Pilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE Patients

Institutional Review Board, Hospital for Special Surgery

February 27, 2006

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Melanie J. Harrison, MD, MS

Co-Investigators

Michael Lockshin, MD
Doruk Erkan, MD

Summary

No medications currently exist for the treatment of lupus-associated cognitive dysfunction. 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.

Twenty patients will be enrolled in this study, which involves 4 visits to The Hospital for Special Surgery over approximately 6 weeks and 4 phone interviews between in-person visits. During the study you will receive 6 weeks of modafinil 200mg orally each day.

Inclusion/Exclusion Criteria

1. Women and men who have been diagnosed with lupus and have difficulty with memory, problem-solving, and concentration are invited to take part in this study. 
2. Participants should be between the ages of 18 and 60, speak English, and not be on dialysis.  The study requires participants to be able to read normal newsprint and hear without much difficulty.
3. In addition, individuals with high blood pressure, irregular heartbeats, enlarged hearts, mitral valve prolapse, serious liver or kidney problems are not eligible to participate.  If you take certain medications, you may not be eligible for this study.  The research assistant will review the specific criteria that will determine if you may participate.
4. Because modafinil can affect hormonal birth control methods (oral contraceptives), women using birth control pills, shots, some IUDs, or patches may have a higher chance of getting pregnant while taking modafinil and for one month after stopping modafinil.

Contact Information

Research Assistants
Debbie Miller
Hospital for Special Surgery
Tel: 212.606.1867
E-mail: mailto:hmillerd@hss.edu