ALS Clinical Trials

ALS

The Great Lakes ALS Consortium is conducting a clinical trial is to determine whether IGF-I (trade name MyotrophinTM) slows progression of weakness in amyotrophic lateral sclerosis (ALS). Three hundred patients with ALS will participate in a double blind, placebo-controlled two-year study. Half the patients will receive IGF-I and the other half will receive a placebo. The drug will be administered twice a day subcutaneously. The primary endpoint will be the rate of change in manual muscle testing score (MMT). Secondary endpoints will include tracheotomy free survival and change in ALS Functional Rating Score (ALSFRS).

Enrollment began in the summer of 2003. PFUND investigators have enrolled 24 patients as of July 2004. This clinical trial is funded by the National Institute of Health’s National Institute of Neurological Diseases and Stroke (NINDS) and The ALS Association.

For more information on this study, please contact the study coordinator, Timothy Funckes RN tfunckes@umich.edu.

NOTE: CLOSED TO RECRUITMENT. The trial is still ongoing and information is available but no new patients can enroll. Please check back for updates on new studies.

Diabetic Neuropathy

In addition to directing the PFUND, Dr. Eva Feldman also directs the Juvenile Diabetes Research Foundation Center of Excellence for the Study of Complications in Diabetes at the University of Michigan. Through this joint role, a number of PFUND Investigators also work in the Complications Center. The team is currently conducting a clinical trial of a triple antioxidant therapy in type 1 (juvenile onset) diabetic patients. The three drugs are nicotinamide (Endur-Amide TM, Innovite Inc., Tigard, OR), allopurinol (Zyloprim TM, Prometheus Laboratories, San Diego, CA), and alpha-lipoic acid (Thioctacid TM, Asta Medica, Frankfurt, Germany). Patients interested in enrolling in this trial should contact the study coordinator; Cynthia Plunkett, R.N.C. at cplunket@umich.edu or 734-936-8065.

Impaired Glucose Tolerance causing Neuropathy

Doctors at the University of Michigan as well as Utah and New Jersey are conducting a study on Impaired Glucose Tolerance and Neuropathy, (IGTN). This is sometimes known as “Pre-diabetes”. Recently, a study showed that many people with pre-diabetes or (IGTN) have a risk of unknown cause of neuropathy symptoms, increased risk for heart disease, strokes or becoming a diabetic. With a diet and exercise program this study will monitor a persons blood sugar’s for 24 mos. There will be tests of autonomic and peripheral nerves at the beginning, middle and end of the study. The participants will have a nutritionist and study personnel meet with them on a regular basis, every 3mos. to work with them on their diet and excercise. This study does not involve any medication.

For more information, or to see if you are eligible for this research trial you can contact the study coordinator Susan Nalepa, sumsn@umich.edu.

NOTE: CLOSED TO RECRUITMENT. The trial is still ongoing and information is available but no new patients can enroll. Please check back for updates on new studies.