Systemic Lupus ErythematosusNCT00297284
Memory and Attention Problems in Lupus: New Treatment Trial With Modafinil
A study testing Modafinil in people with Systemic Lupus Erythematosus, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Modafinil
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Pilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE Patients
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.
Read the 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 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Modafinil
- Keywords
- systemic lupus erythematosus, cognitive efficiency, cognitive dysfunction, cognition, memory, attention, modafinil, provigil
- Medical subject headings
- Lupus Erythematosus, Systemic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Investigators
- Melanie J. Harrison, MD, MS, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297284
- Sponsor's protocol ID
- 25085
- Status last verified
- Sep 2006
- First submitted
- 24 Feb 2006
- Last updated
- 28 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE Patients
- ClinicalTrials.gov ID
- NCT00297284
- Acronym / sponsor ID
- 25085
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- systemic lupus erythematosus, cognitive efficiency, cognitive dysfunction, cognition, memory, attention, modafinil, provigil
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Feb 2007
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modafinil | Drug | – |
Primary outcome
Improvement in cognitive efficiency at 6 weeks
4 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie J. Harrison, MD, MS principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modafinil in people with Systemic Lupus Erythematosus, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in cognitive efficiency at 6 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009.