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

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00357994

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 with placebo capsules Drug: levodopa-carbidopa intestinal placebo gel with active oral medication (capsules containing levodopa-carbidopa tablets) Device: CADD-Legacy® 1400 ambulatory infusion pump	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa/Carbidopa Suspension for Upper-Intestinal Infusion 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

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

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 ]

Estimated Enrollment:	54
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: levodopa-carbidopa intestinal gel with 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
2: Placebo Comparator	Drug: levodopa-carbidopa intestinal placebo gel with active oral medication (capsules containing levodopa-carbidopa tablets) 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

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: NCT00357994

Contacts

Contact: Staci Rokette

staci.rokette@solvay.com

Locations

United States, Florida
Site 107	Recruiting
Gainesville, Florida, United States
Site 106	Not yet recruiting
Tampa, Florida, United States
United States, Pennsylvania
Site 124	Not yet recruiting
Philadelphia, Pennsylvania, United States
Germany
Site 435	Recruiting
Marburg, Germany
Site 434	Not yet recruiting
Leipzig, Germany
Site 437	Recruiting
Kiel, Germany
Site 438	Recruiting
Hannover, Germany
Site 436	Recruiting
Bremerhaven, Germany
Site 433	Recruiting
Dresden, Germany
Site 439	Recruiting
Bochum, Germany

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Staci Rokette )
Study ID Numbers:	S187.3.001, 2006-000577-29
Study First Received:	July 27, 2006
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00357994 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Solvay Pharmaceuticals:

efficacy
Parkinson's Disease
Severe Motor Fluctuations
dyskinesia

levodopa
carbidopa
levodopa/carbidopa suspension

Study placed in the following topic categories:

Neurotransmitter Agents
Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Carbidopa
Central Nervous System Diseases
Brain Diseases

Neurodegenerative Diseases
Dyskinesias
Dopamine
Parkinson Disease
Movement Disorders
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Levodopa
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Carbidopa
Central Nervous System Diseases
Antiparkinson Agents

Enzyme Inhibitors
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009