INTREPID-2566 is a research study to see if a new investigational drug called NNZ-2566 might help patients with traumatic brain injury (TBI).
The reasons for doing the study are:
- To see if NNZ-2566 is safe to give patients with TBI, and
- To see if NNZ-2566 can reduce the effects of the brain injury and help patients recover.
An investigational drug is one that is being tested for safety and effectiveness but has not yet been approved by the U.S. Food and Drug Administration (FDA) for doctors to prescribe to their patients. The FDA requires that new drugs be tested in research studies to prove that the benefits of the drug for potential patients outweigh the risks. The process whereby scientists obtain this proof is called drug development and involves testing in the laboratory, in animals, and finally in human patients. The INTREPID-2566 study is part of the drug development process for NNZ-2566. The study will find out if NNZ-2566 along with standard medical care is better than standard medical care alone in helping patients recover after a brain injury.
The long-term goal of the NNZ-2566 drug development research is to provide doctors with a safe and effective treatment for patients with traumatic brain injury.
The INTREPID-2566 study is sponsored by Neuren Pharmaceuticals Ltd, located in Auckland, New Zealand and funded in part by grants from the United States Army Medical Research and Materiel Command.
Important information about Exception From Informed Consent (EFIC)
In many emergency studies such as this one, it is necessary to give the experimental medication to the patient very soon after their injury in order for it to potentially help them. Due to the nature of traumatic brain injury, the patient is unable to provide their own consent, which in these instances is sought from a family member. The federal government realized that this was a problem for patients who potentially could have benefited from participating in a study, and for the researchers conducting such studies. The government made laws that allowed doctors to enroll patients in studies without first obtaining informed consent from a family member, but only in emergency situations and only if the doctor believed that the study could help the patient. These laws are called Exception from Informed Consent (EFIC) and are managed by the Food and Drug Administration (FDA). The INTREPID-2566 study will be conducted using exception from informed consent (EFIC).
The purpose of this website is to inform you about the INTREPID-2566 study and make you aware that patients may be enrolled into the study without the prior consent of a family member. Please read the information carefully and share your opinion by completing the online survey or contacting us using the online contact form.
If you suffer a brain injury and are taken to one of the participating hospitals you may be enrolled into the INTREPID-2566 study without your consent. If you do not want to be enrolled into the study you may opt-out now by registering in our Opt-Out Registry. You can reach the Opt-Out Registry by following this link.