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Clinical Drug Trials

PNR&D investigators are currently involved in clinical trials that proceed from basic research initiatives.

Advanced research in ALS Treatment

PNR&D investigators are committed to the speedy development of new treatments for amyotrophic lateral sclerosis (ALS), as the current methods of therapy are only marginally successful. One type of treatment, using insulin-like growth factor I (IGF-I), has shown promise in a clinical trial for ALS. IGF-I slows motor neuron death and may slow progressive muscle weakness. By enrolling 300 patients for up to 24 months, we are testing the idea that IGF-I maybe a useful therapy in ALS. If the research proves IGF-I is effective, we may have a new therapy for ALS. Preliminary results will be available in December.

This project has three primary goals:

  1. Determine whether IGF-I slows the rate at which ALS patients loose muscle strength.
  2. Determine if IGF-I delays the need for a tracheostomy to help ALS patients breathe.
  3. Determine if IGF-I affects the ability of ALS patients to perform daily tasks.

This study, if positive, will provide rationale for the clinical use of IGF-I in patients with ALS and will support approval of this medication by the FDA. This clinical trial is funded by the National Institutes of Health grant RO1 NS42759 entitled "A Trial of Insulin-Like Growth Factor-I (IGF-I) in the treatment of patients with ALS."

Preliminary results will be available in December.

Diabetic Neuropathy

In addition to directing the PNR&D, 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 PNR&D 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.

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