
S187.1.002 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 1 A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease
P16-831 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease PMOS COSMOS - COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel
M15-535 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 3 An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease
M12-923 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease Phase 3 An Open-Label Two-Part Extension Study Assessing Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects with Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment with Available Anti-Parkinsonian Medications
P14-322 AbbVie_IU_icons_outlined_v3 Advanced Parkinson's Disease PMOS Health related quality of life in LCIG patients and LCIG eligible patients continuing oral therapy. A multicenter Post Marketing Observational Study for LCIG in Germany and Switzerland – BALANCE