Clinical Trials at the MFA:

TITLE DESCRIPTION
A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS) This is a study to assess for musculoskeletal symptoms through physician evaluation and QOL forms.
A Hookworm Infection Study in Healthy Adults This study is being conducted to determine the optimal dose of infectious hookworm larvae that is safe to give to healthy adults, and that leads to an infection with adult worms in the intestine. Hookworm is a parasitic worm that can live for several years in the intestine of humans, feeding on the blood of the people they infect. Study participants will provide routine stool and blood samples and will receive anti-worm medication 3 months from application of the larvae to treat the infection. This study is looking to enroll males or females, 18-45 years of age in good general health, who are available for the duration of the study (6 months). Subjects must be HIV, Hep-B and Hep-C negative.
A multicenter, global, observational study to collect information on safety and to document the utilization of Tecifidera when used in routine medical practice in the treatment of multiple sclerosis (ESTEEM) To gain a better understanding of the benefits and risks of long-term treatment with Tecifidera in patients with multiple sclerosis
A multicenter, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of SA237 as monotherapy in patients with neuropyelitis optica (NMO) To evaluate the effectiveness and safety of under the skin injection of SA237 as monotherapy in patients with NMO.
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. This is a randomized trial to determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS-25 or less) by Oncotype DX®.
A Phase III, Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer Men with newly diagnosed metastatic hormone sensitive prostate cancer and a PSA =2 ng/mL with be randomized to either Androgen deprivation therapy (LHRHa) + TAK-700 (ARM 1) or Androgen deprivation therapy (LHRHa) + Bicalutamide (ARM 2, also the standard of care arm). Patients will be followed for 10 years.
Acromegaly Safety Monitoring Program An Acromegaly Safety Monitoring Program for Treating Patients with Pasireotide LAR who are in need of Medical Therapy (ACCESS Study)This study will provide acromegalic patients, for whom medical therapy is appropriate, access to paseriotide LAR while regulatory approval is sought. Potential patients must: -be age 18 or older -have confirmed diagnosis of active acromegaly (caused by GH producing pituitary tumor) -not be controlled by pituitary surgery or not be eligible or refuse surgery
Assessment of Deep Gray Matter changes in Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Gilenya To compare the brain MRI volumetric analysis of brain gray matter to its correlation with impaired cognitive function in patients with RRMS
BioSET Prefix Study THis study is designed to evaluate the safety and preliminary effectiveness of one coating concentration of Prefix compared to iliac crest bone in approximately 22 skeletally mature subjects diagnosed with degenerative disc disease (DDD) at one vertabral level (L2-S1)
Blood Loss during fibroid surgey Use of Intravenous Tranexamic Acid during Myomectomy: A Randomized Double-Blind Placebo Controlled Trial The goal of this study is to help us learn more about the ability of a drug called tranexamic acid to reduce blood loss and the need for a blood transfusion that occurs during a myomectomy (fibroid surgery). Tranexamic acid is approved for patients undergoing cardiac, knee and hip surgery by the FDA but yet not approved for the indication of myomectomy surgery as being investigated in this study. The research team would like to enroll healthy women between 18 and 50 years of age; with no history of blood clots in the legs or lungs, heart attack, stroke or kidney disease and scheduled for an abdominal, laparoscopic or robotic myomectomy at George Washington University Hospital.
Combination immunotherapy with Herceptin and the HER2 vaccine E75 in low and intermediate HER2- expressing breast cancer patients to prevent recurrence This is a randomized trial for after all neo or adjuvant therapy is complete for women are Her2 1+ or HER2 2+
Controlled Trial of Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) The goal of this study is to complete the first definitive controlled trial of a neurosurgical procedure for a severe psychiatric illness. The study will compare the effects of three months of double-masked placebo versus active DBS on OCD severity. Potential participants must: -be between the ages of 18 and 75 -have OCD diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV) -have persistence of sever symptoms and impairment for five years or more despite at least three first-line and two second-line treatments.
DuraSeal Exact Spine Sealant System Post-Approval Study This multi-center, non-randomized, two-arm, Post Approval Study will further evaluate the rate of postoperative CSF leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant for treatment of either an intentional or incidental opening of the dura compared to Control patients who receive other products and/or treatments to close the dura. Subjects must be 18 years of age or older and have had a spinal procedure where a dural opening (whether intentional or incidental) occured and was treated with either: -DuraSeal Exact Spine Sealant System (DuraSeal Sealant arm ONLY) or - Any other method of sealing the dura with the exception of DuraSeal Sealant- either spinal or cranial (Control arm ONLY)
E1305: A Phase 3, Randomized Trial of Chemotherapy with or without Bevacizumab with Recurrent or Metastatic Head and Neck Cancer The purpose of the study is to find out whether adding a new drug (Bevacizumab) to the standart platinum-based chemotherapy will help improve the survival of patients whose head and neck cancer has either returned after chemotherapy or spread throughout the body.
E2112-A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating postmenopausal patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes or another place in the body. Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.
Investigational drug study (ipilimunab) for prostate cancer A Phase 2, Double-Blind Study of Ipilimumab Administered at 3mg/kg vs 10mg/kg in Adult Sujbects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic. The primary objective of this study is to estimate the radiographic progression-free survival of patients with chemotherapy-naïve castrate resistant prostate cancer patients randomized to ipilimumab 3mg/kg vs 10mg/kg
Low frequency electrical stimulation of the fornix in Intractable Mesial Temporal Lobe Epilepsy (MTLE) To develop a protocl to evaluate the safety and tolerability of low frequency stimulation of the fornix in patients with MTLE.
Multiple sclerosis - use of Tecifidera and Rebif A prospective open label study evaluating treatment satisfaction in subjects with relapsing remitting multiple sclerosis following treatment change from Tecifidera to Rebif. To deermine patient satisfaction with Rebif compared to Tecfidera in regards to Rebif's overall effectiveness, any side effects and convenience (for relapsing form of multiple sclerosis)
New experimental drug treatment for prostate cancer ARN-509-003: A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with non-Metastatic (M0) Castration-Resistant Prostate Cancer This is a randomized (2:1) trial evaluating the safety and efficacy of ARN-509 versus placebo in men with high risk (M0), non-metastatic castraction resistant prostate cancer (NM-CRPC), defined as PSA doubling time (PSADT) = 10 months
New experimental treatment for thrombocytopenia PAC326: A Randomized, Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythermia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis This study will find out if an experimental drug called pacritinib works better than best available therapies.
New Look at Type 2 Diabetes - Effect of Saxagliptin as a cellular biomarker for evaluating Endothelial Dysfunction in Early Type 2 Diabetes Patients The primary objective of this study is to ascertain if saxagliptin improves endothelial dysfunction in early type 2 diabetes patients. We are looking for patients with Type 2 Diabetes who have no major complications and hemoglobin A1C between 6.0% and 9.0%. Patients also need to be taking Metformin for their diabetes but NOT insulin. This study will take place over four months and include a total of four visits to the MFA. Potential patients must be between the ages of 40 and 70 years old, have Type 2 Diabetes, be taking metformin ONLY for diabetes for at least 3 months, have a Hemoglobin A1C greater than or equal to 6.0% and a Body Mass Index (BMI) between 25.0 and 40.0.
New treatment approach for high risk prostate cancer patients A Randomized Phase III Trial of Neo-Adjuvant Docetaxel and Androgen Deprivation prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer This randomized trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.
New treatment approach for multiple myeloma CC4047-MM-007: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidamide, Bortezomib and Low-Dose Dexamethasone versus Bortezomib and Low-Dose Dexamethasone in subjects with Relapsed or Refractory Multiple myeloma The purpose of this study is to see how well the combination of pamalidomide, bortezomib and dexamethasone works compared to the combination of bortezomib and dexamethasone.
Photodynamic Therapy for Papulopustular Rosacea Dermatology at The GW Medical Faculty Associates is conducting an experimental research study to examine the efficacy of 5-aminolevulinic acid photodynamic therapy (5-ALA PDT) in treating rosacea. The purpose of this study is to evaluate if using 5-ALA PDT improves rosacea symptoms. We are seeking individuals with rosacea between the ages of 18 and 79 to volunteer to participate in this study. This study will take a total of six months (six total visits to the MFA). Prior to each visit, you will be examined and fill out a questionnaire. Participation in the study will be of no direct cost to you. If you are interested in participating in this research study, please contact Dermatology at The GW Medical Faculty Associates.
Prospective Study to Evaluate the Lateral Lumbar Interbody Fusion Surgical Approach (LLIF Prospective Study) The objective of this study is to gather clinical data and satisfaction ratings from patients who have undergone the MIS LLIF surgical approach using the Patriot TransContinental, CALIBER-L or INTERCONTINENTAL LLIF Spacer and REVOLVE Stabilization System for qualifying patients with 1-2 contiguous levels of degenerative disc disease (L2-S1) with mechanical low back pain and radicular symptoms. A total of 45 patients between 18 and 80 years of age will be enrolled and followed for 2 years with data collection preoperatively and postoperatively.
Responsive Neurostimulator System (RNS) Long Term Treatment Investigation This study os designed to assess the ongoing safety and to evaluate the long-term effectiveness of adjunctive RNS therapy in reducing siezures that are refractory to two or more antiepileptic medications.
Retrospective Study to Assess the lateral Lumbar Interbody Fusion (LLIF) Surgical Approach (LLIF Retrospective Study) This will be a retrospective clinical study involving 80 patients that underwent Lateral Lumbar Interbody Fusion and Posterior Pedicle Screw Fixation using the PATRIOT TransContinental or CALIBER-L LLIF Spacer and REVOLVE or REVERE Stabilization Systems.
Role of Linagliptin in improving renal failure by improving CD34+ stem cell number, function and gene expression in renal function impaired type 2 diabetes patients. The primary objective of this study is to ascertain if Linagliptin improves endothelial dysfunction in early type 2 diabetes patients with impaired renal function. We are looking for patients with Type 2 Diabetes who have no major complications, and a hemoglobin A1C between 6.5% to 9.0%. Patients need to have chronic kidney disease (CKD) stages 1-3, and being taking Metformin, Insulin, or both for their diabetes. This study will take place over 16 weeks, and includes a total of four visits to the MFA. Potential patients must be between ages 40 and 70 years old, have Type 2 Diabetes, have stage 1-3 kidney disease, be taking metformin or insulin (or both) for diabetes for at least 3 months, have a hemoglobin A1C greater than or equal to 6.5%, and a Body Mass Index (BMI) between 25.0 and 40.0
S0931:A Phase III Trial of Everolimus for Renal Cell Ensuing Surgical Therapy This study is for renal cancer patients who have undergone full surgical resection (radical nephrectomy or partial nephrectomy). Patients must be considered pathologically either intermediate hight risk or very high risk for recurrence.
Severe atopic dermatitis A Phase 3 Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients with Moderate to Severe Atopic Dermatitis / Liberty AD Solo (R668-AD-1416)This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with maderate to severe AD. The study is either 16 weeks (16 week treatment period) or 28 weeks (16-week treatment period and 12-week follow up), depending on whether or not patients continue in a maintenece or extension study.
Sonography-Guided Transcervical Ablation of Uterine Fibroids (SONATA) The SONATA Study is an FDA-approved clinical study designed to establish the safety and effectiveness of a new, investigational device to reduce heavy menstrual bleeding caused by uterine fibroids. The device, called the SONATA System, targets fibroids rather than treatment or removing the entire uterus. If effective, this device will provide an alternative to hysterectomy that is: incision-free, preserves the uterus, does not require general anesthesia and is an outpatient procedure.
Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis (SIMM) The aim of the study is to evaluate Subcutaneous immunoglobulin (SQIg) therapy in patients with generalized Myasthenia Gravis to determine over a 6 month period whether the compound has corticosteroid sparing effects. The study is also looking to determine the safety profile of SQIg for long term therapy of MG patients.
Treatment with pregabalin for chronic post-traumatic nerve pain A Randomized, double-blind placebo controlled study of the efficacy and safety of pregabalin in subjects with post-traumatic peripheral neuropathic pain To assess the safety and eficacy of pregabalin treatment of patients with chronic post-traumatic peripheral neuoropathic pain
Use of a patch for a Chalazion (Stye on the eye) A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN 131 Transdermal System Patch as Compared to Placebo in Adult Patients With a Chalazion (red bump on eyelid or "Stye") Subjects will be randomly assigned to receive either SUN-131 1.5% Patch or Placebo Patch for the affected eye. All patches will be worn for 16±4 hours each day for 21 days.
X05383: Retrospective Study to Evaluate the Incidence and Severity of Peripheral Neuropathy in Relapsed/Refractory Mulitple Myeloma Patients Retreated with Bortezomib Determining the incidence and change in severity of peripheral neuropathy upon retreatment of multiple myeloma patients with bortezomib as compared to initial bortezomib treatment