NCT00357994

Brief Summary

The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2009

Typical duration for phase_3

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2006

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 16, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

2.7 years

First QC Date

July 27, 2006

Results QC Date

January 12, 2015

Last Update Submit

January 12, 2015

Conditions

Advanced Parkinson's Disease

Keywords

carbidopalevodopa-carbidopalevodopalevodopa/carbidopa suspensiondyskinesiaDuodopalevodopa-carbidopa intestinal gelSevere Motor FluctuationsDUOPA

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Week 12 in Average Daily Normalized "Off" Time

    Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.

    Baseline, Week 12

Secondary Outcomes (23)

  • Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12

    Baseline, Week 12

  • Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12

    Baseline, Week 12

  • Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12

    Baseline, Week 12

  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12

    Baseline, Week 12

  • Change From Baseline in UPDRS Part III Score at Week 12

    Baseline, Week 12

  • +18 more secondary outcomes

Study Arms (2)

Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo Capsules

EXPERIMENTAL

Participants were randomized to LCIG (levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.

Drug: Levodopa carbidopa intestinal gel (LCIG)Drug: Placebo (PBO) oral capsulesDevice: CADD-Legacy® 1400 ambulatory infusion pumpDevice: PEG tubeDevice: J-tube

Placebo Gel + Levodopa-Carbidopa Capsules

ACTIVE COMPARATOR

Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.

Drug: Placebo gelDrug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tabletsDevice: CADD-Legacy® 1400 ambulatory infusion pumpDevice: PEG tubeDevice: J-tube

Interventions

Levodopa carbidopa intestinal gel (LCIG)DRUG

infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa per/hour)

Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo Capsules
Placebo gelDRUG
Placebo Gel + Levodopa-Carbidopa Capsules
Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tabletsDRUG
Placebo Gel + Levodopa-Carbidopa Capsules
Placebo (PBO) oral capsulesDRUG
Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo Capsules
CADD-Legacy® 1400 ambulatory infusion pumpDEVICE
Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo CapsulesPlacebo Gel + Levodopa-Carbidopa Capsules
PEG tubeDEVICE

percutaneous endoscopic gastrostomy tube

Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo CapsulesPlacebo Gel + Levodopa-Carbidopa Capsules
J-tubeDEVICE

jejunal tube

Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo CapsulesPlacebo Gel + Levodopa-Carbidopa Capsules

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
  • Levodopa-responsive participants who demonstrate some identifiable 'on response,' established by Investigator observation
  • Demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

You may not qualify if:

  • Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
  • Undergone surgery for the treatment of PD
  • Contraindications to levodopa
  • Subjects with any neurological deficit that may interfere with the study assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Site Reference ID/Investigator# 45719

Los Angeles, California, 90033, United States

Location

Site Reference ID/Investigator# 45718

Englewood, Colorado, 80113, United States

Location

Site Reference ID/Investigator# 45722

Washington D.C., District of Columbia, 20007, United States

Location

Site Reference ID/Investigator# 45721

Bradenton, Florida, 34205, United States

Location

Site Reference ID/Investigator# 45705

Gainesville, Florida, 32610, United States

Location

Site Reference ID/Investigator# 45740

Baltimore, Maryland, 21201, United States

Location

Site Reference ID/Investigator# 45739

St Louis, Missouri, 63110, United States

Location

Site Reference ID/Investigator# 45703

Burlington, Vermont, 05401, United States

Location

Site Reference ID/Investigator# 44970

Bochum, 44791, Germany

Location

Site Reference ID/Investigator# 44971

Bremerhaven, 27574, Germany

Location

Site Reference ID/Investigator# 44973

Dresden, 01307, Germany

Location

Site Reference ID/Investigator# 44965

Hanover, 30625, Germany

Location

Site Reference ID/Investigator# 44964

Kiel, 24105, Germany

Location

Site Reference ID/Investigator# 44966

Marburg, 35033, Germany

Location

Site Reference ID/Investigator# 44968

Tübingen, 72076, Germany

Location

Related Publications (3)

  • Shih TM, Sail KR, Jalundhwala YJ, Sullivan J, van Eijndhoven E, Zadikoff C, Marshall TS, Lakdawalla DN. The effect of functional status impairment on nursing home admission risk among patients with advanced Parkinson's disease. J Med Econ. 2020 Mar;23(3):297-307. doi: 10.1080/13696998.2019.1693383. Epub 2019 Nov 28.

    PMID: 31779508DERIVED

  • Lew MF, Slevin JT, Kruger R, Martinez Castrillo JC, Chatamra K, Dubow JS, Robieson WZ, Benesh JA, Fung VS. Initiation and dose optimization for levodopa-carbidopa intestinal gel: Insights from phase 3 clinical trials. Parkinsonism Relat Disord. 2015 Jul;21(7):742-8. doi: 10.1016/j.parkreldis.2015.04.022. Epub 2015 Apr 28.

    PMID: 25962554DERIVED

  • Olanow CW, Kieburtz K, Odin P, Espay AJ, Standaert DG, Fernandez HH, Vanagunas A, Othman AA, Widnell KL, Robieson WZ, Pritchett Y, Chatamra K, Benesh J, Lenz RA, Antonini A; LCIG Horizon Study Group. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol. 2014 Feb;13(2):141-9. doi: 10.1016/S1474-4422(13)70293-X. Epub 2013 Dec 20.

    PMID: 24361112DERIVED

Related Links

MeSH Terms

Conditions

Dyskinesias

Interventions

carbidopa, levodopa drug combinationTabletsJejunostomy

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsEnterostomyDigestive System Surgical ProceduresSurgical Procedures, OperativeOstomy

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie (prior sponsor, Abbott)
800-633-9110

Study Officials

  • Janet Benesh

    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
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 28, 2006

Study Start

January 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 16, 2015

Results First Posted

January 16, 2015

Record last verified: 2015-01

Locations

US(8)DE(7)