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

Cognition Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Cognition Disorders

Multiple Sclerosis

Treatments

Drug: C105

Study type

Interventional

Funder types

Industry

Identifiers

NCT00529581

22029

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care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