Clinical Trials


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		The Department of Neurology is actively involved in clinical trials to determine the effectiveness of new medications to treat neuromuscular diseases and disorders. If you are interested in receiving additional information or participating in a trial, please e-mail or call the persons listed below. Please note that enrollment is currently closed for some of the trials. ALS Cervical Dystonia Diabetic Neuropathy Trials listed on our Neuropathy Web Site Epilepsy Movement Disorders/Parkinson's Disease Multiple Sclerosis - Ongoing trials Multiple Sclerosis - Completed trials for historical reference Myasthenia Gravis Myotonic Dystrophy and Heart Rhythm Disorders Peripheral Neuropathy Stroke ALS Trials Celebrex for ALS Enrollment is closed. Not accepting new patients. This study compares the effect of celebrex versus an inactive pill (placebo) in slowing the progression of Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig's disease). It is part of a multicenter trial by Northeast Amyotrophic Lateral Sclerosis (NEALS) consortium. Celebrex is a new anti-inflammatory medication. It has been shown in the cell cultures to decrease the toxic effects of glutamate on the nerve cells and also to increase survival in the mouse model of ALS. The study will continue for one year and patients will be evaluated every 2 months; each visit will last about 2 hours. Potential benefit of participation in the study is slowing of progression of the disease. Celebrex will be provided to all participants after the completion of study until the results of the study are available. Principal investigator: Kourosh Rezania, MD Co-investigators: Betty Soliven, MD and Raymond Roos, MD Study coordinator: Pamela Phillips, RN, BSN at (773) 702-6221 BNDF for ALS Study completed. Enrollment is closed. Prinicipal investigator: Raymond Roos, MD Sponsor: Amgen Corporation Cervical Dystonia If you have cervical dystonia and would like more information regarding participation in a clinical trial that involves treatment for this disease, please contact Katie Arrigo at (773) 834-1688 or karrigo@neurology.bsd.uchicago.edu Epilepsy Trials Sabril for Epilepsy Study ongoing. Enrollment closed. Principal investigator: Jean-Paul Spire, MD Nurse coordinator: Patricia Manning, RN (773) 702-9812 Sponsor: Marrion Merrill Dow Movement Disorders/Parkinson's Trials For more information on research studies involving Parkinson's Disease, Huntington's Disease, or other movement disorders, please contact Katie Arrigo at (773) 834-1688 or via e-mail. For general information on our program, please see the University of Chicago Center for Parkinson's Disease and Movement Disorders web site. Liatermin (r-metHuGDNF) Enrollment closed. This medication will be administered by bilaterial intraputaminal (IPU) infution to subjects with idiopathic Parkinson's Disease. Principal investigator: Arif Dalvi, MD Coordinator: Joan Young (773) 702-4392 Genetic Study for Siblings with Parkinson's Disease Enrollment closed. Principal investigator: Un Jung Kang, MD Coordinator: Barbara Clay (773) 834-1688 MAO-B Inhibitor for Early Parkinson's Disease Enrollment closed. Study was for patients with newly diagnosed Parkinson's disease who are not on Sinemet. Principal investigator: Un Jung Kang, MD Coordinator: Barbara Clay (773) 834-1688 Neuroprotection for Early Parkinson's Disease Enrollment closed. Study was for patients with newly diagnosed Parkinson's disease who are not on symptomatic therapy. Principal investigator: Un Jung Kang, MD Coordinator: Barbara Clay (773) 834-1688 Transdermal Dopamine Agonist for Early Parkinson's Disease Enrollment closed. Principal investigator: Un Jung Kang, MD Coordinator: Barbara Clay (773) 834-1688 Multiple Sclerosis (MS) - Ongoing Trials Enrollment Open Volunteers for trials are welcome. Please contact Mildred Valentine (773-702-9812). FTY720 in Relapsing/Remitting MS (Oral Treatment) New experimental drug taken orally for relapsing/remitting MS. This two year research study will determine if a new experimental drug taken by mouth once daily can reduce the number of relapses in patients with relapsing/remitting MS. It will also evaluate how safe and well tolerated the experimental drug is when used for up to two years. Selection Criteria: - 18 to 55 years old - Relapsing/Remitting MS - EDSS score: 0 to 5.5 (able to walk 100 meters without aids) - Must be available for clinic visits for the duration of the study Principal investigator: Anthony Reder, MD Study coordinator: Mildred Valentine - 773-702-9812 Single vs. Double-dose Copaxone for Relapsing/Remitting MS This two year study will determine if an experimental dose of Copaxone is safe, tolerable, and more effective than the currently approved dose. Selection Criteria: - 18 to 55 years old - Relapsing/Remitting MS - EDSS (expanded disability status score) 0 to 5.0 (able to walk 200 meters without assistance) - Never on any therapy for MS (other than steriods more than 3 months ago Principal Investigator: Adil Javed, MD Project coordinator: Krystal Ivy (773) 834-4652 Ongoing Trials for Multiple Sclerosis (MS) - Enrollment Closed Anti-B Cell Antibody (Rituxan) for Progressive MS The purpose of this study is to investigate an Anti-B cell antibody in the treatment of Primary Progressive MS. Selection Criteria: - 2 1/2 year study - 18 to 65 years old - Not on any therapy for MS three months before screening - Primary Progressive MS - EDSS (Expanded Disability Status Scale) 2.0 to 6.5 - Constant bilateral support (cane, crutches, braces) required to walk 20m without resting, or better. Principal investigator: Anthony Reder, MD Sub-investigators: Barry G.W. Arnason, MD, Avertano Noronha, MD and Adil Javed, MD Study coordinator: Mildred Valentine - 773-702-9812 BEYOND Study for Relapsing/Remitting MS Enrollment closed. Study on-going. The purpose of this two year study is to determine: 1. If an experimental dose of a currently approved drug is safe, tolerable, and more effective than the currently approved dose. 2. Which of two commonly used drugs is safer, more tolerable, and more effective in treating this disease. Selection criteria: - 18 to 55 years old - No treatment for MS within past 3 months - Relapsing/remitting MS (symptoms flare up and then become more stable) - EDSS (expanded disability status scale) 0 to 5.0 (able to walk 200 meters without assistance Principal investigator: Barry G.W. Arnason, MD Sub-investigators: Anthony Reder, MD; Avertano Noronha, MD; Roumen Balabanov, MD; Agnes Kim, MD; Darshan Shah, MD; Adil Javed, MD. Study coordinator: Mildred Valentine (773) 702-9812 Novantrone in MS Enrollment closed. Study on-going. This is a phase IV monitoring study of the effects of Mitoxantrone/Novantrone in active MS. This drug was recently approved by the FDA, and is a form of chemotherapy that reduces the white blood cells that attack the brain. WBC, liver function, and cardiac function will be monitored. Selection criteria include: Age 18-65. Exclusion: primary progressive MS, heart disease. Principal investigator: Anthony Reder, MD Rebif vs Copaxone in Relapsing/Remitting MS Enrollment closed. Data being analyzed. The purpose of this study is to compare the safety and effectiveness of two FDA approved drugs for the treatment of relapsing/remitting MS. Selection criteria: - 18 to 60 years old - Not on any therapy for MS - Repapsing/remitting MS (symptoms flare up and then get somewhat better) -EDSS (expanded disability status scale) 0 to 5.0 (able to walk 200 meters without assistance) Principal investigator: Anthony Reder, MD Sub-investigators: Barry G.W. Arnason, MD and Avertano Noronha, MD Study coordinator: Mildred Valentine - 773-702-9812 MS - Completed Studies for Historical Reference Antegren Phase II Completed in 2001. Showed that 6 monthly infusions of the antibody to the VLA-4 adhesion molecule were safe and reduced attacks by 50% and enhancing lesions on MRI by 80%-90%. Antiproliferative Therapy of MS (Paclitaxel) Cancelled because Phase II trial showed no effect. Aricept Trial in MS Study terminated. This study compared placebo with Aricept to see if memory and cognitive function improved over 12 weeks. In a related study, this drug improved memory and thinking speed in MS. Selection criteria include: 25 - 60 years old Able to walk a few steps with support Moderate memory/cognitive problems On no drugs that could interfere with mental function Principal investigator: Anthony Reder, MD Nurse coordinators: Patricia Manning, RN and Bernadine Lake ATM-027 Antibody to T Cell Receptor Study was closed by sponsor before patient enrollment. Avonex (IFN beta-1a) for First Attack of MS-like Illness (optic neuritis, transverse myelitis, etc.) Results: Reduced the number of patients who developed MS. Principal investigator: Anthony Reder, MD Sub-investigator: Avertano Noronha, MD Sponsor: Biogen. Betaseron (IFN beta-1b) for secondary-Progressive MS Study ended in 2000. Results: IFN reduced attacks and MRI lesions, yet had minimal effect on patients who had progression without concurrent attacks. Principal investigator: Barry G.W. Arnason, MD Sub-investigators: Avertano Noronha, MD; Anthony Reder, MD Nurse coordinator: Patricia Manning, RN MSN Sponsor: Berlex Laboratories Copaxone (Cop1; Glatiramer acetate) in primary progressive MS Study terminated. Finding: Subcutaneous injections of Copaxone are not effective in slowing the progression of primary progressive multiple sclerosis. The study lasted two and one half years. Analysis is in progress to see if a subgroup of patients responded. Selection criteria include: Primary progressive MS No history of prior attacks of neurological disease (no relapses or exacerbation) 30 - 65 years old Kurtzke score in the range of 3.0 - 6.5 (walk 20 yards with support) Principal investigator: Anthony Reder, MD Sub-investigator: Barry G.W. Arnason, MD; Avertano Noronha, MD Research nurse: Patricia Manning, RN, MSN (773) 702-9812 Study cordinators: Lily Wong, MA (773-834-4654) and Barbara Harding-Clay (773-702-9812) Cyclosporin for MS Study terminated by sponsor due to renal toxicity, 1986. Results: Some slowing of MS progression Principal investigator: Barry G.W. Arnason Sub-investigator: Anthony Reder, MD and Mark Aguis, MD Sponsor: Sandoz Cytotek (Misoprostol) for MS Study finished, 1997. Drug is approved for other indications and is available for use in MS. Results: Cytotek reduces pain from trigeminal neuralgia (tic douloureux) in MS in patients who have failed all other drug therapies. Principal investigator: Anthony Reder, MD Resident: Debra Babcock, MD Sponsor: G.D. Searle Double-Dose IFN-beta 1b (Phase II) Enrollment closed. Completed 2005. This two year study determined that a very high dose of interferon reduced MRI lesions in relapsing/remitting MS by 40% compared to the FDA approved dose of Betaseron. Selection criteria: 18 - 55 years old Not on therapy for MS Relapsing/remitting MS Principal investigator: Barry G.W. Arnason, MD Sub-investigators: Anthony Reder, MD; Avertano Noronha, MD, and Adil Javed, MD Hu23F2G for Acute Exacerbation of MS Study ended in 1999. Enrollment closed. Monoclonal antibody against the LFA-1 adhesion molecule - to stop homing of lymphocytes to the brain. Results: No effect on MS. Principal investigator: Anthony Reder, MD Sub-investigator: Avertano Noronha, MD Nurse Coordinator: Patricia Manning, RN Sponsor: ICOS Interferon Beta-1b (Betaseron) for Relapsing/Remitting MS Study finished, 1993. Betaseron approved by FDA, 1993 Results: Betaseron reduced relapses and active MRI lesions, and improved visual memory. Principal investigator: Barry G.W. Arnason, MD Sub-investigator: Avertano Noronha, MD, and Anthony Reder, MD Sponsor: Berlex Laboratories Linomide for Secondary Progressive MS Study terminated in 1997 due to side effects. Results: Linomide reduced clinical and MRI activity in MS, but caused heart attacks. Principal investigator: Anthony Reder, MD Sub-investigator: Barry G.W. Arnason, MD; Avertano Noronha, MD Sponsor: Pharmacia Natalizumab (Tysabri) Antibody to Adhesion Molecules VLA-4 (See results of Phase II trial above.) This 2 1/2 year study looked at a new method for blocking the VLA-4 adhesion molecule that allows white blood cells to stick to blood vessels in the brain. Monthly infusions of the monoclonal antibody reduced relapses by 66% and slowed progressions. Selection criteria include: Relapsing/remitting MS One exacerbation in the last 12 months 18 - 50 years old Kurtze score in the range of 0 - 5.0 (able to walk 200 meters without support) No IFNs or Copaxone for at least six months Principal investigator: Anthony Reder, MD Sub-investigator: Barry G.W. Arnason, MD; Avertano Noronha, MD, Adil Javed, MD Coordinator: Mildred Valentine Oral Copaxone The study evaluated the efficacy of oral Copaxone in reducing relapse rates and new MRI lesions. Findings: No significant effect, just as with oral myelin. A high dose repeat trial is under consideration. Principal investigator: Anthony Reder, MD Sub-investigator: Barry G.W. Arnason, MD; Avertano Noronha, MD Research nurse: Patricia Manning, RN, MSN Study coordinator: Lily Wong, MA PPAR-gamma agonists in Remitting/Relapsing MS (Avandia) Enrollment closed. Completed 2004. This one year showed no effect of an oral diabetes pill on reducing MRI lesions, MS attacks, and MS progression. Selection criteria: 18 - 55 years old Not on therapy for MS Relapsing/remitting MS Principal investigator: Anthony Reder, MD Sub-investigators: Barry G.W. Arnason, MD; Avertano Noronha, MD Study coordinator: Mildred Valentine - 773-702-9812 Prevention of Red Spots on Skin with Betaseron Analysis ongoing. Enrollment is closed. Completed 2002. Trial looked at prevention of erythma (red spots) with steriod cream at site of Betaseron injection. Prinicipal investigator: Barry G.W. Arnason, MD Nurse coordinator: Patricia Manning, RN, MSN Rebif vs Avonex Trial Study ongoing. Enrollment is closed. This study compared the therapeutic effect of two IFN beta-1 therapies for relapsing-remitting multiple sclerosis. Participants will receive monthly MRI exams. Finding: Rebif reduced the attack rate and MRI lesions faster than Avonex. Selection criteria include: Relapsing/remitting or Secondary progresssive MS Two exacerbations in the last two years 18 - 55 years old Kurtzke score in the range of 0 - 5.5 (walk 100 meters without aid) No prior IFNs Principal investigator: Anthony Reder, MD Sub-investigator: Barry G.W. Arnason, MD; Avertano Noronha, MD Research nurse: Patricia Manning, RN, MSN (773-702-9812) Rebiject Trial in MS Study ended. Enrollment closed. Completed 2004. Rebiject was effective. Principal investigator: Anthony Reder, MD Nurse coordinator: Patricia Manning, RN (773) 702-9812 T Cell Receptor Vaccine for MS A phase II study of a peptice vaccine to inhibit brain-reactive cells. Principal investigator: Anthony Reder, MD Sponsor: Connective Therapeutics. Contact sponsor for results of this trial. Tegison (Vitamin A) for MS Study ended. Enrollment closed. Data being analyzed. Principal investigator: Barry G.W. Arnason, MD Nurse coordinator: Patricia Manning, RN, MSN Sponsor: Berlex Laboratories Terbutaline in Chronic Progressive MS Study completed, 1995. Drug is available. Results: Terbutaline may reduce fatigue in MS and correct immune abnormalities. Principal investigator: Eva Chelmicka-Schorr, MD Sub-investigator: Barry G.W. Arnason, MD and Anthony Reder, MD Sponsor: The University of Chicago Tizanidine for Spasticity in MS Study finished, 1995. Drug approved by FDA, 1997 Principal investigator: Anthony Reder, MD Sub-investigator: Barry G.W. Arnason, MD Sponsor: Athena Neurosciences. Contact Athena Neurosciences for drug information. TNFR-IgG (Lenercept; RO45-2081) for Relapsing/Remitting MS Study terminated, 1997. Drug appeared to worsen MS. Principal investigator: Barry G.W. Arnason, MD Sub-investigator: Avertano Noronha, MD Sponsor: Hoffman LaRoche Zanaflex for Spasticity in MS and Spinal Cord Damage Study ongoing. Enrollment is closed. Trial will look at the effects of Zanaflex on spasticity and blood pressure. Principal investigator: Anthony Reder, MD Nurse Coordinator: Patricia Manning, RN Myasthenia Gravis Treated with Terbutaline We are enrolling patients to participate in the study of terbutaline as a treatment for myasthenia gravis. This drug is give by mouth and is used to treat patients with asthma. The following are initial selection criteria for participants: 15 to 70 years old. Generalized myasthenia gravis. Prior negative chest CT or thymectomy to elimnate the possibility of thymona. No history of lung disorder, heart disease, EKG abnormalities, orthostatic hypotension, liver disease, kidney disease, hyperthyroidism, infection, cancer, other chronic disabling disorders, or emotional instability. Pregnant patients will not be enrolled. You must be willing to discontinue Mestinon for at least 8 hours prior to clinical testing. There will be a total of 4 visits over a 6 week period, including the intitial screening visit. Please note that not all patients initially evaluated will qualify for the study. If you are interested, please contact Dr. Betty Soliven at (773) 702-6393 Myotonic Dystrophy and Heart Rhythm Disorders We are currently recruiting patients with myotonic dystrophy for a multi-center study sponsored by the Muscular Dystrophy Association. The purpose of the study is to examine the relationship between myotonic dystrophy and heart arrhythmias, in particular, when the arrhythmias develop and how many patient develop these heart problems. Participants will receive yearly Holter monitoring to examine their heart rhythms and free DNA testing for the myotonic dystrophy gene. This study is important because heart arrhythmias are a leading cause of death in persons with myotonic dystrophy. For more information, please call 773-702-1657. Stroke Trials HeADDFIRST: Hemicraniectomy and Durotomy upon Deterioration for Massive Hemispheric Infarction Related Swelling Trial Study closed. Data being analyzed. This purpose of this study is to evaluate the benefits of surgical decompression to decrease the morbidity and mortality from large hemispheric stroke associated brain swelling. Selection criteria include: 18-75 years of age Acute MCA stoke Must develop brain swelling of a specific magnitude The University of Chicago Hospital will facilitate safe, rapid transport and provide feedback to the referring physician/facility. Principal Investigator: Jeffrey I. Frank, MD Nurse Coordinator: Christi Kordeck, RN (773) 834-4604 ARCHeR Balloon angioplasty and stent placement for carotid stenosis in high risk patients. Study is ongoing. Enrollment is open. Principal Investigator: Ted Feldman, MD, section of cardiology Participating Neurologists: James R. Brorson, MD, and Axel Rosengart, MD Nurse Coordinator: Cynthia Kienlen, RN (773) 702-1371 RESPECT Trial Closure of symptomatic patent foramen ovale (PFO) with the Amplatzer PFO occluder device Study is ongoing. Enrollment is open. Principal Investigator: Ziyad Hijasi, section of pediatric cardiology. Participating Neurologists: James Brorson, MD and Axel Rosengart, MD, PhD Nurse coordinators: Mary Heitschmidt, RN, MS, (773) 702-6172 and Christi Kordeck, RN, (773) 834-4604 African-American Stroke Prevention Study The purpose of this study is to compare the effectiveness, in the African-American population, of two different medications that are used to prevent secondary strokes. African-Americans, as a group, suffer from increased rates of strokes. This trial compares two anti-platelet agents, aspirin and ticlipidine. Both of these medications have been proven to lower the risk of stroke, but their effectiveness has not been directly compared in African-Americans. We are looking to enroll volunteers within 90 days of their initial stroke. Persons with most types of stroke are eligible. If you are interested in participating, or would like additional information, please contact Christi Kordeck, RN at (773) 834-4604. Ticlopidine for Stroke Study clossed. Enrollment is closed at this site. Principal investigator: James Brorson, MD Sub-investigator: Richard Kraig, MD Coordinator: Christi Kordeck, RN Phone: (773) 834-4604 RReact (Rapid Response with an Astrocyte modulator in acute Cortical Stroke) A new inverstigational therapy for stroke is being tested by our stroke team and at more than 100 hospitals in the United States and Canada. The purpose of the study is to evaluate the safety and effectiveness of an experimental drug that may reduce brain damage caused by a certain type of stroke (a stroke due to a bloot clot, not for hemorrhagic stroke or bleeding in the brain.) Study is on-going. Enrollment begins March 15, 2003. Selection criteria include: 18-90 years of age acute ischemic stroke must present to the ER or hospital within 6 hours after the initial onset of stroke symptoms. The University of Chicago Hospitals will facilitate safe, rapid transport and provide feedback to the referring physician and facility. Principal Investigator: Jeffrey I. Frank, MD Co-Investigator: Axel Rosengart, MD, PhD Nurse Coordinator: Christi Kordeck, RN Phone: (773) 834-4604