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

NCT00297284 | Terminated

• 1 other identifier: 25085
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; cognitive efficiency; cognitive dysfunction; cognition; memory; attention; modafinil; provigil

Outcome Measures

Primary Outcomes (1)

• Improvement in cognitive efficiency at 6 weeks

Secondary Outcomes (4)

• Change in performance of cognitive activities at six weeks

• Change in fatigue at six weeks

• Change in sleep at six weeks

• Adverse events, including an increase in SLE activity, at six weeks

Interventions

Modafinil DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Cognitive Dysfunction

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Melanie J. Harrison, MD, MS

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: February 1, 2006
• Study Completion: February 1, 2007
• Last Updated: January 28, 2009

Record last verified: 2006-09

Locations

US (1)