Clinical Trials

Beaumont Health System, with three hospitals in the northern Detroit suburbs serving southern Michigan and beyond, is a highly productive contributor to clinical trials across the nation. The Beaumont Research Institute, established by the hospital’s Board of Trustees in 1966, strengthens Beaumont's ability to conduct medical research and to provide a research training experience for the medical staff and participants in graduate medical education programs.

[RTOG 0933] A PHASE II TRIAL OF HIPPOCAMPAL AVOIDANCE DURING WHOLE BRAIN RADIOTHERAPY FOR BRAIN METASTASES

Status: open and enrolling

Approval Date: 4/25/2012

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.  PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases.


A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of VP 20621 for Prevention of Recurrence of Clostridium Difficile Infection (CDI) in Adults Previously Treated for CDI

Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection

Status: closed

Approval Date: 4/20/2012

The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.


[PROTOCOL 12649A] A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP PLACEBO-CONTROLLED PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DESMOTEPLASE IN SUBJECTS WITH ACUTE ISCHEMIC STROKE (DIAS 4)

Status: open and enrolling

Approval Date: 4/16/2012

Acute stroke is a major cause of mortality and long-term disability in the developed world.  The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (tPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of causing intracerebral hemorrhage; consequently fewer than 3% of acute stroke subjects are treated.  The thrombolytic agent desmoteplase, the study medication, produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat. Compared to alteplase, desmoteplase has a more favorable profile in terms of high fibrin specificity and non neurotoxicity.  The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.


ACE: AN ANEURYSM COILING EFFICIENCY STUDY OF THE PENUMBRA COIL 400 SYSTEM - Protocol CLP 4492

Status: open and enrolling

Approval Date: 4/13/2012

This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.


A SINGLE-BLIND, MULTI-SITE TRIAL OF THE DIETARY SUPPLEMENT ANATABINE (RCP006) TO DETERMINE THE EFFECTS ON PERIPHERAL MARKERS OF INFLAMMATION IN PATIENTS WITH ELEVATED LEVELS OF C-REACTIVE PROTEIN (CRP)

Effect of Anatabine on Elevated Blood Levels of C-reactive Protein

Status: open and enrolling

Approval Date: 4/12/2012

The investigators are studying a dietary supplement called anatabine in a lozenge form named RCP006. The main purpose of this study is to evaluate the effects of this dietary supplement on normal human inflammatory function. The investigators will see this effect in volunteers who have markers of higher levels of inflammation to begin with. The investigators anticipate that anatabine will reduce markers of inflammation. Therefore the investigators are looking for volunteers with high blood levels of C-reactive Protein (CRP) and will monitor the blood CRP levels at several time points throughout the study.