NCT04148573

Clinical Trial to Evaluate Safety, Tolerability and Efficacy of NFX88 in SCI

Randomized, Double-blind, Placebo Controlled, Parallel, Multicentric, Phase IIa Clinical Trial to Evaluate Safety, Tolerability, Therapeutic Efficacy of Daily Oral Treatment NFX88 on Neuropathic Pain in Patients With Spinal Cord Injury

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Neurofix S.L. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In summary, this small-scale study is designed to demonstrate that the NFX88 is safe and well tolerated, as well as preliminary evidence of improvement in the score of VAS, PD-Q, and PGIC scales.

Detailed description

This is a Phase IIa (proof of concept), randomized, double-blind, placebo controlled, parallel group, multicentric, clinical trial to evaluate the safety, tolerability and efficacy of daily oral treatment with NFX88 in SCI patients who are not receiving opiates or cannabinoids and present neuropathic pain with an average pain score ≥ 4 measured with a VAS scale during the last week at screening

Conditions

• Neuropathic Pain
• Spinal Cord Injuries

Interventions

Type	Name	Description
DRUG	NFX88 - 1	3 times a day
DRUG	NFX88 - 2	3 times a day
DRUG	NFX88 - 3	3 times a day
DRUG	PLACEBO - 4	3 times a day

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-05-20
• Completion: 2022-07-20
• First posted: 2019-11-01
• Last updated: 2022-12-02

Locations

7 sites across 1 country: Spain