Clinical Research Trials
Familial Intracranial Aneurysm (FIA) Study
The Familial Intracranial Aneurysm (FIA) study is a collaborative effort of physicians from throughout the United States, Canada, Australia, and New Zealand to identify genes that may be important in the development of aneurysms in the blood vessels of the brain. The FIA Study, is the largest study of the genetics of brain aneurysm in the world (currently more than 540 families). The study has made tremendous contributions to our understanding of why and in whom brain aneurysms form. This study of affected families is sponsored by the National Institutes of Health.
To be eligible to participate in this study, families must have two or more affected pairs of siblings (brothers/sisters) or 3 or more family members affected with intracerebral aneurysms. Participants are asked to complete a family history questionnaire and a medical history questionnaire. They also have their blood pressure measured and give a small sample of blood. In addition, certain family members are offered the opportunity to undergo a Magnetic Resonance Angiography MRA (a non-invasive diagnostic test) to look for undiagnosed brain aneurysms.
FIA I enrollment was completed in July 2007. Analysis of the genetic results is on-going and will be released in the spring of 2008. The study investigators have submitted to the National Institutes of Health for a continuation of the grant for an additional five years. This opportunity will allow for the enrollment of 300 additional families and 1200 persons with an intracranial aneurysm but no family history. These additional families and people without a family history will allow the study to replicate the genetic findings of FIA I, and to determine if the genetic findings are also present in people without a family history. You can follow the progress of this very important study, as well as the latest findings at the study website www.FIAStudy.org.
The Yale University School of Medicine, Department of Neurosurgery is conducting a study on the genetics of intracranial aneurysms called Genetics of Intracranial Aneurysm Trial (GIANT).Participation is easy and may be done entirely from your home. This study does not require a doctor’s visit or an appointment at Yale.
Participants will be sent a kit containing everything needed to be part of the study – clear and concise instructions, a consent form to sign and a special container to provide a saliva sample and a return mailer. No blood draw will be required.
This study is focused on identifying genes contributing to the formation and bleeding of brain aneurysms. The principal investigator, Dr Murat Gunel, and his team, have been conducting research into the causes of aneurysms for over a decade. The study is conducted under the auspices of the Yale University School of Medicine’s Human Investigation Committee. This study involves participants from both Finland and the US.
For further information on this study please contact Andrea Chamberlain at firstname.lastname@example.org or 1-800-299-9528.
About the NEWTON 2 Study
The pivotal, Phase 3 NEWTON 2 (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study is a multi-center, multi-national, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy and safety of EG-1962 to the standard of care oral nimodipine in adults suffering from an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm.
Patients in the experimental arm will receive a single 600 mg intraventricular injection of EG-1962 delivered via external ventricular drain plus placebo capsules or tablets administered for up to 21 days. Patients in the active comparator arm will receive a single dose of intraventricular normal saline and up to 21 days of oral nimodipine capsules or tablets. The primary outcome measure will be the proportion of patients with a favorable outcome of six to eight as measured on the Extended Glasgow Outcome Scale (GOSE) over 90 days. Additional outcome measures are neurocognitive outcome at Day 90 measured by the Montreal Cognitive Assessment (MoCA), safety (including delayed cerebral infarction at Day 30) and health economic endpoints.
EG-1962 is a novel polymeric nimodipine microparticle suspended in a diluent of hyaluronic acid created by Edge Therapeutics’ proprietary PrecisaTM development platform and designed to improve patient outcomes following an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm. EG-1962 has been granted orphan drug designation and Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with subarachnoid hemorrhage, and orphan drug designation by the European Commission (EC) for the treatment of patients with aSAH.
Other Current Research Studies
For more information on clinical trials in your area, please visit clinical trials.