A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis

NCT00529581 | Completed Phase 2

• 1 other identifier: 22029
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 30

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.

Conditions

Cognition Disorders; Multiple Sclerosis

Keywords

multiple sclerosis; cognitive impairment; cognitive dysfunction; Cognitive Dysfunction associated with Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Symbol Digit Modalities Test, Oral Version (SDMT) - Total # Correct

  Change from baseline

• Subject's Global Assessment of Cognitive Change

  Change from baseline

Interventions

C105 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cognition Pharmaceuticals, LLC: lead

Study Sites (30)

Saint Joseph's Hospital, Barrow Neurology Clinics

Phoenix, Arizona, 85013, United States

Location

Northwest Neuro Specialists, PLLC

Tuscon, Arizona, 85741, United States

Location

Research Center for Clinical Studies West

Lancaster, California, 93534, United States

Location

Loma Linda University, Department of Neurology

Loma Linda, California, 92354, United States

Location

Associated Neurologists, P.C.

Danbury, Connecticut, 06810, United States

Location

Associated Neurologist of Southern Connecticut, PC

Fairfield, Connecticut, 06824, United States

Location

Yale University MS Center

New Haven, Connecticut, 06510, United States

Location

Neurology Associates, PA

Maitland, Florida, 32751, United States

Location

Lovelace Scientific Resources

Sarasota, Florida, 34233, United States

Location

Roskamp Institute

Sarasota, Florida, 34243, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33701, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

Shepard Center

Atlanta, Georgia, 30309, United States

Location

University of Kansas Medical Center, Department of Neurology

Kansas City, Kansas, 66160, United States

Location

MidAmerica Neuroscience Institute

Lenexa, Kansas, 66214, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Henry Ford Health System, Department of Neurology

Detroit, Michigan, 48202, United States

Location

Northern Michigan Neurology

Traverse City, Michigan, 49684, United States

Location

The Jacobs Neurological Institute

Buffalo, New York, 14203, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 17607, United States

Location

MeritCare Neuroscience Clinic

Fargo, North Dakota, 58103, United States

Location

Neurology & Neuroscience Associates, Inc.

Akron, Ohio, 44302, United States

Location

Riverhills Healthcare, Inc

Cincinnati, Ohio, 45242, United States

Location

The Neurology Foundation, Inc.

Providence, Rhode Island, 02905, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Central Texas Neurology

Round Rock, Texas, 78681, United States

Location

Integra Clinical Research

San Antonio, Texas, 78229, United States

Location

University of Virginia, Department of Neurology

Charlottesville, Virginia, 22908, United States

Location

Neurological Associates, Inc

Richmond, Virginia, 23230, United States

Location

Capitol Neurology

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Cognition Disorders; Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Frederick Munschauer, MD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

• Ralph Benedict, PhD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: November 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 28, 2008

Record last verified: 2008-05

Locations

US (30)