Talampanel for the Treatment of ALS
Teva Pharmaceuticals, LTD is conducting a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability, and safety of oral administration of investigational product Talampanel compared to placebo in subjects with ALS (ALSTAR).
At present, ALS remains a disease for which limited effective treatment options are available. Currently, riluzole is the only approved drug for the treatment of this disease. The benefits of riluzole, although consistent, are modest. Riluzole prolongs survival in ALS patients for several months, but has not been shown to have significant effect on measures of function.
Talampanel is a selective AMPA receptor antagonist that prevents glutamate excitotoxicity, a trigger for motor neuron death. AMPA antagonists have shown clear beneficial effect in mouse models of ALS, including prolonged survival, and maintained and improved motor function. In addition to these studies, Talampanel has been studied in a small group of human subjects with ALS, showing a more positive trend in the ALS Functional Rating Scale as compared to those treated with placebo.
The purpose of this study is to assess the efficacy, tolerability and safety of Talampanel in a larger patient population, specifically monitoring the rate of change in the ALS Functional Rating Scale throughout the duration of the trial. Subjects being treated with riluzole may continue this treatment and still participate in the Talampanel study.
You can read more information regarding the study at:
http://www.clinicaltrials.gov -
Enrollment Status: Closed
Principal Investigator:
Jeremy M. Shefner, MD, PhD, SUNY Upstate Medical University
Participating centers and contact information:
SUNY Upstate Medical University
Mary Lou Watson: 315-464-5004
University of Kansas Medical Center
Maureen Walsh: 913-588-0609
Massachusetts General Hospital
Darlene Pulley: 617-726-6190
CA Medical Center
Marguerite Engel: 415-600-3758
Columbia University
Daniel Bell: 212-305-8148
John Hopkins University
Richard Kimball: 410- 955-8511
Mayo Clinic - Rochester
Sherry Klingerman: 507-284-0451
updated 08/03/09
