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Dopamine Agonist

Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube for Parkinson's Disease

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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Nasojejunal (NJ) tube

2015

Completed Phase 3

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

501,016 Total Patients Enrolled

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

101,468 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the primary reasons that patients receive a Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube?

"A PEG-J tube is most often used in cases of manganese intoxication, but it has also been successfully used to treat advanced motor fluctuations, restless legs syndrome (rls), and carbon monoxide intoxication."

Answered by AI

Are there historical examples of Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube?

"As of now, there are 17 ongoing clinical trials related to Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube. Out of these 17 trials, 5 are in Phase 3. It's worth noting that while a majority of these trials are based in Austin, Texas, there are 291 locations worldwide running these studies."

Answered by AI

What risks are associated with Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube?

"There is some data supporting efficacy and multiple rounds of data supporting safety for Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube, thus it received a score of 3."

Answered by AI

Why did researchers design this clinical trial and what are they hoping to learn from it?

"The primary outcome of this trial, which will be assessed over a Baseline, Week 26 time frame, is to Change From Baseline to Week 26 in the NMSS Total Score. Secondary outcomes include Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score, Patient Global Impression of Change (PGIC) Final Score, and Change From Baseline to Week 26 in the NMSS Domain Scores."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2015. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02549092.