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Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-Motor Symptoms in Patients With Idiopathic Parkinson's Disease
This study has been terminated.
( slow enrollment )
First Received: March 19, 2008   Last Updated: April 22, 2009   History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00642356
  Purpose

The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on end-of-dose wearing off in persons who have Parkinson's disease.


Condition Intervention Phase
Parkinson's Disease
Drug: Carbidopa/levodopa/entacapone, IR carbidopa/levodopa
Phase IV

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Levodopa Carbidopa Sinemet OR 611 Entacapone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An 8-Week, Prospective, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Multi-Center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-Motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-Motor Symptoms of Wearing

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Compare effects of carbidopa/levodopa/entacapone versus IR carbidopa/levodopa on the non-motor symptoms in patients with idiopathic PD and non-motor symptoms of wearing off using the non-motor subscale of the QWOQ-9 item from baseline to end of study [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare effects of carbidopa/levodopa/entacapone versus IR carbidopa/levodopa on the motor symptoms in patients with idiopathic PD and non motor symptoms of wearing off using the motor subscale of the QWOQ-9 (mQWOQ-9) from baseline to end of study. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Compare effects of carbidopa/levodopa/entacapone versus IR carbidopa/levodopa on the non-motor symptoms in patients with idiopathic PD and non-motor symptoms of wearing off using the Hamilton Anxiety Scale (HAM-A) from baseline to end of study. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Compare effects of carbidopa/levodopa/entacapone versus IR carbidopa/levodopa on apathy and depression using the Apathy Scale and Quick Inventory of Depressive Symptomatology-Self Reporting 16-item (QIDS-SR16) respectively, from baseline to end of study. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Assess occurrence and severity of symptoms of impulse control, as measured with the Modified Minnesota Impulsive Disorder Interview assessment (Modified MIDI), of carbidopa/levodopa/entacapone versus IR carbidopa/levodopa from baseline to end of study. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: February 2008
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Carbidopa/levodopa/entacapone plus immediate release carbidopa/levodopa placebo
Drug: Carbidopa/levodopa/entacapone, IR carbidopa/levodopa
2: Placebo Comparator
Immediate release carbidopa/levodopa plus Carbidopa/levodopa/entacapone placebo
Drug: Carbidopa/levodopa/entacapone, IR carbidopa/levodopa

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be aged 30 to 85 years.
  • Be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.
  • Have a clinical diagnosis of idiopathic Parkinson's Disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)
  • Have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of Parkinson's Disease which improves with the next immediate release (IR) carbidopa/levodopa dose as determined by the Quantitative Wearing-Off Questionnaire 9 and investigator's assessment. At least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (IR) carbidopa/levodopa administration. (all criteria must be fulfilled)
  • Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 28 days prior to randomization at an equivalent total daily dose of immediate release (IR) carbidopa/levodopa between 300 to 600 mg. Dosing should be either 3 or 4 times per day.
  • Be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.

Exclusion Criteria:

  • Have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;
  • Have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;
  • Have unstable Parkinson's Disease requiring frequent booster doses;
  • Disabling dyskinesias, indicated by a score of greater than 1 on Unified Parkinson Disease Rating Scale question #32, or a score of greater than 1 on Unified Parkinson Disease Rating Scale question #33;
  • Have a history or current diagnosis of psychotic features according to the investigator;
  • Have a history or current diagnosis of symptoms of an impulse control disorder according to a screening assessment with the modified Minnesota Impulsive Disorders Interview and the investigator's judgment;
  • Have a diagnosis of Bipolar Disorder I or II according to the Diagnostic Statistical Manual, Fourth Edition;
  • Demonstrate indications of marked suicidal tendencies as assessed by the investigator;
  • Have undergone psychotherapy or psychiatric pharmacotherapy, currently or within 28 days prior to randomization;
  • If female, be pregnant, trying to become pregnant or nursing an infant;
  • Diagnostic and Statistical Manual, Fourth Edition, Text Revision; [American Psychiatric Association, 2000] diagnosis of 1. dementia (of any cause); 2.

moderate or severe major depression, present independent from the time of first diagnosis of Parkinson's Disease, as defined by a Quick Inventory of Depressive Symptomatology -Self Rating 16 score of > 15; or 3. generalized anxiety disorder or panic disorder if made prior to the diagnosis of Parkinson's Disease;

  • Have received treatment with MAO-inhibitors;
  • Diagnostic and Statistical Manual, Fourth Edition, Text Revision diagnosis of alcohol or substance abuse (excluding nicotine or caffeine) during the 3 months prior to randomization) or alcohol or substance dependence (excluding nicotine or caffeine) during the 6 months prior to randomization. Alcohol should be avoided within the 12 hours preceding the Screening, Baseline, Week 2 and Week 8 visits;
  • Diagnostic and Statistical Manual, Fourth Edition, Text Revision diagnosis of dysthymia within the last 12 months;
  • Have a history or current diagnosis of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642356

Locations
United States, Arizona
Xenoscience, Inc
Phoenix, Arizona, United States, 85004
United States, California
University of California
Irvine, California, United States, 92697
Coastal Neurological Medical Group, Inc
La Jolla, California, United States, 92037
South Coast Health Center
Aliso Viejo, California, United States, 92656
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Sunrise Clinical Research, Inc
Hollywood, Florida, United States, 33021
Charlotte Neurological Services
Port Charlotte, Florida, United States, 33952
United States, Kansas
Cotton O'Neil Clinic
Topeka, Kansas, United States, 66606
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Missouri
Dr. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
Neurology, Inc
Columbia, Missouri, United States, 65201
United States, Nebraska
Creighton U Medical Center, Dept of Neurology
Omaha, Nebraska, United States, 68131
United States, New York
Parkinson's Disease & Movement Disorders
Commack, New York, United States, 11725
Neurological Care of Central NY
Syracuse, New York, United States, 13210
Central New York Research Corporation
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Pennsylvania
University of Pittsburg
Pittsburg, Pennsylvania, United States, 15213
Neurology Associates
Monroeville, Pennsylvania, United States, 15146
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Scott & White Hospital
Temple, Texas, United States, 76508
University of Texas Medical School
Houston, Texas, United States, 77030
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CELC200AUS14
Study First Received: March 19, 2008
Last Updated: April 22, 2009
ClinicalTrials.gov Identifier: NCT00642356     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Idiopathic Parkinson's disease
carbidopa/levodopa/entacapone
non-motor symptoms
motor-symptoms

Study placed in the following topic categories:
Neurotransmitter Agents
Levodopa
Ganglion Cysts
Immunologic Factors
Basal Ganglia Diseases
Carbidopa
Adjuvants, Immunologic
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Entacapone
Dopamine
Parkinson Disease
Movement Disorders
Sinemet
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Anti-Dyskinesia Agents
Basal Ganglia Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Neurodegenerative Diseases
Brain Diseases
Dopamine Agonists
Movement Disorders
Therapeutic Uses
Levodopa
Carbidopa
Nervous System Diseases
Adjuvants, Immunologic
Central Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Entacapone
Parkinson Disease
Sinemet
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009