Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

AbbVie

Status and phase: Completed; Phase 3

Conditions: Advanced Parkinson's Disease

Treatments: Device: CADD-Legacy® 1400 ambulatory infusion pump; Drug: Levodopa-Carbidopa Intestinal Gel (LCIG); Device: Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00660673

S187.3.005

2008-001329-33 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 [NCT00360568] or Study S187.3.004 [NCT00335153]).

Enrollment: 262 patients

Sex

Ages: 30 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG.
• For Canada, participants will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
• The participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. Consenting will be performed according to local regulations.

Exclusion criteria

• Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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262 participants in 1 patient group

Levodopa-Carbidopa Intestinal Gel

Experimental group

Description:

Initial dosing is based on the dosing regimen that the participant received during the previous LCIG study. Dosing is individually optimized and can be adjusted at any time during the study as clinically indicated. The total dose/day of LCIG is composed of 3 individually adjusted doses. The morning dose is administered as a bolus infusion, usually 5 to 10 mL (100 to 200 mg levodopa). The maintenance dose is adjustable in steps of 2 mg/hour (0.1 mL/hour), within a range of 1 to 10 mL/hour (20 to 200 mg levodopa/hour) and is usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour). Participants will be allowed to self-administer extra doses of LCIG to address immediate medical needs, normally 0.5 to 2.0 mL. Participants will receive LCIG until it is commercially available.

Treatment:

Device: Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)

Drug: Levodopa-Carbidopa Intestinal Gel (LCIG)

Device: CADD-Legacy® 1400 ambulatory infusion pump