Principal Investigator: Gordon Smith
Keywords: Neuropathy , Cryptogenic Sensory Polyneuropathy , Pain , foot numbness , foot pain Department: Neurology
IRB Number: 00077396
Specialty: Neurology
Sub Specialties: Neuropathy
Recruitment Status: Recruiting

Contact Information

Cathy Revere

Brief Summary

Peripheral Neuropathy affects over 20 million Americans. Some neuropathies are secondary to readily identifiable causes, with diabetic sensory polyneuropathy being the most common cause in the United States. Once known causes are excluded, approximately 25 to 50% remain idiopathic and are referred to as cryptogenic sensory polyneuropathy (CSPN). This usually affects people over the age of 50. Neuropathic pain is a presenting symptom in 70-80% of CSPN.  According to a poll obtained by the Neuropathy Association, 87% of patients rated pain management as the most challenging in managing their neuropathy.  Currently there have been no prospective trials performed in the large CSPN group. 
The overall objective of this trial is to determine which pharmaceutical therapy is most effective and causes the fewest side effects in CSPN. To do this comparative effectiveness study, we will use an adaptive design model.
Specific Aim 1: Determine which drug is most effective in producing pain relief and improving quality of life in patients with CSPN. We will perform a prospective randomized comparative effectiveness adaptive design study in neuropathy patients with pain who do not have diabetes and for whom no other cause has been found. The four drugs we will use are nortriptyline, duloxetine, pregabalin and mexiletine. 
Specific Aim 2: Determine which drug has the fewest and which has the most side effects. We will use the MedDRA adverse event coding system and the number of dropouts due to side effects.

Inclusion Criteria

- Age 30 or older

- Diagnosis of cryptogenic sensory polyneuropathy

- Likert Pain Score of greater than or equal to 4

- Must not be currently on nortriptyline, duloxetine, pregabalin, mexiletine, or similar class of medication for at least 7 days from baseline study visit 


Exclusion Criteria

- Any medical condition or current medication (see attached exclusionary drug list) that would prevent participant from taking either nortiptyline, duloxetine, pregabalin, or mexiletine

- Unable to give consent

- Unable or not willing to comply with the study

- Other causes for polyneuropathy