Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact (DAPHNE)

AbbVie

Status and phase: Completed; Phase 4

Conditions: Advanced Idiopathic Parkinson's Disease

Treatments: Device: CADD-Legacy® 1400 ambulatory infusion pump; Device: jejunal extension tube (J-tube); Drug: Levodopa-carbidopa intestinal gel (LCIG); Device: percutaneous endoscopic gastrostomy tube (PEG tube)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141518

2005-002654-21 (EudraCT Number)

S187.4.001

Details and patient eligibility

About

The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about one-third were Duodopa-naïve prior to the start of the study.

Enrollment: 77 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced idiopathic Parkinson's disease

Exclusion criteria

• Other diseases which might influence compliance or participation in the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

77 participants in 3 patient groups

Duodopa Naïve

Experimental group

Description:

Duodopa-naïve participants titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.

Treatment:

Device: percutaneous endoscopic gastrostomy tube (PEG tube)

Drug: Levodopa-carbidopa intestinal gel (LCIG)

Device: CADD-Legacy® 1400 ambulatory infusion pump

Device: jejunal extension tube (J-tube)

Duodopa Non-naïve < 2 Years

Experimental group

Description:

Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.

Treatment:

Device: percutaneous endoscopic gastrostomy tube (PEG tube)

Drug: Levodopa-carbidopa intestinal gel (LCIG)

Device: CADD-Legacy® 1400 ambulatory infusion pump

Device: jejunal extension tube (J-tube)

Duodopa Non-naïve ≥ 2 years

Experimental group

Description:

Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.

Treatment:

Device: percutaneous endoscopic gastrostomy tube (PEG tube)

Drug: Levodopa-carbidopa intestinal gel (LCIG)

Device: CADD-Legacy® 1400 ambulatory infusion pump

Device: jejunal extension tube (J-tube)