At a glance
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Topiramate as a Disease Modifying Therapy for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
In Brief
A Phase 2 clinical trial evaluating topiramate and Placebo for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome. Completed, enrolled 132 participants across 20 sites.
Detailed Summary
The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate as a potential disease modifying therapy for cryptogenic sensory peripheral neuropathy (CSPN). Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do not have an alternative cause for neuropathy will be potentially eligible. The co primary outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN) Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase will last 24 months.
Study Details
Timeline
Interventions
Oral topiramate at a target dose of 50mg twice daily.
overencapsulated placebo of identical color, shape and packaging to topiramate