Clinical trial NCT00529581: A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of C105 in Persons With Multiple Sclerosis With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cognition Disorders
Multiple Sclerosis
Keywords: multiple sclerosis
cognitive impairment
cognitive dysfunction
Cognitive Dysfunction associated with Multiple Sclerosis
Lead sponsor: Cognition Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of C105 in treating the cognitive deficits that can occur due to multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

* Males/females at least 18 years old and \< 65 years old, capable of understanding and complying with the protocol, including speaking and writing fluent English and having at least a 9th grade education
* 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care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:

* Subjects with memory deficits caused by concomitant medication usage or other significant neurological/psychological disease, e.g., Alzheimer's disease, Parkinson's disease, stroke, TIA, Multi-infarct dementia, Huntington's disease, head trauma, or chronic CNS infection
* 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

Primary outcomes:
measure: Symbol Digit Modalities Test, Oral Version (SDMT) - Total # Correct
timeFrame: Change from baseline
measure: Subject's Global Assessment of Cognitive Change
timeFrame: Change from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Saint Joseph's Hospital, Barrow Neurology Clinics
state: Arizona
city: Tuscon
country: United States
facility: Northwest Neuro Specialists, PLLC
state: Arizona
city: Lancaster
country: United States
facility: Research Center for Clinical Studies West
state: California
city: Loma Linda
country: United States
facility: Loma Linda University, Department of Neurology
state: California
city: Danbury
country: United States
facility: Associated Neurologists, P.C.
state: Connecticut
city: Fairfield
country: United States
facility: Associated Neurologist of Southern Connecticut, PC
state: Connecticut
city: New Haven
country: United States
facility: Yale University MS Center
state: Connecticut
city: Maitland
country: United States
facility: Neurology Associates, PA
state: Florida
city: Sarasota
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute
state: Florida
city: St. Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Atlanta
country: United States
facility: Shepard Center
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center, Department of Neurology
state: Kansas
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Health System, Department of Neurology
state: Michigan
city: Traverse City
country: United States
facility: Northern Michigan Neurology
state: Michigan
city: Buffalo
country: United States
facility: The Jacobs Neurological Institute
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Fargo
country: United States
facility: MeritCare Neuroscience Clinic
state: North Dakota
city: Akron
country: United States
facility: Neurology & Neuroscience Associates, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Riverhills Healthcare, Inc
state: Ohio
city: Providence
country: United States
facility: The Neurology Foundation, Inc.
state: Rhode Island
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia, Department of Neurology
state: Virginia
city: Richmond
country: United States
facility: Neurological Associates, Inc
state: Virginia
city: Charleston
country: United States
facility: Capitol Neurology
state: West Virginia
Study officials:
affiliation: SUNY Buffalo
name: Frederick Munschauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY Buffalo
name: Ralph Benedict, PhD
role: PRINCIPAL_INVESTIGATOR
References: