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

NCT ID: NCT03249103

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2019-04-18

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.

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NYX-2925

Intervention Type: DRUG

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

Placebo oral capsule

Intervention Type: DRUG

Matching placebo capsules.

Interventions

NYX-2925

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

Intervention Type: DRUG

Placebo oral capsule

Matching placebo capsules.

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

inVentiv Health Clinical

OTHER

Sponsor Role: collaborator

Aptinyx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aptinyx Clinical Site

Ann Arbor, Michigan, United States

Aptinyx Clinical Site

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NYX-2925-2002

Identifier Type: -

Identifier Source: org_study_id