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

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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)

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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