A Phase 2 interventional study of NYX-2925 and Placebo oral capsule in Fibromyalgia, sponsored by Aptinyx. Completed at 2 sites in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by Aptinyx · Phase 2, Interventional, and Treatment
The primary objective is to determine whether daily dosing with NYX-2925 changes markers of central pain processing in subjects with fibromyalgia by evaluating changes in evoked pain, and visual stimulation, functional magnetic resonance imaging (fMRI), resting state function connectivity magnetic resonance imaging (rs-fcMRI) and proton magnetic resonance spectroscopy (H-MRS) in fibromyalgia subjects on active drug versus placebo.
This is a single-blind, exploratory, placebo-controlled, pilot study to assess the efficacy and safety of daily oral NYX-2925 in fibromyalgia subjects. The study will include a screening period (up to 30 days), a placebo period, an active treatment period with, and a follow-up period as follows:
Eligible subjects will receive MRIs during the screening period, during the placebo period, during the NYX-2925 PO QD period. Safety assessments will be conducted and adverse events will be collected during the study. Daily pain scores and other fibromyalgia scales will be collected during the study. Daily pain scores and other fibromyalgia scales will be collected for exploratory analysis. During the follow-up period, an optional MRI will be completed for consenting subjects in order to evaluate duration of effect.
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Aptinyx is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Up to 24 subjects will receive placebo, NYX-2925 20 mg QD, and NYX-2925 200 mg QD for sequential 2 week treatment periods, then go into Follow-up for 1 week.
Drug: NYX-2925 · Drug: Placebo oral capsule
NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Matching placebo capsules.
Mean (SD) Glx/Total Creatine Levels in Dorsal Anterior Cingulate Cortex (dACC): NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively.
Time frame: Week 2, Week 4, Week 6
Mean (SD) Changes in Posterior Insula (pINS) Glx/Total Creatine Levels Before and After Acute Painful Pressure Stimulation: NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively.
Time frame: Week 2, Week 4, and Week 6
Mean Change in Numeric Pain Rating Scale (NPRS) Score Assessing Average Pain in the Past 24 Hours
Numeric pain rating scale is a unidimensional segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of their pain, where 0 represents no pain and 10 the worst pain imaginable.
Time frame: Change from Baseline, Week 2 (Placebo), Week 4, and Week 6 (NYX-2925)
| Milestone | All Treated Subjects |
|---|---|
| Started | 22 |
| Completed | 20 |
| Not completed | 2 |
| ratio | All Treated Subjects |
|---|---|
| dACC mean placebo | 2.1670 ± 0.17796 |
| dACC mean NYX-2925 20 mg | 2.0550 ± 0.19710 |
| dACC NYX-2925 200 mg | 2.0975 ± 0.19141 |
| ratio | All Treated Subjects |
|---|---|
| pINS mean placebo | 1.993 ± 0.13981 |
| pINS mean NYX-2925 20 mg | 1.911 ± 0.14242 |
| pINS NYX-2925 200 mg | 1.903 ± 0.16194 |
Numeric pain rating scale is a unidimensional segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of their pain, where 0 represents no pain and 10 the worst pain imaginable.
| units on a scale | All Treated Subjects |
|---|---|
| Baseline | 5.32 ± 1.411 |
| Week 2 | 4.82 ± 1.275 |
| Week 4 | 4.74 ± 1.360 |
| Week 6 | 4.12 ± 1.650 |
Collected over Adverse events were collected from the time the informed consent was signed to the end of the subject's participation in the study (Week 7).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Treated Subjects | 0/22 (0%) | 0/22 (0%) | 7/22 (31.8%) |
| Event | All Treated Subjects |
|---|---|
| Abdominal distensionGastrointestinal disorders | 3/22 |
| AnxietyPsychiatric disorders | 2/22 |
| Diarrhoea/Gastrointestinal disorders | 2/22 |
| EructationGastrointestinal disorders | 2/22 |
| Tension headacheNervous system disorders | 2/22 |
| Viral upper respiratory tract infectionInfections and infestations | 2/22 |
| Age, Continuous(years) | All Treated Subjects |
|---|---|
| Mean | 47.3 ± 15.06 |
| Sex: Female, Male(Participants) | All Treated Subjects |
|---|---|
| Female | 22 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | All Treated Subjects |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Treated Subjects |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Treated Subjects |
|---|---|
| United States | 22 |
| Fibromyalgia disease history, years(years) | All Treated Subjects |
|---|---|
| Mean | 14.57 ± 14.476 |
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Plan to share: Yes
Ran from Aug 2017 to primary completion in Apr 2019, 20 months.
Results were first posted in Sep 2022, 3 years 4 months after primary completion.
Of 24 phase 2 interventional studies under Fibromyalgia, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's 20 months is close to that.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: NYX-2925
Aptinyx