Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
- Registration Number
- NCT04147858
- Lead Sponsor
- Aptinyx
- Brief Summary
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
- Detailed Description
This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with fibromyalgia.
This 13- to 16-week study will include a 1- to 4-week Screening Period followed by a 12-week double-blind, randomized, placebo-controlled Treatment Period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
Not provided
- Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
- Current or historical serious medical conditions
- Prior participation in NYX-2925 clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NYX-2925 50 mg NYX-2925 NYX-2925 50 mg administered orally. NYX-2925 100 mg NYX-2925 NYX-2925 100 mg administered orally. Placebo Placebo Placebo administered orally.
- Primary Outcome Measures
Name Time Method Change in the Mean Numerical Rating Scale (NRS) Score Week 12 Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)
- Secondary Outcome Measures
Name Time Method Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score Week 12 Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score, scores range from 0-40, with higher scores indicating greater sleep disturbance.
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score Week 12 Change from baseline to Week 12 in the PROMIS-FM fatigue profile score, scores range from 0-80, with higher scores indicating greater impact of fatigue
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score Week 12 Change from baseline to Week 12 in the PROMIS-FM physical function score, scores range from 0-60, with higher scores indicating greater difficulty with physical function.
Use of Rescue Medication Week 12 The number of subjects using rescue medication.
Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12 Week 12 Number of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12
Number of Subjects Achieving ≥30% Pain Reduction Week 12 Number of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS Scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain).
Fibromyalgia Impact Questionnaire-Revised (FIQR) Score Week 12 Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score; FIQR scores range from 0-100, with higher scores indicating greater impact of fibromyalgia
Daily Sleep Interference (DSIS) Score Week 12 Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12; Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep, unable to sleep due to pain), with higher scores indicating greater interference with sleep.
Number of Subjects Achieving ≥50% Pain Reduction Week 12 Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)
Trial Locations
- Locations (1)
Aptinyx Clinical Site
🇺🇸Bellevue, Washington, United States