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

NCT03249103 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NYX-2925-2002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Change from Baseline, Week 2 (Placebo), Week 4, and Week 6 (NYX-2925)

Study Arms (1)

All subjects

EXPERIMENTAL

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 DRUG

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

All subjects

Placebo oral capsule DRUG

Matching placebo capsules.

All subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meets the 2010 American College of Rheumatology (ACR) criteria for fibromyalgia.
• Self-reported clinical pain ≥ 4 and on the Numeric Pain Rating Scale (NPRS) at screening and baseline.
• Subject receives and agrees to remain on their stable fibromyalgia treatment plan established at least 14 days prior to dosing.
• 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).
• Right handed.
• Calculates creatinine clearance ≥ 60 mL/minute.
• 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.
• 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.

You may not qualify if:

• Current or expected use of opioid or narcotic analgesics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, gabapentins, topiramate, anticonvulsants, benzodiazepines, and sedatives, or hypnotics.
• Unstable doses of allowed antidepressants or muscle relaxants. Use of NSAIDs or acetaminophen 24 hours prior to imaging procedures is prohibited.
• 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.
• Untreated endocrine disorder that may confound fibromyalgia assessments.
• Psychiatric or cognitive disorder (e.g., current schizophrenia, severe depression, suicidal ideation, dementia, etc.).
• Clinically significant alcohol or other substance abuse within the last 2 years.
• Positive screen for medically inappropriate or illegal use of drugs of abuse.
• Current treatment with medications such as ketamine, amantadine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
• History of allergy, sensitivity, or intolerance to medications such as ketamine, amantadine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
• 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.
• Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or history of seizures, epilepsy, or strokes.
• Contraindications to fMRI procedures. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material.
• Current or habitual use (within the last 12 months) of artificial nails, nails enhancements, or nail extensions that cover any portion of either thumbnail.
• Abnormal laboratory results, medical history, or concurrent conditions that would preclude safe study participation, or interfere with study procedures/assessments.
• Impaired liver function.

Sponsors & Collaborators

• Aptinyx: lead
• inVentiv Health Clinical: collaborator

Study Sites (2)

Aptinyx Clinical Site

Ann Arbor, Michigan, 48109, United States

Location

Aptinyx Clinical Site

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

NYX-2925

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Aptinyx Clinical Development
• Organization: Aptinyx

clinicalstudies@aptinyx.com

847-871-0377

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Subjects are masked to the sequence in which they are taking placebo QD, NYX-2925 20 mg QD, NYX-2925 200 mg QD.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will receive placebo, NYX-2925 20 mg QD, NYX-2925 200 mg QD for sequential 2 week treatment periods, then go into Follow-up for 1 week.

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 15, 2017
• Study Start: August 14, 2017
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: September 16, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)