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

Phase

N/A

Condition

Lupus

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Treatment

N/A

Clinical Study ID

NCT00297284

25085

Ages 18-60
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 endorsementof ≥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 inpatients with rheumatic disease.47
No physical or mental disabilities that would preclude or confound the results of theneuropsychological testing, e.g., compromised use of hands, severe visual or hearingimpairment
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

Exclusion Criteria:

Global cognitive impairment as measured by a Modified Mini Mental Status<77
History of arrhythmia; known history of left ventricular hypertrophy, mitral valveprolapse with syndrome, or other significant cardiovascular disease with a reducedejection fraction
Renal insufficiency (creatinine clearance < 30 ml/min) including dialysis patients
Known liver disease (e.g., active hepatitis) or any liver function test >2x upperlimit 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 conditionsinvolving 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 CAGEquestionnaire)
Prior use of modafinil

Study Design

February 01, 2006

February 28, 2007

Study 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 daily life.

Cognitive dysfunction is a well-recognized manifestation of systemic lupus erythematosus (SLE) whose reported prevalence ranges from 12-87%. SLE-associated cognitive dysfunction often occurs in the absence of frank neuropsychiatric disease (e.g., stroke, depression, psychosis, cerebral vasculitis), medications known to have central nervous system effects, or increased disease activity or flare. Studies of SLE antibodies (most notably the antiphospholipid antibodies) have provided conflicting results with respect to their association with SLE-associated cognitive dysfunction. Thus, despite numerous investigations, the etiology of SLE-associated cognitive dysfunction remains unclear. There is no known means for preventing cognitive dysfunction in SLE. Similarly there are no established or proven treatments for cognitive dysfunction in SLE.

Regardless of its cause, course, or long-term consequences, cognitive dysfunction in SLE is a major cause of distress, compromised performance of everyday activities, and decreased quality of life. Thus, treatment of decreased cognitive performance in SLE when it occurs, no matter how mild, and regardless of its potential for permanence or progression, is of paramount importance. It is imperative to provide SLE patients with cognitive performance difficulties with the means to functionally cope with their impairments so that they can maintain, if not regain their independence.

Modafinil is a safe, orally administered wakefulness-promoting agent approved for use in adults suffering from narcolepsy, idiopathic hypersomnia, obstructive sleep apnea, and shift work sleep syndrome. Since its FDA approval, it has been used for many additional varied conditions including depression, fatigue, fibromyalgia, myotonic dystrophy, organic brain syndrome, sleep deprivation, Parkinson's, and drug-induced somnolence. It has also been used in helicopter and airplane pilots to enhance their attentiveness during long flights. Some of our SLE patients have been prescribed modafinil for narcolepsy or associated fatigue.

Modafinil has broad efficacy in health and illness. It enhances cognitive function in normal young adult males, as tested by digit span, visual pattern recognition memory, spatial planning and stop-signal reaction time. While the majority of patients prescribed modafinil received the drug for non-cognitive indications (e.g., fatigue, sleepiness), several have reported improved cognitive function, especially with respect to tasks that require attention and concentration.

We hypothesize that Modafinil, an FDA-approved, non-specific wakefulness-promoting agent with minimal side effects, is safe and effective when used to improve cognitive efficiency in SLE patients who identify cognitive dysfunction in themselves.

Connect with a study center

Hospital for Special Surgery
New York, New York 10021
United States
Site Not Available

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