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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249103
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
inVentiv Health Clinical
Information provided by (Responsible Party):
Aptinyx

Tracking Information
First Submitted Date  ICMJE August 2, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE August 14, 2017
Actual Primary Completion Date April 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
Changes in markers of central pain processing as measured by functional magnetic resonance imaging. [ Time Frame: Screening through Week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Evaluate safety as measured by the incidence of adverse events [ Time Frame: Screening through Week 7 ]
  • Evaluate the safety as measure by the change in vital sign measurements [ Time Frame: Screening through Week 7 ]
  • Evaluate the changes in clinical laboratory test results [ Time Frame: Screening through Week 7 ]
  • Evaluate the changes in electrocardiogram results [ Time Frame: Screening through Week 7 ]
  • Evaluate the changes in physical examination findings [ Time Frame: Screening through Week 7 ]
  • Evaluating suicidal ideation and behavior as measure by the Columbia-Suicide Severity Rating Scale [ Time Frame: Screening through Week 7 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Official Title  ICMJE A Phase 2, Single-Blind, Exploratory, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Daily Oral NYX-2925 in Subjects With Fibromyalgia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
All subjects will receive NYX-2925 Low Dose, NYX-2925 High Dose, and placebo PO QD for 2 week treatment periods, then go into Follow-up for 1 week.
Masking: Single (Participant)
Masking Description:
Subjects are masked to when they taking NYX-2925 High Dose, NYX-2925 Low Dose, and Placebo.
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: NYX-2925
    NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
  • Drug: Placebo oral capsule
    Matching placebo capsules.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Up to 24 subjects will receive Placebo, NYX-2925 Low Dose, and NYX-2925 High Dose
    Intervention: Drug: Placebo oral capsule
  • Experimental: NYX-2925 High Dose
    Up to 24 subjects will receive High Dose of NYX-2925
    Intervention: Drug: NYX-2925
  • Experimental: NYX-2925 Low Dose
    Up to 24 subjects will receive Low Dose of NYX-2925
    Intervention: Drug: NYX-2925
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2019)
22
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
24
Actual Study Completion Date  ICMJE April 18, 2019
Actual Primary Completion Date April 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, gabapentinoids, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03249103
Other Study ID Numbers  ICMJE NYX-2925-2002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Aptinyx
Study Sponsor  ICMJE Aptinyx
Collaborators  ICMJE inVentiv Health Clinical
Investigators  ICMJE Not Provided
PRS Account Aptinyx
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP