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In this issue of Neurology, et al.1 present the results of a Phase II randomized clinical trial of recombinant human nerve growth factor (rhNGF) in human diabetic polyneuropathy. In the trial, patients were randomized to placebo, a lower dose of rhNGF, or a higher dose of rhNGF administered subcutaneously thrice weekly over 6 months. Efficacy was judged on the basis of symptom profiles (neuropathy symptom profile[NSP], neuropathy symptoms and change [NSC], and global symptom assessment), neurologic examination (lower limb neuropathy impairment scale [NIS-LL]), conventional nerve conduction recordings, and quantitative sensory testing of the cooling detection threshold (CDT), heat as pain (HP:5.0), and vibration detection threshold (VDT). There was an improvement in CDT, a borderline improvement in HP, and encouraging trends toward improvement in the examination findings. Prospectively identified indices of small fiber sensory function in combination confirmed the selected benefits of rhNGF. Globally the patients felt better, but specific symptom profiles did not improve.
The study has several important features to commend it. It is the first published randomized trial of a neurotrophin in human diabetic polyneuropathy and as such may herald a new type of treatment approach to this hitherto largely untreatable disorder. The approach to the agent was rational and thoughtful in that fiber classes expected to be affected by rhNGF were specifically tested using quantitative techniques. Similarly, both …
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