FibromyalgiaPhase 2NCT04147858

Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

A Phase 2 study testing NYX-2925 in people with Fibromyalgia, run by Aptinyx at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Fibromyalgia
What is being tested?: NYX-2925
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 310 participants
Where: 42 sitesUnited States
Study dates: 12 Nov 2019to 16 Jun 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

42 sites in 1 country.

City, postcode or hospital

42 sites in 1 country

United States42 sites

Aptinyx Clinical Site
Alpharetta, Georgia, 30022
Aptinyx Clinical Site
Austin, Texas, 78737
Aptinyx Clinical Site
Bellevue, Washington, 98007
Aptinyx Clinical Site
Brooklyn, New York, 11235
Aptinyx Clinical Site
Chicago, Illinois, 60607
Aptinyx Clinical Site
Cincinnati, Ohio, 45219
Aptinyx Clinical Site
Culver City, California, 90230
Aptinyx Clinical Site
Danville, Virginia, 24541
Aptinyx Clinical Site
Duncansville, Pennsylvania, 16635
Aptinyx Clinical Site
Evansville, Indiana, 47714
Aptinyx Clinical Site
Fernandina Beach, Florida, 32034
Aptinyx Clinical Site
Flossmoor, Illinois, 60422
Aptinyx Clinical Site
Fresno, California, 93710
Aptinyx Clinical Site
Gurnee, Illinois, 60031
Aptinyx Clinical Site
Hazelwood, Missouri, 63042
Aptinyx Clinical Site
Houston, Texas, 77077
Aptinyx Clinical Site
Jacksonville, Florida, 32224
Aptinyx Clinical Site
Jacksonville, Florida, 32256
Aptinyx Clinical Site
Lady Lake, Florida, 32159
Aptinyx Clinical Site
Las Vegas, Nevada, 89102
Aptinyx Clinical Site
Memphis, Tennessee, 38119
Aptinyx Clinical Site
Miami, Florida, 33165
Aptinyx Clinical Site
New York, New York, 10017
Aptinyx Clinical Site
New York, New York, 10036
Aptinyx Clinical Site
Newton, Kansas, 67114
Aptinyx Clinical Site
Oklahoma City, Oklahoma, 73106
Aptinyx Clinical Site
Omaha, Nebraska, 68114
Aptinyx Clinical Site
Orange, California, 92868
Aptinyx Clinical Site
Orlando, Florida, 32801
Aptinyx Clinical Site
Palmetto Bay, Florida, 33157
Aptinyx Clinical Site
Phoenix, Arizona, 85012
Aptinyx Clinical Site
Prairie Village, Kansas, 66208
Aptinyx Clinical Site
Redlands, California, 92374
Aptinyx Clinical Site
Roslindale, Massachusetts, 02131
Aptinyx Clinical Site
Skokie, Illinois, 60076
Aptinyx Clinical Site
Staten Island, New York, 10312
Aptinyx Clinical Site
Temecula, California, 92591
Aptinyx Clinical Site
Torrance, California, 90502
Aptinyx Clinical Site
West Des Moines, Iowa, 50265
Aptinyx Clinical Site
Wichita, Kansas, 67205
Aptinyx Clinical Site
Williamsville, New York, 14221
Aptinyx Clinical Site
Winter Park, Florida, 32789

Other trials in United States

About this study

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

To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.

Read the 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.

Conditions: Fibromyalgia
Being tested: NYX-2925, Placebo
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NYX-2925Drug
NYX-2925 administered orally
PlaceboDrug
Placebo administered orally

Study groups in NCT04147858
Study group	Role	What they receive
NYX-2925 50 mg	Experimental	NYX-2925 50 mg administered orally. Receives: Drug: NYX-2925
NYX-2925 100 mg	Experimental	NYX-2925 100 mg administered orally. Receives: Drug: NYX-2925
Placebo	Placebo comparator	Placebo administered orally. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Week 12

Secondary outcomes (9)

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
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Week 12
Use of Rescue Medication
The number of subjects using rescue medication.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 201916 Jun 2022

First posted1 Nov 2019
Study start12 Nov 2019
Primary completion16 Jun 2022
Study completion16 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 310 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04147858
Sponsor's protocol ID: NYX-2925-2005
Status last verified: Apr 2023
First submitted: 29 Oct 2019
Last updated: 28 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome

All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
ClinicalTrials.gov ID: NCT04147858
Acronym / sponsor ID: NYX-2925-2005
Conditions: Fibromyalgia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 310 participants (actual)
Lead sponsor: AptinyxIndustry (pharma, biotech, devices)
Collaborators: Worldwide Clinical Trials
Study start: 12 Nov 2019 (actual)
Primary completion: 16 Jun 2022 (actual)
Study completion: 16 Jun 2022 (actual)
First posted: 1 Nov 2019 (actual)
Results: Posted 28 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
NYX-2925 50 mg	Experimental	Drug: NYX-2925NYX-2925 50 mg administered orally.
NYX-2925 100 mg	Experimental	Drug: NYX-2925NYX-2925 100 mg administered orally.
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered orally.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NYX-2925NYX-2925 administered orally	Drug	NYX-2925 100 mg, NYX-2925 50 mg
PlaceboPlacebo administered orally	Drug	Placebo

Primary outcome

Change in the Mean Numerical Rating Scale (NRS) Score
Time frame: 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)

9 secondary outcomes

Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12
Time frame: Week 12
Daily Sleep Interference (DSIS) Score
Time frame: Week 12
Number of Subjects Achieving ≥30% Pain Reduction
Time frame: Week 12
Number of Subjects Achieving ≥50% Pain Reduction
Time frame: Week 12
Fibromyalgia Impact Questionnaire-Revised (FIQR) Score
Time frame: Week 12
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score
Time frame: Week 12
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score
Time frame: Week 12
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score
Time frame: Week 12
Use of Rescue Medication
Time frame: Week 12

Results and safety

Results posted to the registry on 28 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NYX-2925 50 mg	101	84
NYX-2925 100 mg	104	82
Placebo	105	85

Primary outcome: Change in the Mean Numerical Rating Scale (NRS) Score

Time frame: Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	NYX-2925 50 mg n = 101	NYX-2925 100 mg n = 104	Placebo n = 104
Value	-1.26 (1.603)	-1.47 (1.983)	-1.23 (1.846)

NYX-2925 50 mg vs Placebo: p = 0.539, t-test, 2 sided
NYX-2925 100 mg vs Placebo: p = 0.425, t-test, 2 sided

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NYX-2925 50 mg	0 of 101 (0%)	18 of 101 (17.8%)	0 of 101
NYX-2925 100 mg	2 of 104 (1.9%)	19 of 104 (18.3%)	0 of 104
Placebo	0 of 105 (0%)	18 of 105 (17.1%)	0 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

42 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NYX-2925 in people with Fibromyalgia, run by Aptinyx at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Mean Numerical Rating Scale (NRS) Score (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04147858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.