NCT01561027

Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

A Randomized, Double Blind, Cross-over Study to Evaluate the Safety and Efficacy of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.

Detailed description

The study consists of two treatment periods of 22 days with randomized CNV1014802 350mg or placebo administered twice daily. In addition, single blind placebo will be administered during a two week run-in, a two week wash-out period between the two treatment periods, and a one week run-out phase. This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Conditions

• Lumbosacral Radiculopathy

Interventions

Type	Name	Description
DRUG	CNV1014802	Administered as specified in treatment arm.
DRUG	Placebo	Administered as specified in treatment arm

Timeline

• Start date: 2011-04-30
• Primary completion: 2012-06-30
• Completion: 2012-08-31
• First posted: 2012-03-22
• Last updated: 2017-10-13

Locations

12 sites across 4 countries: Czechia, Denmark, France, Sweden