Traumatic Brain Injury and Effects of Acute Cyclosporine A

• Status: Withdrawn
• Trial end date: 2017-08-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edward Hall,PhD
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Participant is between the ages of 18 and 65

• Participant speaks and understands English

• CT Scan evidence of severe TBI

• Post resuscitation GSC 4-8 with at least one reactive pupil

• motor score of greater than 5

• Study medication will be administered within 8 hours injury

Exclusion Criteria:

• Participant received high dose systemic corticosteroids, such as Methylprednisolone >15 mg/kg or equivalent,

• Participant has a known allergy to cyclosporine A,

• Participant is pregnant,

• Participant is less than 18 years of age or greater than 65 years of

• Participant has a history of kidney problems, history of stroke or spinal cord injury,

• Participant has a history of cardiovascular disease, or use of immunosuppressive therapy in the last three months,

• Participant has a history of malignant tumors unless they have been in remission at least five years.

• Participant has an active infection

• Participant has taken part in another investigational trial within the last 30 days.