NCT03722680

Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.

Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a phase II trial, randomized, parallel, double blind, multicenter, comparing riluzole versus placebo. The trial population is composed of patients ≥18 years old that have developed stage II/III colorectal cancer and are eligible for Simplified FOLFOX4 (6-12 cycles) adjuvant chemotherapy. The primary objective is to assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy during the Simplified FOLFOX4 adjuvant chemotherapy of stage II/III colorectal cancers.

Conditions

• Oxaliplatin-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Riluzole	Riluzole during chemotherapy (oxaliplatin)
DRUG	Placebo Oral Tablet	placebo

Timeline

• Start date: 2020-10-28
• Primary completion: 2024-08-01
• Completion: 2025-12-31
• First posted: 2018-10-29
• Last updated: 2025-04-23

Locations

16 sites across 1 country: France