Determining Best or Inferior Drug(s) Using an Adaptive Platform for Cryptogenic Sensory Polyneuropathy

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Significance: Chronic pain and the opioid epidemic continue to dominate public health concerns in the US.[1][2][3] The World Health Organization has estimated that 22% of the world's primary care patients have chronic pain making this condition a problem to be addressed by all physicians and health professionals.4 Peripheral neuropathy is a common, chronic pain problem encountered by neurologists and primary care physicians, and while there are many causes, no cause can be identified for a large percentage of patients.5 Many peripheral neuropathies are secondary to identifiable causes, such as diabetes, alcohol abuse and the use of certain medications.However, once known etiologies are excluded, at least 25% of neuropathies remain idiopathic.This is the case for 5 million people (of the estimated 20 million people with neuropathy) in the United States.We refer to these remaining cases as Cryptogenic Sensory Polyneuropathy (CSPN, commonly pronounced as C SPAN).[6][7][8][9][10][11][12][13][14][15][16] The research question is: What is the best available medication(s) to treat pain due to CSPN?There is only one comparative effectiveness study of medications most used to treat painful CSPN, conducted by the investigators involved in this application.17 This larger, open-label, pragmatic trial will paint a more complete picture of medication effectiveness, testing six new non-opiate medications and creatively blending the results from the prior four drug trial in an elegant statistical analysis.This study adds critical components that address barriers to diagnosis and barriers to implementation of study results in clinical practice.Description and diagnosis: Prior reports describing CSPN have used other terms such as idiopathic neuropathy or small fiber sensory peripheral neuropathy, but we prefer CSPN.The assigned ICD-10 code is G60.8.The diagnostic criteria for CSPN were established by Dr. Barohn and colleagues.13 Our retrospective review of databases from two North and one South American tertiary neuropathy clinics (NA-SA study) showed that CSPN represented at least one-quarter of all referred peripheral neuropathy patients and was the most common form of neuropathy evaluated at these sites (Table 1).18 The mean age of patients in prior publications ranges from 51 to 63 years.8,9,13,18 CSPN is usually diagnosed based on pain (a presenting symptom in 70-80% of patients), numbness and/or tingling in the distal extremities.There are equal numbers of men and women with this condition, and it occurs in all races/ethnicities and all geographic regions.The most common symptoms are pain (as noted above), sensory loss (86%), and paresthesia (86% to 100%).[6][7][8][9][10][13][14][15][16][18][19][20][21][22] Lower extremity symptoms usually precede upper extremity symptoms.13,14,18 Approximately one-third to one-half of patients will have symptoms confined to their lower extremities.The average time for symptoms to spread to the upper extremities appears to be about five years.Worsening of sensory symptoms with contact, heat exposure, activity, or fatigue commonly is reported.Based on symptom presentation, our group and others have found that patients with CSPN constitute a homogeneous group of elderly women and men for whom a similar approach can be taken regarding diagnosis and treatment.13,14,18 Table 2. First-, second-and third-line therapeutic options for CSPN (blue shaded medications were included in PAIN CONTRoLS study); bold/CAP &yellow shaded medications included for this study) PRESCRIPTION THERAPIES Route Starting Dose Maintenance Dose Positive RCT FDA approval for pain First Line: Tricyclic Anti-Depressants Oral 10-25 mg at bedtime Increase by increments of 10-25 mg to 100-150 mg at bedtime Yes Chronic pain GABAPENTIN (Neurontin) Oral 300 mg tid Increase by 300-400 mg increments to 2400-6000 mg daily divided in 3-4 doses Yes Post herpetic neuralgia

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