CLINICAL TRIALS CURRENT STUDIES: The following studies are screening interested participants now.
Protocol Number: H06-018 - Approval Date: 8/8/2005

  STUDY PRINCIPAL INVESTIGATOR

CONTACT
  ADULT BIPOLAR 1 DEPRESSION    
  BIPOLAR I DEPRESSION
An eight week study evaluating the safety and efficacy of an investigational medication in adults with Bipolar I Depression
  • Must be 18 to 65 years of age
  • Must be diagnosed Bipolar I Disorder, Most Recent Episode Depressed
  • Must have a history of two or more manic of mixed episodes, and at least one of these episodes with documented pharmacological treatment for manic symptoms
  • Must not currently be manic, hypomanic or mixed episode
  • Must not be diagnosed Bipolar Disorder with Rapid Cycling within past twelve months
LSUHSC-S IRB Approved 2/9/09; Protocol #:H09-089
Dr. Anita Kablinger Barbara Roggero
Phone: (318) 813-2070 or
1/866/779-2546
Email: brogge@lsuhsc.edu
  ALZHEIMERS STUDIES    
  ELAN 301 and 302: A Phase III, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Trial of Bapineuzumab in Patients with Mild to Moderate Alzeheimer's Disease who are Apolipoprotein E4 Non-Carriers (ELAN301) and are Apoliproprotein E4 Carriers (ELAN 302)
IRB #H08-098 - Approval Date: 1/16/08 		Dr. Roger Kelley Pat Jinkins, Coordinator
Phone: (318) 813-1481
Email:pjinki@lsuhsc.edu
  ALZHEIMER'S Disease
A 23 month study on an investigational secretase inhibitor on the progression of Alzheimer's Disease as compared with placebo.

Study participant must:
  • Must be at least 55 years of age
  • Meet criteria for probable to moderate Alzheimer's Disease
  • Must have a reliable caregiver who can accompany patient to all study visits
  • Must not have a serious or unstable illness
  • Must be able to swallow whole oral medications

IRB#: #H-09-053 - Approved: 11/11/08

 James Patterson, MD, PhD Barbara Roggero
Phone: (318) 813-2070 or
1/866/779-2546
Email: brogge@lsuhsc.edu
  CARDIOVASCULAR STUDIES    
  CARDIOVASCULAR (CRESCENDO): "Comprehensive Rimonabant Evaluation Study of Cardiovascular Endpoints and Outcomes, Randomized, Multi-national, Multi-center, Double-blind Placebo-controlled, two-arm parallel group trial of rimonabant 20mg OD for reducing the risk of major cardiovascular events in abdominally obese patients with clustering risk factors."
IRB #H06-066 - Approval Date: 12/19/05		 Dr. Roger E. Kelley Sarah Bezucha, Coordinator
Phone: (318) 813-1456
Email:sbezuc@lsuhsc.edu
  CHILD AND ADOLESCENT BIPOLAR DISORDER    
 

CHILD AND ADOLESCENT BIPOLAR DISORDER
 A 12 month study on Lamictal as add-on maintenance treatment in Bipolar Disorder as compared with placebo

  • Must be 10 to 17 years old
  • Must have a Bipolar diagnosis
  • Must not be diagnosed with another Axis I disorder (Except ADHA, Anxiety D/O, ODD, Conduct D/O)
  • Must be currently receiving a stable treatment reginmen for Bipolar I

IRB #H09-043; LSUHSC-S IRB Approved: 9-29-08

 Dr. Anita Kablinger Barbara Roggero
Phone: (318) 813-2070 or
1/866/779-2546
Email: brogge@lsuhsc.edu
  DIABETES AND CARDIOVASCULAR STUDY    
  DIABETIC KETOACIDOSIS:
Normasol vs. Versus Normal Saline Diabetic Ketoacidosis.
IRB #H06-104 - Original approval: 3/27/06 		Dr. Simon Mahler Kimberly Hutchinson
Phone: (318) 675-6682
Email: ksmit9@lsuhsc.edu
  EPILEPSY/SEIZURE STUDIES    
  Protocol 1280 - A Multi-center, Double-blind Historical Control Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Seizures
IRB #H08-014 - Approval Date: 8/27/07 		Dr. Rosario Riel-Romero Sarah Bezucha, Coordinator
Phone: (318) 813-1456
Email:sbezuc@lsuhsc.edu
  OV1012: A Double-blind, Placebo Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5, 1.0 mg/kg.day) in patients with Lennox-Gastaut Syndrome.
IRB #H08-038; Approval Date: 12/4/07 		Dr. Rosario Riel-Romero Sarah Bezucha, Coordinator
Phone: (318) 813-1456
Email:sbezuc@lsuhsc.edu
  HEPATITIS    
  HEPATITIS C:SCH 503034
In previously untreated subjects with chronic hepatitis C infected with genotype.
IRB Protocol #H07-054 - Approval Date: 1/16/07 		Dr. John King Dana Favot, RN
Phone: (318) 675-5902
Email: dfavro@lsuhsc.edu
  KIDNEY DISEASE    
  CHRONIC KIDNEY DISEASE:
A Study for Patients 18 Years of Age or Older With Chronic Kidney Disease. TID PO Treatment for the Prevention of CKD Progression in Patients With Moderate to Severe CKD. Includes Quality of Life Assessments.
IRB Protocol #H07-108 		Dr. Joan Blondin Twyla Balentine, RN, CCRC
Phone: (318) 675-5595
Email: tbalen@lsuhsc.edu
  LUPUS STUDIES  
  The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study.
Protocol #SL105 - Approval Date: 5/19/08. 		Dr. Seth Berney Denise Shewmake
Phone: (318) 675-5585
Email: sshewm@lsuhsc.edu
  MIGRAINE STUDY    
  A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Controlled, Crossover Study to Evaluate the Efficacy of TREXIMA (Sumatriptan + Naproxen Sodium) versus Butalbital-Containing Combination Medications for the Acute Treatment of Migraine when Administering during the Moderate-Severe Pain Phase of the Migraine.
IRB #H08-100 - Approval Date: 1/16/08 		Dr. Debra Elliott Pat Jinkins, Coordinator
Phone: (318) 813-1481
Email:pjinki@lsuhsc.edu
  TEMPUS - Tonabersat Evaluation in Migrane Prevention in the US
IRB #H08-017 - Approval Date: 8/27/07 		Dr. Debra Elliott Pat Jinkins, Coordinator
Phone: (318) 813-1481
Email:pjinki@lsuhsc.edu
  MULTIPLE SCLEROSIS    
  CONFIRM: A placebo-controlled study comparing a new oral drug for MS (BG00012) to Copaxone for patients with relapsing-remitting multiple sclerosis with at least one relapse in the past 12 months and an MRI proving lesions consistent with MS. Study drug or (placebo) is free of charge for the duration of this two year study.
IRB #H08-011		 Dr. Alireza Minagar Katy Chalamidas, Coordinator
Phone: (318) 813-1452
Email: kchala@lsuhsc.edu
  CARE-MS-1: A study comparing alemtuzumab to Rebif in patients who are previously untreated for relapsing-remitting multiple sclerosis with at least one relapse in the past 12 months and an MRI proving lesions consistent with MS. Study drug (or placebo) is free of charge ot the patient.
IRB#H08-075 		Dr. Alireza Minagar Katy Chalamidas, Coordinator
Phone: (318) 813-1452
Email: kchala@lsuhsc.edu
  CARE-MS-2: A study comparing alemtuzumab to Rebif in patients who are previously untreated for relapsing-remitting multiple sclerosis who have had relapses on other MS medications. Study drug (or Rebif) will be provided to study participants free of charge for the duration of this two year study.
IRB#H08-077		 Dr. Alireza Minagar Katy Chalamidas, Coordinator
Phone: (318) 813-1452
Email: kchala@lsuhsc.edu
  ORTHOPEDIC STUDIES    
  PRIMARY ELECTIVE KNEE ARTHROPLASTY Protocol Number: CONSUI-US01: A Phase IIb, Double-blind, Double-dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of YM150 in Subjects Undergoing Primary Elective Knee Arthroplasty ISN 150-CL-033.
IRB #H08-039 - Approval Date: 10/26/07 		Dr. Lucas Anissian

Deborah Hendricks, RN
Phone: 318/675-8320
dhendri@lsuhsc.edu

  PARKINSON DISEASE STUDIES  
 

A Ramdomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6mg BID) in Patients with Early Parkinson Disease
IRB #H09-097; Approval Date: 2/24/09; NCT00809302

Dr. Richard Zweig Colette Hilliard, MS, CCRC
Phone: (318) 675-8157
Email:chilli@lsuhsc.edu
  Effects of Coenzyme Q10 in Parkinson's Disease-Phase III (QE3): The objective of this study, called 'QE3' is to evaluate the safety and effectiveness of high dosages of CoQ in slowing clinical decline in people who have early Parkinson's disease. CoQ is a naturally occurring substance in the body and is also a nutritional supplement. In previous studies CoQ has been well tolerated.
IRB #H08-134 - Approval Date: 6/2/08; NCT00740714 		Dr. Richard Zweig Colette Hilliard, MS, CCRC
Phone: (318) 675-8157
Email:chilli@lsuhsc.edu
  PROGENI:
Parkinson's Research: The Organized Genetics Initiative.
IRB #H06-149 - IRB Approval Date: 6/26/06; NCT00086073 		Dr. Richard Zweig

Colette Hilliard, MS, CCRC
Phone: (318) 675-8157
Email:chilli@lsuhsc.edu
  PD LS-1:
A Multi-center, Double blind, Parallel Group, Placebo Group, Placebo-controlled Study of Creatine in Subjects with Treated Parkinson's Disease (PD) LS-1.
IRB #H07-033 - Approval Date: 9/26/06; NCT#00449865 		Dr. Richard Zweig Colette Hilliard, MS, CCRC
Phone: (318) 675-8157
Email:chilli@lsuhsc.edu
  PEDIATRIC OBSERVATION STUDY    
  A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated with Deferasirox
IRB #H07-101 		Dr. Majed Jeroudi Pepper Lumina
Phone: (318) 675-4740
Email: PLumin@lsuhsc.edu
  PEDIATRIC PAIN    
 

TRAMAPPAI1002 - A Single Dose Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER® at Two Dose Levels in Children Seven to Eleven Years Old, Inclusive, with Pain.
IRB #H08-050

Dr. Margaret Ann Springer Lora Todd
Phone: (318) 675-5078
Email:ltodd@lsuhsc.edu
 

TRAMAPPAI1003 - A Single Dose Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER® at Two Dose Levels in Adolescents Twelve to Seventeen Years Old, Inclusive, with Pain.
IRB #H08-051

Dr. Margaret Ann Springer Lora Todd
Phone: (318) 675-5078
Email:ltodd@lsuhsc.edu
  PULMONARY STUDIES    
  PARINGENIX COPD study to evaluate Intravenous 2-0, 3-0 desulfated heparin in subjects requiring hospitalization with COPD exacerbations.
IRB #H07-087 - Approval Date: 3/19/2007		 Dr. Gerry San Pedro Deborah Hendricks
Phone: (318) 675-8320
Email: dhendr@lsuhsc.edu
  RENAL CELL TRIAL    
  WILEX Pharmaceuticals: A randomized double-blind Phase III study to evaluate adjuvant cG250 treatment versus placebo in patients with clear cell RCC and high risk of recurrence.
Protocol #H05-107 - Approval Date: 7/26/05		 Dr. Donald Elmajian Kacey Langley Arnold, CCRP
Phone: (318) 675-5655
Email:karnol@lsuhsc.edu
  SCHIZOPHRENIA STUDIES    
  ADULT SCHIZOPHRENIA, CAMP: Comparison of Antipsychotics for Metabolic Problems
A 6 month study switching to Abilify versus Continued Treatment with Zyperxa, Risperdal, and Seroquel.
  • Must be 18 to 65 years of age
  • Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Must be taking Zyprexa, Seroquel, or Risperdal for at least 3 months
  • Must have a BMI > 27
  • Must not be in their first episode of schizophrenia
Protocol #H07-038 - Approval Date: 9/25/06
Dr. Anita Kablinger Barbara Roggero
Phone: (318) 813-2070 or
1/866/779-2546
Email: brogge@lsuhsc.edu
  ADOLESCENT SCHIZOPHRENIA
A 24 month study on Paliperidone ER
  • Must be 12 to 17 years of age
  • Must be experiencing symptoms that may include: having strange thoughts, unusual experiences, or changes in behavior or mood
  • Must have been treated with psychiatric medication in the last one year
  • Must not have Schizoaffective Disorder, Major Depressive Disorder or Bipolar Disorder
Protocol #H07-115 - Approval Date: 4/30/07 		Dr. Anita Kablinger Barbara Roggero
Phone: (318) 813-2070 or
1/866/779-2546
Email: brogge@lsuhsc.edu
  SEVERE SEPSIS STUDY
   
  ACCESS:
A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients with Severe Sepsis.
IRB #H06-151 - Original approval: 8/7/06 		  Kimberly Hutchinson
Phone: (318) 675-6682
Email: ksmit9@lsuhsc.edu
  STROKES STUDIES    
  ALIAS: A Randomized, Multi-center, Double-blind study measuring the efficacy of Albumin for decreased brain trauma in patients suffering from an acute ischemic stroke.
IRB #H06-100 - Approval Date: 3/27/06
Dr. Roger E. Kelley Sarah Bezucha, Coordinator
Phone: (318) 813-1456
Email:sbezuc@lsuhsc.edu
 

WARCEF STROKE PREVENTION:
Stroke prevention in subjects with congestive heart failure. Ejection Fraction (EF) must be 35% or below. Study meds include warfarin/placebo or aspirin/placebo. There is no cost to the patient. Medication is regulated by blood collections at intervals determined by the study physician. Joint Neurology and Cardiology investigation.
IRB # H-02-020

 Dr. Roger E. Kelley Pat Jinkins, Coordinator
Phone: (318) 813-1481
Email:pjinki@lsuhsc.edu
  (IRIS):
Study for patients who have experienced a recent stroke (within the past 6 months) and who are insulin resistant (determined by a blood test). There will be no cost for study medication (pioglitazone or placebo) or for study visits.
IRB #H05-065 - IRB Approval Date: 9/27/05 		Dr. Alireza Minagar Katy Chalamidas, Coordinator
Phone: (318) 813-1452
Email: kchala@lsuhsc.edu
  URINARY INCONTINENCE    
  URINARY INCONTINENCE IN FEMALES (Protocol #CONSUI-US01): A Single-masked, Randomized, Multi-center, 2-arm Parallel Study Comparing the Safety and Effectiveness of Bulkamid and Contigen as Bulking Agents for the Treatment of Stress Urinary Incontinence in Females.
IRB# H08-039 - Aproval Date: 8/19/08 		Dr. Alexander Gomelsky Twyla Balentine, RN, CCRC
Phone: (318) 675-5595
Email: tbalen@lsuhsc.edu
  OTHER STUDIES    
  (ADOPT): A Phase 3, Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization. Sponsor: Bristol Myers Squibb. June 2007 - Present.
IRB #06-160 - Original Approval Date: 6/26/06		 Dr. Steven Conrad Kimberly Hutchinson
Phone: (318) 675-6682
Email: ksmit9@lsuhsc.edu
  "A Comparison of Anavip® [Crotalinae (pit viper) equine immune F(ab)2 ] and CroFab® (Crotalidae Polyvalent Immune Fab, ovine) in the Treatment of Patients with Crotalinae Envenomation: A Randomized Prospective, Blinded, Controlled, Comparative, Multi-center Study", (Anivip). Sponsored-Instituto Bioclon S.A. de C.V. May 2008-present.
IRB #H08-124 - Original Approval Date: 3/19/08 		Dr. Thomas Arnold Kimberly Hutchinson
Phone: (318) 675-6682
Email: ksmit9@lsuhsc.edu
  ROBUST: An observational study monitoring the results of those recently put on Betaseron. The study drug is NOT provided as this is an observational study only.
IRB #H08-008 		Dr. Alireza Minagar Katy Chalamidas, Coordinator
Phone: (318) 813-1452
Email: kchala@lsuhsc.edu
  Injuries Produced by Law Enforcement Use of Less Lethal Weapons: A Prospective Multi-center Trial.
IRB #H05-173 - Original approval 5-11-05		 Dr. Derell Graham Kimberly Hutchinson
Phone: (318) 675-6682
Email: ksmit9@lsuhsc.edu
 

FEIST WEILLER CANCER CENTER STUDIES
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http://www.feistweiller.org/clinical-trials/cancer_treatment_studies.cfm