ClinicalTrials.gg
CompletedNCT03249103Updated Sep 16, 2022Results posted

Evaluate the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

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

Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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:

  • Placebo PO Every Day (QD) for 2 weeks
  • NYX-2925 PO QD for 2 weeks (2x)
  • Follow-up for 1 week

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.

02

Conditions studied

  • Fibromyalgia

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Keywords

  • Fibromyalgia
03

In context

Fibromyalgia

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Subjects meets the 2010 American College of Rheumatology (ACR) criteria for fibromyalgia.
  2. Self-reported clinical pain ≥ 4 and on the Numeric Pain Rating Scale (NPRS) at screening and baseline.
  3. Subject receives and agrees to remain on their stable fibromyalgia treatment plan established at least 14 days prior to dosing.
  4. Subject agrees to use only non-steroidal anti-inflammatory (NSAID) or acetaminophen treatment as needed for breakthrough pain, and/or, zopiclone, zolpidem, zaleplon, or eszopiclone for sleep (if needed).
  5. Right handed.
  6. Calculates creatinine clearance ≥ 60 mL/minute.
  7. Female subjects of child bearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (e.g., surgical sterilization, oral or parenteral contraceptives, intrauterine device that is considered safe for MRI procedures, barrier [condom with spermicide]) and who do not plan to become pregnant, breastfeed, or donate ova during the course of the study and for 28 days after the final administration of investigational product.
  8. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.

Exclusion criteria

Exclusion Criteria:

  1. Current or expected use of opioid or narcotic analgesics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, gabapentins, topiramate, anticonvulsants, benzodiazepines, and sedatives, or hypnotics.
  2. Unstable doses of allowed antidepressants or muscle relaxants. Use of NSAIDs or acetaminophen 24 hours prior to imaging procedures is prohibited.
  3. Pain due to concurrent disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, or other chronic widespread pain condition(s) that may confound fibromyalgia pain.
  4. Untreated endocrine disorder that may confound fibromyalgia assessments.
  5. Psychiatric or cognitive disorder (e.g., current schizophrenia, severe depression, suicidal ideation, dementia, etc.).
  6. Clinically significant alcohol or other substance abuse within the last 2 years.
  7. Positive screen for medically inappropriate or illegal use of drugs of abuse.
  8. Current treatment with medications such as ketamine, amantadine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
  9. History of allergy, sensitivity, or intolerance to medications such as ketamine, amantadine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
  10. Women, who are pregnant, breast feeding, or planning to become pregnant or donate ova during the course of the study and for 28 days after the final administration of investigational product.
  11. Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or history of seizures, epilepsy, or strokes.
  12. Contraindications to fMRI procedures. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material.
  13. Current or habitual use (within the last 12 months) of artificial nails, nails enhancements, or nail extensions that cover any portion of either thumbnail.
  14. Abnormal laboratory results, medical history, or concurrent conditions that would preclude safe study participation, or interfere with study procedures/assessments.
  15. Impaired liver function.
  16. Known history of significant heart condition or high blood pressure.
  17. Current evidence of dysplasia or history of cancer malignancy (including lymphoma and leukemia) in the last 5 years.
  18. Human immunodeficiency virus (HIV) infection, hepatitis, or other ongoing infectious disease.
  19. History of severe kidney or liver impairment.
  20. History of migraine.
  21. History of lower limb vascular surgery or current lower limb vascular dysfunction.
  22. Received an investigational drug or device within 30 days of dosing.
  23. Previous treatment with NYX-2925.
  24. Resting heart rate \< 45 or ≥ 95 beats per minute.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    All subjects

    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

Interventions

  • NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).

  • DrugPlacebo oral capsule

    Matching placebo capsules.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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)

07

Results

Posted Sep 16, 2022

Participant flow

Participant flow — Overall Study
MilestoneAll Treated Subjects
Started22
Completed20
Not completed2

Outcome measures

PrimaryMean (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
Reported as:
Mean · ratio
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.
ratioAll Treated Subjects
dACC mean placebo2.1670 ± 0.17796
dACC mean NYX-2925 20 mg2.0550 ± 0.19710
dACC NYX-2925 200 mg2.0975 ± 0.19141
Statistical analysis
  • All Treated Subjects · t-test, 2 sided · p = 0.032
PrimaryMean (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
Reported as:
Mean · ratio
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.
ratioAll Treated Subjects
pINS mean placebo1.993 ± 0.13981
pINS mean NYX-2925 20 mg1.911 ± 0.14242
pINS NYX-2925 200 mg1.903 ± 0.16194
Statistical analysis
  • All Treated Subjects · t-test, 2 sided · p = 0.039
Other pre-specifiedMean 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)
Reported as:
Mean · units on a scale
Mean Change in Numeric Pain Rating Scale (NPRS) Score Assessing Average Pain in the Past 24 Hours
units on a scaleAll Treated Subjects
Baseline5.32 ± 1.411
Week 24.82 ± 1.275
Week 44.74 ± 1.360
Week 64.12 ± 1.650
Statistical analysis
  • All Treated Subjects · t-test, 2 sided · p = 0.0072comparing Week 2 (Placebo) to Week 6 (NYX-2925 200 mg)

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
All Treated Subjects0/22 (0%)0/22 (0%)7/22 (31.8%)
Most frequent other events
Most frequent other events
EventAll Treated Subjects
Abdominal distensionGastrointestinal disorders3/22
AnxietyPsychiatric disorders2/22
Diarrhoea/Gastrointestinal disorders2/22
EructationGastrointestinal disorders2/22
Tension headacheNervous system disorders2/22
Viral upper respiratory tract infectionInfections and infestations2/22

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Treated Subjects
Mean47.3 ± 15.06
Sex: Female, Male
Sex: Female, Male(Participants)All Treated Subjects
Female22
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Treated Subjects
Hispanic or Latino1
Not Hispanic or Latino21
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Treated Subjects
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American2
White19
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Treated Subjects
United States22
Fibromyalgia disease history, years
Fibromyalgia disease history, years(years)All Treated Subjects
Mean14.57 ± 14.476
08

Study locations

2 sites
  • Aptinyx Clinical Site
    Ann Arbor, Michigan 48109, United States
  • Aptinyx Clinical Site
    Cincinnati, Ohio 45220, United States
09

References and documents

Study documents

  • Study protocol · Mar 7, 2018
  • Statistical analysis plan · Nov 26, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2017
First posted
Aug 15, 2017
StartActual
Aug 14, 2017
Primary completionActual
Apr 18, 2019
CompletionActual
Apr 18, 2019
Results first posted
Sep 16, 2022
Last update
Sep 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03249103
Lead sponsor
Aptinyx
Collaborators
inVentiv Health Clinical
Responsible party
Sponsor
First posted
Aug 15, 2017
Start date
Aug 14, 2017
Primary completion
Apr 18, 2019
Completion
Apr 18, 2019
Results posted
Sep 16, 2022
Last update
Sep 16, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: NYX-2925

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