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

NCT ID: NCT00335153

Last Updated: 2015-01-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-06-30

Brief Summary

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The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

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Detailed Description

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The study was composed of a screening period followed by 3 sequential on-treatment periods, as follows:

* Screening Period (up to 28 days): determination of eligibility and discontinuation of antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (NJ) tube placement.
* NJ Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of NJ tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via NJ tube and infusion pump (participant was hospitalized for NJ tube placement but hospitalization was not required for entire duration of LCIG treatment optimization).
* PEG-J Period (2 to 14 days): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment.
* Post PEG-J Long-Term Treatment Period (Day 28 to Day 378): LCIG administration via a permanent PEG-J tube and infusion pump, with dosage adjusted according to clinical condition.

Conditions

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Advanced Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levodopa-Carbidopa Intestinal Gel (LCIG)

All participants were to receive LCIG, via the NJ tube during the nasojejunal (NJ) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances.

Group Type EXPERIMENTAL

Levodopa-carbidopa intestinal gel

Intervention Type 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/hour).

CADD-Legacy® 1400 ambulatory infusion pump

Intervention Type DEVICE

PEG tube

Intervention Type DEVICE

percutaneous endoscopic gastrostomy tube

J-tube

Intervention Type DEVICE

jejunal tube

Interventions

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Levodopa-carbidopa intestinal gel

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/hour).

Intervention Type DRUG

CADD-Legacy® 1400 ambulatory infusion pump

Intervention Type DEVICE

PEG tube

percutaneous endoscopic gastrostomy tube

Intervention Type DEVICE

J-tube

jejunal tube

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
* Levodopa-responsive with severe motor fluctuations
* Recognizable off and on state (motor fluctuations) confirmed by diary

Exclusion Criteria

* 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 (such as narrow angle glaucoma)
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet Benesh

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 50065

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 50059

Fountain Valley, California, United States

Site Status

Site Reference ID/Investigator# 50048

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 50076

Oceanside, California, United States

Site Status

Site Reference ID/Investigator# 50061

Englewood, Colorado, United States

Site Status

Site Reference ID/Investigator# 50079

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

Site Status

Site Reference ID/Investigator# 50077

Bradenton, Florida, United States

Site Status

Site Reference ID/Investigator# 50060

Fort Lauderdale, Florida, United States

Site Status

Site Reference ID/Investigator# 50049

Gainesville, Florida, United States

Site Status

Site Reference ID/Investigator# 50047

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 50068

Port Charlotte, Florida, United States

Site Status

Site Reference ID/Investigator# 50046

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 50062

Augusta, Georgia, United States

Site Status

Site Reference ID/Investigator# 50050

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 50078

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 50064

Lexington, Kentucky, United States

Site Status

Site Reference ID/Investigator# 50075

Shreveport, Louisiana, United States

Site Status

Site Reference ID/Investigator# 50080

Baltimore, Maryland, United States

Site Status

Site Reference ID/Investigator# 50074

Baltimore, Maryland, United States

Site Status

Site Reference ID/Investigator# 50073

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 50042

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 50072

Manhasset, New York, United States

Site Status

Site Reference ID/Investigator# 50067

New York, New York, United States

Site Status

Site Reference ID/Investigator# 50066

New York, New York, United States

Site Status

Site Reference ID/Investigator# 50069

Raleigh, North Carolina, United States

Site Status

Site Reference ID/Investigator# 50063

Winston-Salem, North Carolina, United States

Site Status

Site Reference ID/Investigator# 50043

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 50044

Cleveland, Ohio, United States

Site Status

Site Reference ID/Investigator# 50058

Burlington, Vermont, United States

Site Status

Site Reference ID/Investigator# 50045

Kirkland, Washington, United States

Site Status

Site Reference ID/Investigator# 50070

Milwaukee, Wisconsin, United States

Site Status

Site Reference ID/Investigator# 46429

Adelaide, , Australia

Site Status

Site Reference ID/Investigator# 46427

Heidelberg, , Australia

Site Status

Site Reference ID/Investigator# 46425

Westmead, , Australia

Site Status

Site Reference ID/Investigator# 54545

Edmonton, , Canada

Site Status

Site Reference ID/Investigator# 46433

Montreal, , Canada

Site Status

Site Reference ID/Investigator# 46434

Toronto, , Canada

Site Status

Site Reference ID/Investigator# 46436

Brno, , Czechia

Site Status

Site Reference ID/Investigator# 46438

Hradec Králové, , Czechia

Site Status

Site Reference ID/Investigator# 46435

Pardubice, , Czechia

Site Status

Site Reference ID/Investigator# 46437

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 46439

Prague, , Czechia

Site Status

Site Reference ID/Investigator# 48003

Lahti, , Finland

Site Status

Site Reference ID/Investigator# 48028

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 48029

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 48036

Freiburg im Breisgau, , Germany

Site Status

Site Reference ID/Investigator# 48034

Göttingen, , Germany

Site Status

Site Reference ID/Investigator# 48022

Hanau, , Germany

Site Status

Site Reference ID/Investigator# 48024

Hanover, , Germany

Site Status

Site Reference ID/Investigator# 48035

Mainz, , Germany

Site Status

Site Reference ID/Investigator# 49882

Tel Aviv, , Israel

Site Status

Site Reference ID/Investigator# 50131

Arcugnano, , Italy

Site Status

Site Reference ID/Investigator# 50132

Catania, , Italy

Site Status

Site Reference ID/Investigator# 50128

Genoa, , Italy

Site Status

Site Reference ID/Investigator# 50129

Lido di Camaiore, , Italy

Site Status

Site Reference ID/Investigator# 50130

Naples, , Italy

Site Status

Site Reference ID/Investigator# 50127

Rome, , Italy

Site Status

Site Reference ID/Investigator# 50138

Nijmegen, , Netherlands

Site Status

Site Reference ID/Investigator# 50126

Auckland, , New Zealand

Site Status

Site Reference ID/Investigator# 50123

Christchurch, , New Zealand

Site Status

Site Reference ID/Investigator# 50124

Hamilton, , New Zealand

Site Status

Site Reference ID/Investigator# 50125

Wellington, , New Zealand

Site Status

Site Reference ID/Investigator# 50140

Lodz, , Poland

Site Status

Site Reference ID/Investigator# 50139

Poznan, , Poland

Site Status

Site Reference ID/Investigator# 50136

Almada, , Portugal

Site Status

Site Reference ID/Investigator# 50134

Coimbra, , Portugal

Site Status

Site Reference ID/Investigator# 50135

Lisbon, , Portugal

Site Status

Site Reference ID/Investigator# 50137

Porto, , Portugal

Site Status

Site Reference ID/Investigator# 50143

Kazan', , Russia

Site Status

Site Reference ID/Investigator# 50141

Moscow, , Russia

Site Status

Site Reference ID/Investigator# 50145

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 50142

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 50147

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 50146

Saint Petersburg, , Russia

Site Status

Site Reference ID/Investigator# 50154

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 50152

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 50202

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 50155

Barcelona, , Spain

Site Status

Site Reference ID/Investigator# 50153

Madrid, , Spain

Site Status

Site Reference ID/Investigator# 50150

Bangkok, , Thailand

Site Status

Site Reference ID/Investigator# 50151

Bangkok, , Thailand

Site Status

Site Reference ID/Investigator# 50149

Liverpool, , United Kingdom

Site Status

Site Reference ID/Investigator# 50148

London, , United Kingdom

Site Status

Countries

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United States Australia Canada Czechia Finland Germany Israel Italy Netherlands New Zealand Poland Portugal Russia Spain Thailand United Kingdom

References

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Chang FC, Kwan V, van der Poorten D, Mahant N, Wolfe N, Ha AD, Griffith JM, Tsui D, Kim SD, Fung VS. Intraduodenal levodopa-carbidopa intestinal gel infusion improves both motor performance and quality of life in advanced Parkinson's disease. J Clin Neurosci. 2016 Mar;25:41-5. doi: 10.1016/j.jocn.2015.05.059. Epub 2016 Jan 14.

Reference Type DERIVED
PMID: 26777085 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25962554 (View on PubMed)

Fernandez HH, Standaert DG, Hauser RA, Lang AE, Fung VS, Klostermann F, Lew MF, Odin P, Steiger M, Yakupov EZ, Chouinard S, Suchowersky O, Dubow J, Hall CM, Chatamra K, Robieson WZ, Benesh JA, Espay AJ. Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: final 12-month, open-label results. Mov Disord. 2015 Apr;30(4):500-9. doi: 10.1002/mds.26123. Epub 2014 Dec 24.

Reference Type DERIVED
PMID: 25545465 (View on PubMed)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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2006-005186-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S187.3.004

Identifier Type: -

Identifier Source: org_study_id

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