Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS
Relapsing-Remitting Multiple Sclerosis
About this trial
This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring MS, cognition, attention, fatigue
Eligibility Criteria
Inclusion Criteria: Patients entering the study will: Be taking Avonex Have normal laboratory blood tests and EKG Be complaining of attention problems to treating neurologist Be English-speaking males and females between the ages of 25 and 60, inclusive [If patient is female, she must Be surgically sterile; or Be 2 years postmenopausal; or If of child-bearing potential, must be using a medically accepted method of birth control and agree to continue to use this method for the duration of the study (i.e., barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], IUD, or abstinence)] Have clinically definite RR MS with disease duration of less than 10 years Have an EDSS score between 0 and 5.5 Have corrected vision of no worse than 20/50 Have between 10 and 20 years of education Be cerebral-stimulant free for at least one week prior to Attention Screening Be able to complete self-rating scales and cognitive assessment tools Have provided written informed consent To have performed at least one standard deviation below normative expectation on at least two of four measures in the attention screening evaluation Exclusion Criteria: Patients entering the study will NOT: A history of heart disease or liver dysfunction Have abnormal EKG or laboratory blood work, Have a history of psychosis Be a significant risk of suicide Be abusing alcohol (current and within last 2 years) Be abusing controlled substances (current and within last 2 years) Have any medical ailment which can produce fatigue, such as lupus, anemia or thyroid disease Have any history of clinical deviation from normal ranges in the physical examination Have an unstable medical disorder, or medical contraindication to the use of Provigil Have any history of head injury, seizures, or neurological conditions involving the central nervous system other than RR MS Have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion, including gastrointestinal surgery Be a pregnant or lactating female (any patient becoming pregnant during the study will be discontinued) Have received any investigational product within 30 days of Cognitive Screening Have upper extremity dysfunction that prohibits them from using a computer mouse writing with a pencil Be colorblind
Sites / Locations
- Veterans Affairs Medical CenterRecruiting