Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT05734404

Conditions

Central Nervous System Vasculitis

CNS Vasculitis

CNSV

Vasculitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. The purpose of this study is to establish a research cohort to investigate the disease process, treatments, and patient outcomes in CNSV.

Conditions

Central Nervous System Vasculitis

CNS Vasculitis

CNSV

Vasculitis

Study ID

NCT05734404

Start date

Mar 1, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

i. Diagnostic criteria for CNSV

1. The presence of an acquired and otherwise unexplained neurologic deficit
2. The presence of either classic angiographic or histopathologic features of angiitis in the CNS
3. No evidence of systemic vasculitis or any condition that could cause the angiographic or pathologic features

ii. ≥18 years of age

Exclusion Criteria:

i. Unwilling to sign informed consent.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Evaluate the pathogenesis of central nervous system vasculitis using disease history. [ Time Frame: Study completion; from baseline through month 36. ]

Central Contacts and Locations

Central contacts

Carol McAlear

7813214567cmcalear@upenn.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jenni Sletten

Sletten.Jennifer@mayo.edu

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Brittany McKnight

mcknigb@ccf.org

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jessica Nguyen

Jessica.Nguyen2@PennMedicine.upenn.edu

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Pamela Schlairet

pamela.schlairet@vumc.org

St. Joseph's Healthcare

Recruiting

Hamilton, Canada

Contacts

Sandra Messier

smessier@stjosham.on.ca

University of Toronto/Sinai Health

Recruiting

Toronto, Canada

Contacts

Nazrana Haq

Nazrana.Haq@sinaihealth.ca

More Information

Sponsor

University of Pennsylvania

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-01-23.