NCT02878798

Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)

Topiramate as a Disease Modifying Therapy for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	topiramate	Oral topiramate at a target dose of 50mg twice daily.
OTHER	Placebo	overencapsulated placebo of identical color, shape and packaging to topiramate

Timeline

• Start date: 2018-02-12
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2016-08-25
• Last updated: 2023-11-14
• Results posted: 2023-11-14

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study