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Traumatic Brain Injury and Effects of Acute Cyclosporine A

NCT02496975 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-10-26

No results posted yet for this study

Summary

This is a prospective, randomized, placebo-controlled study about Cyclosporine A (CSP) and traumatic brain injury (TBI). Cyclosporine A is a drug already marketed and available for other diseases, but is not approved by the Food and Drug Administration for treatment of traumatic brain injury. The effect of Cyclosporine A on chemicals produced following brain injury is being determined using doses no larger than those used for patients having organ transplant. It is also being given for a much shorter time period (3 days). It is not know if side effects seen in patients taking cyclosporine A will occur when it is given for only 3 days. It is not known if patients with brain injury that are treated with cyclosporine A will have side effects like those seen in organ transplant patients.

Conditions

Interventions

DRUG

Cyclosporine A

Participants will receive 2.5mg/kg load then 5mg/kg qd continuous infusion x 3 days (72hours)

OTHER

Placebo

Participants will receive 2.5mg/kg load then 5mg/kg qd continuous infusion x 3 days (72hours)

Sponsors & Collaborators

  • Edward Hall,PhD

    lead OTHER

Principal Investigators

  • Edward Hall, PhD · Sponsor-Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-07
Primary Completion
2017-08-07
Completion
2017-08-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02496975 on ClinicalTrials.gov