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Dopamine Agonist

A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 26

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a liquid form of the drug carbidopa/levodopa (LCIG) is more effective than the standard pill form of the drug (OMT) in reducing symptoms of non-motor fluctuations (NMS) in patients with Parkinson's disease (PD).

Eligible Conditions

Parkinson's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline to Week 26 in the Modified PDSS-2 Total Score

Change From Baseline to Week 26 in the NMSS Total Score

Secondary study objectives

Change From Baseline at Week 26 in Geriatric Depression Scale (GDS-15) Score

Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score

Change From Baseline at Week 26 in Parkinson's Anxiety Scale (PAS) Total Score

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Levodopa-Carbidopa Intestinal Gel (LCIG)Experimental Treatment3 Interventions

Participants randomized to LCIG at an individually optimized dose (after NJ and/or PEG-J placement), in accordance with the LCIG approved product label for countries participating in the study. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion is expected to run over a period of 16 consecutive hours each day. Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG.

Group II: Optimized Medical Treatment (OMT)Active Control4 Interventions

Participants randomized to continue OMT remain on their current optimized regimen. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

2015

Completed Phase 3

~90

Levodopa-Carbidopa Intestinal Gel

2013

Completed Phase 3

~130