NCT00876538

Effect of TRO19622 in the Treatment of Patients With Chemotherapy Induced Peripheral Neuropathy

A Double Blind, Placebo Controlled Study of the Effect of 330 mg QD of TRO19622 in the Treatment of Chemotherapy Induced Peripheral Neuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores.

Detailed description

Chemotherapy Induced Peripheral Neuropathy represents a frequent and invalidating side effect that requires treatment. Current treatment options are multiple, but none have yet demonstrated efficacy in double-blind clinical trials . This study will provide information useful to determine the potential of TRO19622 to relieve both pain and dysesthesia which are the most common symptoms experienced by patients with peripheral neuropathy following taxane chemotherapy. At the start of the study, patients will be randomized to one of two groups : TRO19622 (330 mg QD or placebo once a day). Each treatment will be administered for 6 weeks. Additionally, patients will have the option to continue treatment for another 6 weeks duration. Treatment will be administered under double-blind conditions. The product under evaluation will be administered to patients receiving the standard of care for CIPN.

Conditions

• Chemotherapy-Induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Olesoxime (TRO19622)	2 capsules of TRO19622 (330 mg) once day with the noon meal
DRUG	Placebo Control	Placebo Control 2 capsules once day with the noon meal

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-04-06
• Last updated: 2016-11-22

Locations

8 sites across 1 country: France