To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.
This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with neuropathic pain associated with diabetic peripheral neuropathy. The study will be a 13- to 16-week study, including a 1- to 4-week Screening Period, followed by a 12- week double-blind, randomized, placebo-controlled Treatment Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
228
NYX-2925 administered orally
Placebo administered orally
Pain Intensity Numeric Rating Scale (NRS) Score
Change from baseline in the weekly mean of the daily Numeric Rating Scale (NRS) score assessing average pain intensity related to DPN in the past 24 hours. In the NRS, a participant selects a whole number (0 to 10) that best indicates the intensity of his/her pain, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: Week 12
Daily Sleep Interference Scale (DSIS) Score
Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores. The DSIS asks participants to ''Select the number that best describes how much your pain has interfered with your sleep during the past 24 hours.'' Response options for the DSIS range from 0 (did not interfere with sleep) to 10 (completely interfered with sleep/unable to sleep due to pain).
Time frame: Week 12
Patient Global Impression of Change (PGI-C)
Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)
Time frame: Week 12
Number of Subjects Achieving ≥30% Pain Reduction
Number of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN
Time frame: Week 12
Number of Subjects Achieving ≥50% Reduction
Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN
Time frame: Week 12
Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score
Change from baseline in the Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) score. The QOL-DN is a 47 item subject reported questionnaire. Scores range from 0-126, and lower scores indicate improved quality of life.
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Aptinyx Clinical Site
Fresno, California, United States
Aptinyx Clinical Site
Irvine, California, United States
Aptinyx Clinical Site
Lomita, California, United States
Aptinyx Clinical Site
Los Angeles, California, United States
Aptinyx Clinical Site
Norco, California, United States
Aptinyx Clinical Site
Pomona, California, United States
Aptinyx Clinical Site
Santa Ana, California, United States
Aptinyx Clinical Site
Tustin, California, United States
Aptinyx Clinical Site
Brandon, Florida, United States
Aptinyx Clinical Site
Clearwater, Florida, United States
...and 25 more locations
Time frame: Week 12
Use of Rescue Medication
Number of subjects using rescue medication
Time frame: Week 12