Memantine in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00181298
• Date of registration: 13/09/2005
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins University
• Public title: Memantine in Systemic Lupus Erythematosus
• Scientific title: Memantine in Systemic Lupus Erythematosus
• Date of first enrolment: March 2006
• Target sample size: 61
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00181298
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Michelle Petri, M.D., M.P.H.
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of SLE

- Self-reported cognitive impairment

Exclusion Criteria:

- Age < 18 years.

- History of non-compliance

- Pregnancy

- Liver or renal insufficiency/failure (calculated creatinine clearance < 50 cc/min)

- Severe SLE flare in the last 6 weeks (defined as SLEDAI > 12 points)

- Recent (within 4 weeks) change in any medication relevant to cognitive function,
including prednisone, anti-depressants, medications for insomnia, narcotic
medications, attention deficit disorder medications

- Current alcohol or illicit drug abuse

- Current use of Namenda, Aricept, Provigil



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Memantine

Drug: Placebo

Primary Outcome(s)

Change in ANAM, Version 3.11 [Time Frame: 12 Weeks]

Secondary ID(s)

NAM-MD-20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories