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Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome

NCT03047980 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-11-01

Study results available
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Summary

The purpose of this research study is to gain a preliminary understanding of the safety of sirolimus in Sturge-Weber syndrome (SWS) and determine best outcomes to be used to assess the utility of sirolimus for the treatment of cognitive impairments related to Sturge-Weber syndrome.

Conditions

  • Sturge-Weber Syndrome

Interventions

DRUG

Sirolimus

Low dose oral sirolimus

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • Faneca 66 Foundation

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Anne Comi, MD

    lead OTHER

Principal Investigators

  • Anne M Comi, M.D. · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
31 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-06-04
Completion
2020-10-27

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03047980 on ClinicalTrials.gov