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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
Change in Weekly Average of Daily Pain Intensity on the 11 Point NRS
Pain intensity was evaluated using the 11-point NRS (where 0 signified no pain and 10 signified worst imaginable pain) during the last 24 hours on the NRS each evening. Higher score indicates greater level of pain.
Time frame: From Baseline at Week 6
Percentage of Participants With Greater Than or Equal to (>=) 30 Percent (%) Reduction in the Weekly Average of Daily Pain Intensity on the 11-Point NRS
Pain intensity was evaluated using the 11-point NRS (where 0 signified no pain and 10 signified worst imaginable pain) during the last 24 hours on the NRS each evening. Higher score indicates greater level of pain. Percentage of participants \>= 30% reduction in the weekly average of daily pain intensity on the 11-Point NRS were reported.
Time frame: From Baseline at Week 6
Percentage of Participants With >=50% Reduction in the Weekly Average of Daily Pain Intensity on the 11-Point NRS
Pain intensity was evaluated using the 11-point NRS (where 0 signified no pain and 10 signified worst imaginable pain) during the last 24 hours on the NRS each evening. Higher score indicates greater level of pain. Percentage of participants \>= 50% reduction in the weekly average of daily pain intensity on the 11-Point NRS were reported.
Time frame: From Baseline at Week 6
Change in the Daily Sleep Interference Scale (DSIS)
Pain-associated sleep interference was assessed using DSIS, based on an 11-point scale (where 0 signified none: pain does not interfere with sleep and 10 signified severe: pain completely interferes with sleep, unable to sleep). Higher score indicates greater pain associated sleep interference.
Time frame: From Baseline at Week 6
Percentage of Participants Categorized as Improved on the Patient Global Impression of Change (PGIC) Scale
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Xenoscience Inc. - 21st Century Neurology
Phoenix, Arizona, United States
Phoenix Neurological Associates, Ltd.
Phoenix, Arizona, United States
Sutter Health - Alta Bates Summit Medical Center - The Jordan Research & Education Institute
Berkeley, California, United States
Neuropain Medical Center
Fresno, California, United States
University of California San Diego
La Jolla, California, United States
SDS Clinical Trials, Inc.
Orange, California, United States
Stanford University School of Medicine
Redwood City, California, United States
Blue Sky Neurology
Englewood, Colorado, United States
Bioclinica Research - Orlando
Orlando, Florida, United States
Infinity Clinical Research
Sunrise, Florida, United States
...and 24 more locations
PGIC scale evaluated the change in activity limitations, symptoms, emotions, and overall quality of life (QoL) related to the participants painful condition on 7-point scale from 1 (improved) to 7 (worse). Participants were categorized as following: scale from 1 - 2 were categorized as "improved", scale from 3 - 4 as "no change" and scale from 5 - 7 were categorized as "worse". Percentage of participants categorized as improved on PGIC scale at week 6 were reported for this outcome measure.
Time frame: At Week 6
Change in Pain Intensity on the 11-Point NRS
Pain intensity was evaluated using the 11-point NRS (where 0 signified no pain and 10 signified worst imaginable pain) during the last 24 hours on the NRS each evening. Higher score indicates greater level of pain. Higher score indicates greater level of pain.
Time frame: From Baseline at Week 6
Pre-dose Plasma Concentration (Ctrough) of VRT-1207355 and the Metabolite VRT-1268114
Time frame: Pre-dose at Day 7
Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses
The C-SSRS is an interview-based rating scale was evaluated through a series of questions about suicidal thoughts and behaviors with the possible answers yes or no. Yes represents a worse outcome. Clinically Meaningfulness of C-SSRS responses were judged by investigator based on answers received from participants.
Time frame: Day 1 up to Week 10
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Week 10