Traumatic Brain Injury and Effects of Acute Cyclosporine A

NCT02496975 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 14-0469-F6A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Serum lipid peroxidation products: isoprostanes and neuroprostaneses measured by gas-chromatography with mass spectometry

  Serum lipid peroxidation products will be measured by gas-chromatography with mass spectometry

  first 7 days after TBI

• Cerebrospinal fluid (CSF) calpain-mediated cytoskeletal breakdown products measured by western blotting

  cytoskeletal breakdown products will be measured by western blotting

  first 7 days after TBI

Secondary Outcomes (1)

• ICP Therapy Intensity Level (TIL) Summary

  first 7 days after TBI

Study Arms (2)

Cyclosporine A

EXPERIMENTAL

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

Drug: Cyclosporine A

Placebo

ACTIVE COMPARATOR

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

Other: Placebo

Interventions

Cyclosporine A DRUG

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

Cyclosporine A

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edward Hall,PhD: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• Hatton J, Rosbolt B, Empey P, Kryscio R, Young B. Dosing and safety of cyclosporine in patients with severe brain injury. J Neurosurg. 2008 Oct;109(4):699-707. doi: 10.3171/JNS/2008/109/10/0699.

  PMID: 18826358 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Edward Hall, PhD

  Sponsor-Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: July 14, 2015
• Study Start: August 7, 2017
• Primary Completion: August 7, 2017
• Study Completion: August 7, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)