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Trial record 1 of 5 for:    NYX-2925
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Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04147858
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Aptinyx

Study Description
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Brief Summary:
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: NYX-2925 Drug: Placebo Phase 2

Detailed Description:

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with fibromyalgia.

The study will be 15-18 weeks in duration, including a 1-4 week screening period (dependent upon duration of analgesic medication washout period), followed by a 14-week double-blind, randomized, placebo-controlled treatment period. Subjects eligible for study will receive either NYX-2925 or placebo during the treatment period. All subjects will receive placebo at some point during the treatment period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomization algorithm, randomization allocation, allocation to study drug or placebo, timing for primary endpoints.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Experimental: NYX-2925 50 mg
NYX-2925 50 mg administered orally. At some point in the study, all subjects will receive placebo.
 Drug: NYX-2925
NYX-2925 administered orally
Experimental: NYX-2925 100 mg
NYX-2925 100 mg administered orally. At some point in the study, all subjects will receive placebo.
 Drug: NYX-2925
NYX-2925 administered orally
Placebo Comparator: Placebo
Placebo administered orally.
 Drug: Placebo
Placebo administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Change in the mean NRS score [ Time Frame: Up to Week 14 ]
    Change in the mean NRS score assessing average pain intensity in the past 24 hours from baseline


Secondary Outcome Measures :
  1. Daily Sleep Interference (DSIS) score [ Time Frame: Up to Week 14 ]
    Change from baseline in the mean Daily Sleep Interference (DSIS) score

  2. Patient Global Impression of Change (PGI-C) [ Time Frame: Up to Week 14 ]
    Patient Global Impression of Change (PGI-C)

  3. Percentage of subjects achieving ≥30% pain reduction [ Time Frame: Up to Week 14 ]
    Percentage of subjects achieving ≥30% pain reduction in the mean NRS average pain intensity from baseline

  4. Fibromyalgia Impact Questionnaire-Revised (FIQR) score [ Time Frame: Up to Week 14 ]
    Change from baseline in the Fibromyalgia Impact Questionnaire-Revised (FIQR) score

  5. Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) score [ Time Frame: Up to Week 14 ]
    Change from baseline in the Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) score

  6. Patient Reported Outcomes Measurement Information System - Firbomyalgia (PROMIS-FM) [ Time Frame: Up to Week 14 ]
    Change from baseline in the Patient Reported Outcomes Measurement Information System - Firbomyalgia (PROMIS-FM)


Other Outcome Measures:
  1. Other Endpoints [ Time Frame: Up to Week 14 ]
    Adverse Events


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Institutional Review Board approved written informed consent and privacy language (Health Insurance Portability and Accountability Act (HIPAA)) authorization.
  2. Consent to being included in a research subject database.
  3. ≥18 and ≤75 years of age.
  4. Meets the 2016 American College of Rheumatology criteria for fibromyalgia
  5. Fibromyalgia was diagnosed >1 year prior to Screening.
  6. Score of ≥4 and ≤9 on the 11-point NRS for average pain over the past 24 hours at Visit 1.
  7. Subject agrees to use only acetaminophen treatment as needed for breakthrough pain related to fibromyalgia.
  8. Subject agrees not to initiate or change any non-pharmacologic interventions during the study.
  9. Body mass index (BMI) ≤40 kg/m2.
  10. Calculated creatinine clearance is ≥60 mL/minute/1.73m2 (Cockcroft-Gault formula).
  11. Absence of impaired hepatic function.

Inclusion Criteria: Randomization Daily pain scores and diary compliance will be transferred into the interactive response technology system, which will be used to assess the criteria for randomization. Subjects whose mean of the daily average pain intensity score during the preceding 7 (±1) days is within the protocol-defined algorithm and with adequate compliance with daily diary completion will be eligible for randomization.

Exclusion Criteria:

  1. Lifetime history of any psychotic and/or bipolar disorder.
  2. Uncontrolled major depressive disorder or generalized anxiety disorder
  3. Pain that would confound or interfere with the assessment of the subject's fibromyalgia pain.
  4. Concurrent autoimmune, infectious, or inflammatory disease.
  5. An untreated endocrine disorder that may confound fibromyalgia assessments.
  6. History of severe renal impairment.
  7. Known history of significant cardiovascular condition.
  8. Resting heart rate <45 bpm or >95 bpm.
  9. History of Huntington's disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, or a history of seizures, epilepsy, or stroke.
  10. Ongoing clinically significant infectious disease.
  11. Concomitant use of protocol specified prohibited medications.
  12. Sensitivity, allergy to, or concomitant use of, N-methyl-D-aspartate receptor ligands.
  13. Use of NMDAR-binding drugs within 30 days prior to dosing or during the study.
  14. Current or recent history of a substance use disorder.
  15. Positive urine drug screen or positive breathalyzer test for alcohol.
  16. Meets the criteria for suicidal intent, plan and/ or behavior
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147858


Contacts
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Contact: Aptinyx Clinical Development 847 871 0377 ext 1 clinicalstudies@aptinyx.com

Locations
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United States, Arizona
Aptinyx Clinical Site Recruiting
Chandler, Arizona, United States, 85224
Aptinyx Clinical Site Recruiting
Glendale, Arizona, United States, 85306
Aptinyx Clinical Site Recruiting
Mesa, Arizona, United States, 85206
Aptinyx Clinical Site Recruiting
Phoenix, Arizona, United States, 85050
Aptinyx Clinical Site Recruiting
Tucson, Arizona, United States, 85741
United States, California
Aptinyx Clinical Site Recruiting
Carlsbad, California, United States, 92008
Aptinyx Clinical Site Recruiting
Santa Rosa, California, United States, 95405
United States, Colorado
Aptinyx Clinical Site Recruiting
Centennial, Colorado, United States, 80113
United States, Florida
Aptinyx Clinical Site Recruiting
Pinellas Park, Florida, United States, 33781
United States, Illinois
Aptinyx Clinical Site Recruiting
Chicago, Illinois, United States, 60602
United States, Indiana
Aptinyx Clinical Site Recruiting
Evansville, Indiana, United States, 47714
United States, Minnesota
Aptinyx Clinical Site Recruiting
Richfield, Minnesota, United States, 55423
United States, Missouri
Aptinyx Clinical Site Recruiting
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Aptinyx Clinical Site Recruiting
Omaha, Nebraska, United States, 68144
United States, New York
Aptinyx Clinical Site Recruiting
Jamaica, New York, United States, 11432
United States, Ohio
Aptinyx Clinical Site Recruiting
Cincinnati, Ohio, United States, 45219
Aptinyx Clinical Site Recruiting
Cincinnati, Ohio, United States, 45236
Aptinyx Clinical Site Recruiting
Columbus, Ohio, United States, 43212
United States, Oklahoma
Aptinyx Clinical Site Recruiting
Oklahoma City, Oklahoma, United States, 73111
United States, South Carolina
Aptinyx Clinical Site Recruiting
Anderson, South Carolina, United States, 29621
Aptinyx Clinical Site Recruiting
Greer, South Carolina, United States, 29651
United States, Texas
Aptinyx Clinical Site Recruiting
Dallas, Texas, United States, 75234
Aptinyx Clinical Site Recruiting
Plano, Texas, United States, 75093
Aptinyx Clinical Site Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Aptinyx Clinical Site Recruiting
Murray, Utah, United States, 84123
Sponsors and Collaborators
Aptinyx
Syneos Health
More Information
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Responsible Party: Aptinyx
ClinicalTrials.gov Identifier: NCT04147858    
Other Study ID Numbers: NYX-2925-2005
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases