Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects - Full Text View

Sponsor:	Abbott
Collaborator:	Quintiles
Information provided by (Responsible Party):	Abbott
ClinicalTrials.gov Identifier:	NCT00660387

Purpose

The primary objective of this study will be to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.The study duration is 4 months.

Condition	Intervention	Phase
Advanced Parkinson's Disease	Drug: levodopa-carbidopa intestinal gel active and placebo capsules Drug: levodopa-carbidopa capsules active and placebo gel Device: CADD-Legacy® 1400 ambulatory infusion pump	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa Sinemet

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

To evaluate a difference between levodopa-carbidopa intestinal gel and active control in the change from baseline and mean daily 'off' time (hours) at Week 12 (endpoint) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate on time without troublesome dyskinesia, PDQ-39, UPDRS, caregiver burden [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	December 2009
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 levodopa-carbidopa intestinal gel	Drug: levodopa-carbidopa intestinal gel active and placebo capsules 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); Device: CADD-Legacy® 1400 ambulatory infusion pump pump
Active Comparator: 2 levodopa-carbidopa capsules	Drug: levodopa-carbidopa capsules active and placebo gel 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);

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

- Idiopathic parkinson's disease(PD)according to UKPDS Brain Bank Criteria; levodopa-responsive and subjects demonstrate some identifiable 'on response' established by observation by investigator and demonstrate sever motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

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, subjects with any neurological deficit that may interfere with the study assessments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660387

Locations

United States, Alabama
Site Reference ID/Investigator# 45931
Birmingham, Alabama, United States, 35222
United States, California
Site Reference ID/Investigator# 45910
Fountain Valley, California, United States, 92708
Site Reference ID/Investigator# 45925
Oceanside, California, United States, 92056
United States, Florida
Site Reference ID/Investigator# 45912
Port Charlotte, Florida, United States, 33890
United States, Illinois
Site Reference ID/Investigator# 45935
Chicago, Illinois, United States, 60611
United States, Kentucky
Site Reference ID/Investigator# 45930
Lexington, Kentucky, United States, 40536-0284
United States, New York
Site Reference ID/Investigator# 45934
New York, New York, United States, 10032
United States, North Carolina
Site Reference ID/Investigator# 45929
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Site Reference ID/Investigator# 45908
Cincinnati, Ohio, United States, 45267
Site Reference ID/Investigator# 45922
Cleveland, Ohio, United States, 44195-0001
United States, Washington
Site Reference ID/Investigator# 45915
Kirkland, Washington, United States, 98034
New Zealand
Site Reference ID/Investigator# 45904
Auckland, New Zealand, N/A 1023
Site Reference ID/Investigator# 45902
Christchurch, New Zealand, 8011
Site Reference ID/Investigator# 45905
Hamilton, New Zealand, 3204

Sponsors and Collaborators

Abbott

Quintiles

Investigators

Study Director:

Janet Benesh

Abbott

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00660387 History of Changes
Other Study ID Numbers:	S187.3.002, 2007-003814-32
Study First Received:	April 15, 2008
Last Updated:	December 15, 2011
Health Authority:	United States: Food and Drug Administration; New Zealand: Ministry of Health

Keywords provided by Abbott:

efficacy
Parkinson's Disease
Severe Motor Fluctuations
dyskinesia
levodopa

carbidopa
levodopa/carbidopa suspension
Duodopa
levodopa-carbidopa
intestinal gel

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Antiparkinson Agents

Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012