Memory and Attention Problems in Lupus: New Treatment Trial With Modafinil

• Status: Terminated
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted in order to determine if the FDA-approved drug Modafinil can improve cognitive function in patients with lupus. Modafinil is currently being used to treat excessive sleepiness caused by certain sleep disorders. It has also been shown to improve attention and concentration in some people who don't have lupus or sleep disorders. This study hopes to determine if Modafinil can be used safely and effectively in lupus patients, and improve their quality of life. No medications currently exist for the treatment of lupus-associated cognitive dysfunction.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• Fulfill ACR Classification Criteria for SLE

• >18 and < 60 years old

• English-speaking/reading

• Has a treating rheumatologist at the Hospital for Special Surgery

• Estimated premorbid verbal I.Q. >80 measured by the North American Adult Reading Test

• Functional difficulties due to cognitive dysfunction defined as positive endorsement of ≥6 items on the Cognitive Symptoms Inventory (CSI). The CSI is a 21-item, self-report questionnaire designed to assess ability to perform everyday activities in patients with rheumatic disease.47

• No physical or mental disabilities that would preclude or confound the results of the neuropsychological testing, e.g., compromised use of hands, severe visual or hearing impairment

• Able to read normal newsprint and hear a normal speaking voice

• Normotensive at time of enrollment with or without medication

• No arrhythmia or left ventricular hypertrophy on ECG

• Adequate contraception (barrier method)

Exclusion Criteria:

• Global cognitive impairment as measured by a Modified Mini Mental Status<77

• History of arrhythmia; known history of left ventricular hypertrophy, mitral valve prolapse with syndrome, or other significant cardiovascular disease with a reduced ejection fraction

• Renal insufficiency (creatinine clearance < 30 ml/min) including dialysis patients

• Known liver disease (e.g., active hepatitis) or any liver function test >2x upper limit of normal (transaminases or GGTP)

• Significant and serious SLE activity defined as active central nervous system disease, active nephritis, ulcerative skin disease. Other active SLE-associated conditions involving major organ systems may be excluded at the discretion of the investigator.

• Pregnancy, nursing mother, or unwillingness to use barrier contraception

• Diagnosis of active psychosis, ADHD, ADD

• Current use of medications contraindicated with the use of modafinil-triazolam, Phenobarbital, cyclosporine A, theophylline, carbamazepine, diazepam, phenytoin, mephenytoin, rifampin, ketoconazole, itraconazole,

• Illegal drug or alcohol abuse (defined as two affirmative responses to the CAGE questionnaire)

• Prior use of modafinil