A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy of VX-150 for the treatment of pain caused by small fiber neuropathy.

Timeline

Start

2017-09-20

Primary completion

2018-10-12

Completion

2018-11-08

Outcome

Met primary endpoint

registry analysis (superiority test); VX-150 vs Placebo; p <0.0001; Least Squares (LS) Mean Difference -1.085 (95% CI -1.876 to -0.293) NCT03304522 ↗

release “The study met its primary endpoint and showed that treatment with VX-150 demonstrated statistically significant and clinically meaningful pain reduction” vrtx.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VX-150	Unknown	1250 mg	Oral

Indications