Phase 2
Completed N=310
Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Source: ClinicalTrials.gov NCT04147858 ↗Enrolled (actual)
310
Serious AEs
0.7%
Results posted
Apr 2023
Primary outcomePrimary: Change in the Mean Numerical Rating Scale (NRS) Score — -1.26; -1.47; -1.23 units on a scale — p=0.539
Summary
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Mean Numerical Rating Scale (NRS) Score |
-1.26; -1.47; -1.23 | 0.539 |
| SECONDARY Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12 |
22; 24; 24 | 0.824 |
| SECONDARY Daily Sleep Interference (DSIS) Score |
-1.42; -1.45; -1.38 | 0.297 |
| SECONDARY Number of Subjects Achieving ≥30% Pain Reduction |
30; 34; 29 | 0.871 |
| SECONDARY Number of Subjects Achieving ≥50% Pain Reduction |
13; 15; 13 | 1.000 |
| SECONDARY Fibromyalgia Impact Questionnaire-Revised (FIQR) Score |
-12.6; -12.3; -9.9 | 0.059 |
| SECONDARY Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score |
-3.59; -3.93; -4.66 | 0.888 |
| SECONDARY Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score |
-3.5; -3.7; -2.9 | 0.536 |
| SECONDARY Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score |
2.18; 2.08; 1.83 | 0.190 |
| SECONDARY Use of Rescue Medication |
93; 87; 88 | 0.097 |
Eligibility Criteria
Inclusion criteria
- Informed consent
- Subject has a history of fibromyalgia that was diagnosed >1 year prior to screening and reports at least moderate pain over the last week
- Stable protocol allowed medication and other therapies during the study
- Agrees to use highly effective birth control during the study
- Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04147858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.