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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 : September 9, 2021
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Aptinyx

Tracking Information
First Submitted Date  ICMJE October 29, 2019
First Posted Date  ICMJE November 1, 2019
Last Update Posted Date September 9, 2021
Actual Study Start Date  ICMJE November 12, 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
  • Patient Global Impression of Change (PGI-C) [ Time Frame: Week 12 ]
    Percentage of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12
  • Daily Sleep Interference (DSIS) score [ Time Frame: Week 12 ]
    Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12
  • Percentage of subjects achieving ≥30% pain reduction [ Time Frame: Week 12 ]
    Percentage of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12
  • Percentage of subjects achieving ≥50% pain reduction [ Time Frame: Week 12 ]
    Percentage of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12
  • Fibromyalgia Impact Questionnaire-Revised (FIQR) score [ Time Frame: Week 12 ]
    Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score
  • Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) sleep disturbance score [ Time Frame: Week 12 ]
    Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score
  • Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) fatigue profile score [ Time Frame: Week 12 ]
    Change from baseline to Week 12 in the PROMIS-FM fatigue profile score
  • Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) physical function score [ Time Frame: Week 12 ]
    Change from baseline to Week 12 in the PROMIS-FM physical function score
  • Cumulative response (percent reduction from baseline) in weekly mean NRS [ Time Frame: Week 12 ]
    Cumulative response (percent reduction from baseline) in the weekly mean NRS average pain intensity at Week 12
  • Use of rescue medication [ Time Frame: Week 12 ]
    Use of rescue medication, including the proportion of subjects using rescue medication, the frequency and amount used
  • Change in the mean NRS score at each week [ Time Frame: Week 1 - Week 12 ]
    Change from baseline in the weekly mean of the daily Numerical Rating Scale (NRS) at each week from Week 1 through Week 12
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Daily Sleep Interference (DSIS) score [ Time Frame: Up to Week 14 ]
    Change from baseline in the mean Daily Sleep Interference (DSIS) score
  • Patient Global Impression of Change (PGI-C) [ Time Frame: Up to Week 14 ]
    Patient Global Impression of Change (PGI-C)
  • 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
  • Fibromyalgia Impact Questionnaire-Revised (FIQR) score [ Time Frame: Up to Week 14 ]
    Change from baseline in the Fibromyalgia Impact Questionnaire-Revised (FIQR) score
  • 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
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: October 30, 2019)
Other Endpoints [ Time Frame: Up to Week 14 ]
Adverse Events
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: NYX-2925
    NYX-2925 administered orally
  • Drug: Placebo
    Placebo administered orally
Study Arms  ICMJE
  • Experimental: NYX-2925 50 mg
    NYX-2925 50 mg administered orally.
    Intervention: Drug: NYX-2925
  • Experimental: NYX-2925 100 mg
    NYX-2925 100 mg administered orally.
    Intervention: Drug: NYX-2925
  • Placebo Comparator: Placebo
    Placebo administered orally.
    Intervention: Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aptinyx Clinical Development 847 871 0377 ext 1 clinicalstudies@aptinyx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04147858
Other Study ID Numbers  ICMJE NYX-2925-2005
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: No
Responsible Party Aptinyx
Study Sponsor  ICMJE Aptinyx
Collaborators  ICMJE Worldwide Clinical Trials
Investigators  ICMJE Not Provided
PRS Account Aptinyx
Verification Date September 2021

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