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EG-501 for Cognitive Impairment in Neuropsychiatric SLE (NPSLE): Efficacy and Safety Study

NCT07281105 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2025-12-15

No results posted yet for this study

Summary

Neuropsychiatric systemic lupus erythematosus with cognitive impairment (NPSLE-CI) is a serious, disabling, and potentially life-threatening manifestation of SLE, affecting up to 80% of patients with cognitive impairments ("brain fog"), leading to substantial disability, approximately 2 times higher unemployment risk, reduced health-related quality of life (HRQoL), and mortality 2-14 times higher than the general population (standardized mortality ratio, SMR). No approved therapies exist for NPSLE cognitive dysfunction, representing a high-priority unmet need for this FDA-recognized serious condition with major functional and psychosocial burden. The objective of this study is to evaluate the safety, tolerability and efficacy of EG-501 in a precise patient subset with NPSLE. Participants will complete a full 14-week clinical trial, receiving either EG-501 or a placebo.

Conditions

  • Neuropsychiatric Systemic Lupus Erythematosus
  • Systemic Lupus Erythematosus (SLE)
  • Cognitive Impairment

Interventions

DRUG

Placebo

The placebo will match the study drug in appearance, dose, and frequency. It will not contain any active drug (EG-501).

DRUG

EG-501

EG-501/ EG-MNTP-01 is an oral, low-affinity NMDA receptor antagonist.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Evergreen Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Leslie J. Crofford, M.D. · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2025-08-12
Completion
2025-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281105 on ClinicalTrials.gov