The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
194
Tablets for oral administration.
Capsules for oral administration.
Placebo matched to SUZ for oral administration.
Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
Time frame: Baseline, At Week 12
Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score
Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) score, which asks participants to describe how pain interfered with the participant's sleep. Response options for the DSIS range from 0 (none) to 10 (severe).
Time frame: Baseline, At Week 12
Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with ≥30% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Time frame: Baseline, At Week 12
Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.The percentage of participants with ≥50% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Time frame: Baseline, At Week 12
Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with ≥70% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
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Placebo matched to pregabalin for oral administration.
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Synexus Clinical Research US - Birmingham
Birmingham, Alabama, United States
Synexus Clinical Research US - Phoenix West
Phoenix, Arizona, United States
Velocity Clinical Research - Banning
Banning, California, United States
Long Beach Clinical Trials Services, Inc.
Long Beach, California, United States
University Clinical Investigators
Tustin, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
AMR Fort Myers (The Clinical Study Center)
Fort Myers, Florida, United States
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, United States
...and 40 more locations
Time frame: Baseline, At Week 12
Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment
PGIC is an instrument that measures change in participants' overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Baseline, At Week 12
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Week 14