Status:
TERMINATED
Memory and Attention Problems in Lupus: New Treatment Trial With Modafinil
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 sleep...
Detailed Description
This is a 6-week pilot and feasibility single-arm, open-label trial of modafinil 200mg orally every morning to improve cognitive efficiency in systemic lupus patients with cognitive difficulties in da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00297284
Start Date
February 1 2006
End Date
February 1 2007
Last Update
January 28 2009
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021