Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

Study Overview
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Brief Summary
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To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: NYX-2925
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NYX-2925 50 mg<br>NYX-2925 50 mg administered orally. | Drug: NYX-2925<br>* NYX-2925 administered orally<br>|
| Experimental: NYX-2925 100 mg<br>NYX-2925 100 mg administered orally. | Drug: NYX-2925<br>* NYX-2925 administered orally<br>|
| Placebo Comparator: Placebo<br>Placebo administered orally. | Drug: Placebo<br>* Placebo administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Mean Numerical Rating Scale (NRS) Score | 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) | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Much Improved or Very Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12 | Number of subjects much improved or very much improved on the Patient Global Impression of Change (PGI-C) at Week 12 | Week 12 | 
| Daily Sleep Interference (DSIS) Score | 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. | Week 12 | 
| Number of Subjects Achieving ≥30% Pain Reduction | 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). | Week 12 | 
| Number of Subjects Achieving ≥50% Pain Reduction | 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) | Week 12 | 
| Fibromyalgia Impact Questionnaire-Revised (FIQR) Score | 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 | Week 12 | 
| Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score | 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. | Week 12 | 
| Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score | 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 | Week 12 | 
| Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score | 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. | Week 12 | 
| Use of Rescue Medication | The number of subjects using rescue medication. | Week 12 |