A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis
NCT ID: NCT00529581
Last Updated: 2008-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2006-11-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Interventions
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C105
Eligibility Criteria
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Inclusion Criteria
* Clinically definite diagnosis per McDonald criteria of Multiple Sclerosis as confirmed by the Investigator (Relapsing-Remitting or Secondary Progressive)
* Stable disease and relapse-free for \> 90 days as verified by Investigator
* Presence of cognitive deficit as measured score of -1.5 SD on the SDMT (oral version) or a score of -1.0 SD on the SDMT and -1.0 SD on either CVLT-II (total learning or delayed recall) or PASAT
* EDSS \<= 6.5
* Standard score of \>79 on the WRAT-4 Reading test
* Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care
* Capable of performing the requirements of a neuropsychological test battery including having at least 20/70 near visual acuity by near vision chart, with correction (i.e., eyeglasses) allowed
* If female, must neither be pregnant nor breast-feeding and she must either (a) be \> 12 months post-menopausal or surgically sterilized or (b) must agree to use an acceptable method of birth control (including hormonal contraceptives, intra-uterine device, or barrier methods such as condoms, diaphragm, etc. with spermicide) for the duration of the study. Abstinence will not be considered an acceptable method of birth control.
Exclusion Criteria
* Evidence of other medical cause of dementia
* Evidence of Major Depressive Disorder as determined by a Beck Fast Screen core of \>3 and clinician interview
* Use of the following medications: Antipsychotic agents, Centrally acting appetite suppression drugs (e.g., sibutramine), CNS stimulants or drugs that metabolize to them (e.g., amantadine, Concerta, methylphenidate, Adderall, ephedrine, selegiline), Strattera (atomoxetine), Tricyclic antidepressants (e.g., amitriptyline), Herbal preparations including Ginkgo Biloba or containing Ephedra or other stimulants, MAO inhibitors. Note: other medications may be excluded or permitted, depending on length of treatment and stability of dose
* Uncontrolled or labile hypertension, or any clinically significant, unstable, or major concomitant disorder as determined by the Principal Investigator
* Active malignancy within one year of study participation
* Known human immunodeficiency virus (HIV)
* Current diagnosis of unstable glaucoma
* History of myocardial infarction of symptomatic Coronary Artery Disease
* Evidence of ongoing ischemia or uncontrolled atrial or ventricular arrhythmias as shown by ECG
* History of epilepsy or other seizure disorders
* Clinically significant motor or speech residual neurological deficits (e.g., hemiparesis, aphasia) that interfere with completion of study procedures
* Baseline clinical laboratory values indicative of a clinically significant co-morbidity
* Significant recent history of (within past 12 months) or current drug or alcohol abuse (as defined by DSM-IV)
* Known allergy or hypersensitivity to amphetamines or other sympathomimetic amines
* Participation in any clinical trial with an investigational drug within 30 days prior to randomization
* In the opinion of the Principal Investigator should not participate in the study
18 Years
65 Years
ALL
No
Sponsors
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Cognition Pharmaceuticals, LLC
INDUSTRY
Principal Investigators
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Frederick Munschauer, MD
Role: PRINCIPAL_INVESTIGATOR
SUNY Buffalo
Ralph Benedict, PhD
Role: PRINCIPAL_INVESTIGATOR
SUNY Buffalo
Locations
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Saint Joseph's Hospital, Barrow Neurology Clinics
Phoenix, Arizona, United States
Northwest Neuro Specialists, PLLC
Tuscon, Arizona, United States
Research Center for Clinical Studies West
Lancaster, California, United States
Loma Linda University, Department of Neurology
Loma Linda, California, United States
Associated Neurologists, P.C.
Danbury, Connecticut, United States
Associated Neurologist of Southern Connecticut, PC
Fairfield, Connecticut, United States
Yale University MS Center
New Haven, Connecticut, United States
Neurology Associates, PA
Maitland, Florida, United States
Lovelace Scientific Resources
Sarasota, Florida, United States
Roskamp Institute
Sarasota, Florida, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Shepard Center
Atlanta, Georgia, United States
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, United States
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Henry Ford Health System, Department of Neurology
Detroit, Michigan, United States
Northern Michigan Neurology
Traverse City, Michigan, United States
The Jacobs Neurological Institute
Buffalo, New York, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
MeritCare Neuroscience Clinic
Fargo, North Dakota, United States
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, United States
Riverhills Healthcare, Inc
Cincinnati, Ohio, United States
The Neurology Foundation, Inc.
Providence, Rhode Island, United States
Baylor College of Medicine
Houston, Texas, United States
Central Texas Neurology
Round Rock, Texas, United States
Integra Clinical Research
San Antonio, Texas, United States
University of Virginia, Department of Neurology
Charlottesville, Virginia, United States
Neurological Associates, Inc
Richmond, Virginia, United States
Capitol Neurology
Charleston, West Virginia, United States
Countries
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Other Identifiers
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22029
Identifier Type: -
Identifier Source: org_study_id