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Two double-blind, placebo-controlled therapeutic trials using recombinant human insulin-like growth factor-I (rhIGF-I) were conducted in patients with mild-to-moderate ALS. This presentation will focus on the results of the first trial conducted at eight centers in North America.
IGF-I is a naturally occurring single-chain polypeptide consisting of 70 amino acids. It is expressed by a number of tissues including muscle and CNS structures. Receptors for IGF-I are found throughout the body, including spinal motor neurons, muscle, and brain. Administration of rhIGF-I induces sprouting of peripheral nerves, enhances neuronal regeneration in animal models of axotomy or nerve injury, and enhances survival of spinal cord motor neurons in a variety of experimental systems of motor neuron death. These properties of rhIGF-I provided the rationale for the clinical trials in ALS.
Hypothesis and background.
This study was designed to assess the effects of rhIGF-I in patients with mild-to-moderate ALS under the hypothesis that rhIGF-I would slow the rate of disease progression and disability compared with patients treated with placebo. The Appel ALS (AALS) rating scale [1] was selected as the primary outcome measure because it is an accurate index of disease severity, is reproducible, easy to administer, and uses traditional methods of assessment that have gained clinical acceptance (e.g., forced vital capacity [FVC], Medical Research Council [MRC] graded manual muscle testing, and timed activities such as walking specific distances). The AALS score is needed because none of the traditional methods accurately reflects the total activity of the disease because of the variable degree of affection of bulbar function, breathing, and limb strength or function.
The AALS score is the sum of five component scores as follows: bulbar function, respiratory function, muscle strength, and muscle function of arm and leg. The five component scores are summed to obtain an AALS score. An AALS score for a patient without …
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