A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease

NCT01736176 | Completed Phase 3 Results

• 1 other identifier: M12-920
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate change in non-motor symptoms from baseline to Week 12 as measured by the Non-Motor Symptom Scale total score.

Conditions

Advanced Parkinson's Disease

Keywords

Safety and efficacy; Advanced Parkinson's disease; levodopa-carbidopa intestinal gel,; carbidopa; levodopa; Non-Motor Symptom Scale

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score

  The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms.

  Baseline and Week 12

Secondary Outcomes (37)

• Number of Participants Who Used Healthcare Resources During the First 4 Weeks

  Weeks 1-4

• Number of Participants With Adverse Events

  Weeks 1-4 and Overall (from Week 1 through 30 days after the end of the LCIG Treatment Period; median duration of LCIG device exposure was 428 days)

• Number of Participants Who Used Healthcare Resources Through Week 60

  Week 60

• Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score

  Baseline and Week 60

• Change From Baseline in NMSS Cardiovascular Domain Score

  Baseline and Week 12 and Week 60

Study Arms (1)

Levodopa-Carbidopa Intestinal Gel

EXPERIMENTAL

Participants had the PEG-J tube placement procedure performed on Study Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually. The starting total daily dose of LCIG was based solely on the daily dose of the oral levodopa taken immediately prior to Study Day 1 and was adjusted to obtain the optimal clinical response for the individual participant. Participants received treatment for up to 60 weeks; participants who completed their Week 60 visit before LCIG was commercially available had the option to extend their LCIG therapy, if in the opinion of the investigator, the participant would benefit from continued LCIG treatment.

Drug: Levodopa-Carbidopa Intestinal Gel; Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J); Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets

Interventions

Levodopa-Carbidopa Intestinal Gel DRUG

Levodopa-carbidopa intestinal gel (LCIG) for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa monohydrate (5 mg/mL) in an aqueous gel, administered continuously by a portable pump via a percutaneous endoscopic gastrojejunostomy (PEG-J) tube. The rate of LCIG infusion was expected to be within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances over a period of 16 consecutive hours.

Also known as: Duopa, Carbidopa-levodopa enteral suspension (CLES)

Levodopa-Carbidopa Intestinal Gel

Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J) PROCEDURE

Levodopa-Carbidopa Intestinal Gel

Levodopa-carbidopa Immediate Release (LC-IR) Tablets DRUG

After LCIG initiation, participants could take prescribed oral levodopa-carbidopa immediate or continuous release (i.e., oral LC prescribed by the investigator) for nighttime use.

Levodopa-Carbidopa Intestinal Gel

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
• Demonstrate persistent motor fluctuations in spite of individually optimized treatment
• Subject must experience a minimum of 3 hours "Off" time

You may not qualify if:

• Subject's PD diagnosis is unclear or there is a suspicion that the subject has a Parkinsonian syndrome such as secondary Parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndrome (e.g., Multiple System Atrophy, Progressive Supranuclear Palsy, Diffuse Lewy Body Disease, Corticobasilar Degeneration), or other neurodegenerative disease that might mimic the symptoms of PD.
• Subject has undergone neurosurgery for the treatment of Parkinson's disease
• Subject for whom the placement of a PEG-J tube for LCIG treatment is contraindicated or is considered a high risk for the PEG-J procedure according to the gastroenterology evaluation (e.g., pathological changes of the gastric wall, inability to bring the gastric wall and abdominal wall together, blood coagulation disorders, peritonitis, acute pancreatitis, paralytic ileus).

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (1)

• Standaert DG, Rodriguez RL, Slevin JT, Lobatz M, Eaton S, Chatamra K, Facheris MF, Hall C, Sail K, Jalundhwala YJ, Benesh J. Effect of Levodopa-carbidopa Intestinal Gel on Non-motor Symptoms in Patients with Advanced Parkinson's Disease. Mov Disord Clin Pract. 2017 Nov-Dec;4(6):829-837. doi: 10.1002/mdc3.12526. Epub 2017 Sep 20.

  PMID: 29242809 BACKGROUND

MeSH Terms

Interventions

carbidopa, levodopa drug combination; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Janet Benesh, BS

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 16, 2021
• Results First Posted: February 8, 2017

Record last verified: 2021-07